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\def\citeauthor{~Muppavarapu~Anusha,
              ~Vanitha~K}
\def\citetitle{\textbf{Formulation and Evaluation of Immediate-Release Tablets of Edoxaban Tosylate}}
\def\copyrightstmt{This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.}
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\begin{document}


\def\RunningAuthor{Muppavarapu Anusha and Vanitha K}
\firstPage{177}
\articleType{Original Article}
\receivedDate{02 Sep 2022}
\acceptedDate{17 Sep 2022}
\revisedDate{15 Sep 2022}
\journalVolume{1}
\journalIssue{4}
\journalDoi{ijebr.v1i4.394}
\copyrightYear{2022}
\eISSN{2583-5254}
\journalDoi{ijebr.v1i4.394}
\def\authorCount{2}
\def\affCount{1}

\def\journalTitle{International Journal of Experimental and Biomedical Research}

\title{\textbf{Formulation and Evaluation of Immediate-Release Tablets of Edoxaban Tosylate}}
\author{Muppavarapu~Anusha\textsuperscript{*}, 
            Vanitha~K~\\[5pt]{Department of Pharmaceutics, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Medak, Telangana, India}}

\begin{abstract}
The immediate-release dosage form breaks down quickly and gets dissolved to release the medicaments. Immediate-release drug delivery is suitable for drugs having long biological half-life, high bioavailability, lower clearance, and lower elimination half-life. The basic design of the system consists of a rapid-release core. The core tablets were prepared using rapid Mixer Granulation and Fluidized bed Granulation Technique. The Mixture was blended further with the addition of Crospovidone and Magnesium Stearate. Nine (F1-F9) formulations of the core were prepared using NF Pharma and HPC-L Nippon Soda as binders in different proportions (2, 3 \& 4 \%w/w) to study the effect of variable concentrations of these on the characteristics of the formulation. The core blend was evaluated for Flow properties, Hardness, Thickness, Friability, and \textit{in-vitro} drug release. The drug (Edoxaban) is compatible with all excipients. All the parameters were in the optimum range. Among the Nine formulations F8 containing  HPC Nippon Soda (2\%) as a binder showed a better drug release of 100\% over 60 minutes was selected. 400mg of resultant powder blend was manually compressed at a pressure of 100 tablets, with  10.60mm punch and die to obtain the core tablet. Among these, F8 was optimize based percent of drug release (99\% of drug release in 60 minutes). 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Immediate Release Tablet,\newline Edoxaban,\newline Wet Granulation Method,\newline Fluidized Bed Granulation,\newline Rapid Mixer Granulation,\newline In-Vitro Dissolution Studies
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Muppavarapu~Anusha~\\ Phone:\ +91 9908553720~\\  Email:\ anushabapuji21@gmail.com
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        \makeatother
        
    
\section{Introduction}
The definition of immediate delivery for drugs is a strategy in which galenic controls do not overtly or intentionally slow down the pace at which medications arrive or, maybe, are assimilated from the body. Immediate delivery dosage structures disintegrate quickly to distribute the medication. In the present situation, prompt delivery of a suitable chemically acceptable diluent or transporter may be administered \unskip~\cite{1649224:26836496}. Quick delivery drug conveyance is appropriate for pharmaceuticals with lengthy natural half-lives, high bioavailability, lesser freedom, and lower disposal half-lives. In any event, the unpleasant solvency of the medication and the need for the quick activity of drugs to cure undesired blemish or illness are the primary requirements for sure-fire discharge measurements structure. Edoxaban Tosylate, an anticoagulant medication, inhibits coagulation component Xa\ensuremath{^{1}} when taken orally (activated factor X). It is used to treat pulmonary embolism and deep vein thrombosis. It is an anticoagulant, a platelet aggregation inhibitor, and a coagulation aspect Xa inhibitor \unskip~\cite{1649224:26836500}.
    
\section{Materials and Methods}
Edoxaban tosylate gift sample from S D Fine Chemicals Ltd, Mumbai, Microcrystalline cellulose, Pregelatinized starch, Crospovidone, HPC-L Nipponsoda, Hydroxypropyl cellulose LF, Magnesium stearate, is from Ranbaxy fine Chemical Ltd, New Delhi, India.

\textbf{Methodology}

\textbf{Preformulation Studies}

\textbf{Pre-Compression Parameters}

\textbf{Bulk Density}

Bulk density is a given powder mass's ratio and bulk volume. It is determined by transferring an accurately weighed powder sample to the graduated cylinder. The ratio of the Weight of the model to the book it occupied was calculated \unskip~\cite{1649224:26836498,1649224:26836499}.

$\style{font-family:'Times New Roman'}{\style{font-size:8px}{Bulk\;density\;=\;Mass\;of\;the\;blend\;/Bulk\;volume\;of\;the\;blend}} $

\textbf{Tapped Density}

The device was programmed for 500, 750, and 1250 taps. The tapped density was determined by dividing the Mass of the blend by the tapped volume. It was created by pouring a known amount of the mix into a graduated cylinder and setting it on the device.

$\style{font-family:'Times New Roman'}{\style{font-size:8px}{Tapped\;density\;=\;Mass\;of\;the\;blend\;/Tapped\;volume}} $

\textbf{Angle of Repose }

The Angle of repose by passing the Mixture through a funnel fixed to a burette stand at a particular height (4 cm). The Height and radius of the pile were measured [Table~\ref{tw-6674a06bc302}]. The Angle of repose of the blend was calculated using the formula:
\begin{eqnarray*}\theta=\tan^{-1}\left(\frac hr\right) \end{eqnarray*}
Where, 

h = Height of the pile; 

 r = Radius of the pile


\begin{table*}[!htbp]
\caption{\boldmath {Angle of Repose} }
\label{tw-6674a06bc302}
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\begin{tabulary}{\linewidth}{p{\dimexpr.49339999999999996\linewidth-2\tabcolsep}p{\dimexpr.50660000000000004\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Angle of Repose (Degrees) & \cAlignHack Flow Property\\
\tblmidrule 
\cAlignHack 25-30 &
  \cAlignHack Excellent\\
\cAlignHack 31-35 &
  \cAlignHack Good\\
\cAlignHack 36-40 &
  \cAlignHack Fair\\
\cAlignHack 41-45 &
  \cAlignHack Possible\\
\cAlignHack 46-55 &
  \cAlignHack Poor\\
\cAlignHack 56-65 &
  \cAlignHack Very poor\\
\cAlignHack {\textgreater}66 &
  \cAlignHack Very very poor\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Car's Index} }
\label{tw-8173c3c3468d}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.482\linewidth-2\tabcolsep}p{\dimexpr.518\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Compressibility Index (\%) & \cAlignHack Flow Property\\
\tblmidrule 
\cAlignHack {\textless}10\% &
  \cAlignHack Excellent\\
\cAlignHack 11-15 &
  \cAlignHack Good\\
\cAlignHack 16-20 &
  \cAlignHack Fair\\
\cAlignHack 21-25 &
  \cAlignHack Possible\\
\cAlignHack 26-31 &
  \cAlignHack Poor\\
\cAlignHack 32-37 &
  \cAlignHack Very poor\\
\cAlignHack {\textgreater}38 &
  \cAlignHack Very very poor\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Hausner's Ratio} }
\label{tw-252747fcd148}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.50410000000000004\linewidth-2\tabcolsep}p{\dimexpr.49589999999999996\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack  Flow Properties & \cAlignHack Hausner's Ratio\\
\tblmidrule 
\cAlignHack Excellent &
  \cAlignHack 1.0-1.11\\
\cAlignHack Good &
  \cAlignHack 1.12-1.18\\
\cAlignHack Fair &
  \cAlignHack 1.19-1.25\\
\cAlignHack Possible &
  \cAlignHack 1.26-1.34\\
\cAlignHack Poor &
  \cAlignHack 1.35-1.45\\
\cAlignHack Very poor &
  \cAlignHack 1.46-1.59\\
\cAlignHack Very very poor &
  \cAlignHack {\textgreater}1.60\\
\tblbottomrule 
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\begin{table*}[!htbp]
\caption{\boldmath {Drug and Excipient Ratios} }
\label{tw-0cff6f25aa2e}
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\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Name of the Material & \cAlignHack The Ratio of Active to Excipients\\
\tblmidrule 
\cAlignHack Edoxaban tosylate &
  \cAlignHack 50mg\\
\cAlignHack Microcrystalline cellulose &
  \cAlignHack 1:1\\
\cAlignHack Pregelatinized Starch &
  \cAlignHack 1:3\\
\cAlignHack Crospovidone &
  \cAlignHack 1:1\\
\cAlignHack Hydroxy Propyl Cellulose &
  \cAlignHack 1:1\\
\cAlignHack Magnesium stearate &
  \cAlignHack 1:0.5\\
\cAlignHack Iron oxide Yellow &
  \cAlignHack 1:0.5\\
\cAlignHack All excipients &
  \cAlignHack NA\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Operating Procedure} }
\label{tw-35971e6c411c}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.4618\linewidth-2\tabcolsep}p{\dimexpr.5382\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Parameters & \cAlignHack Specifications\\
\tblmidrule 
\cAlignHack Column details \& Description &
  \cAlignHack Zorbax eclipse XDB-C18 250\ensuremath{\times}4.6 mm, 5\ensuremath{\mu}m\\
\cAlignHack Flow rate &
  \cAlignHack 0.6mL /min\\
\cAlignHack Wavelength &
  \cAlignHack 260nm\\
\cAlignHack Colum temperature &
  \cAlignHack 40\ensuremath{^\circ}C\\
\cAlignHack Injection Volume &
  \cAlignHack 10\ensuremath{\mu}L\\
\cAlignHack Run Time &
  \cAlignHack 70 minutes\\
\cAlignHack Mode of Elution  &
  \cAlignHack Gradient\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Gradient Table} }
\label{tw-9ceb25b6ce98}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.3098\linewidth-2\tabcolsep}p{\dimexpr.3502\linewidth-2\tabcolsep}p{\dimexpr.34\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Time in Minutes & \cAlignHack Mobile Phase-A in \% & \cAlignHack Mobile Phase-B in \%\\
\tblmidrule 
\cAlignHack 0 &
  \cAlignHack 80 &
  \cAlignHack 20\\
\cAlignHack 5 &
  \cAlignHack 80 &
  \cAlignHack 20\\
\cAlignHack 10 &
  \cAlignHack 70 &
  \cAlignHack 30\\
\cAlignHack 30 &
  \cAlignHack 50 &
  \cAlignHack 50\\
\cAlignHack 60 &
  \cAlignHack 50 &
  \cAlignHack 50\\
\cAlignHack 61 &
  \cAlignHack 80 &
  \cAlignHack 20\\
\cAlignHack 70 &
  \cAlignHack 80 &
  \cAlignHack 20\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Inject the Sample as per the Sequence Below} }
\label{tw-8e0ad901da3b}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.473\linewidth-2\tabcolsep}p{\dimexpr.527\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Sample ID & \cAlignHack No. of Injections\\
\tblmidrule 
\cAlignHack Blank &
  \cAlignHack 1\\
\cAlignHack Placebo &
  \cAlignHack 1\\
\cAlignHack Standard &
  \cAlignHack 6\\
\cAlignHack Sample(s) &
  \cAlignHack 1\\
\cAlignHack Blank &
  \cAlignHack 1\\
\cAlignHack Bracketing standard (after every 6 sample injections) &
  \cAlignHack 1\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {System Suitability Criteria} }
\label{tw-c694c1f3349d}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.53370000000000005\linewidth-2\tabcolsep}p{\dimexpr.46629999999999995\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Parameter & \cAlignHack Criteria\\
\tblmidrule 
\cAlignHack Retention Time &
  \cAlignHack About 34.0 mins\\
\cAlignHack \%RSD for six replicate injections of Edoxaban in standard &
  \cAlignHack NMT 10.0\\
\cAlignHack Column Efficiency of Edoxaban standard &
  \cAlignHack NMT 2000 theroretical plates\\
\cAlignHack Tailing factor of edoxaban in standard &
  \cAlignHack NMT 2.0\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Impurity Name with RRT} }
\label{tw-418c28992ee5}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2221\linewidth-2\tabcolsep}p{\dimexpr.4379\linewidth-2\tabcolsep}p{\dimexpr.34\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack S. No & \cAlignHack Impurity Name & \cAlignHack RRT\\
\tblmidrule 
\cAlignHack 1 &
  \cAlignHack MITICA &
  \cAlignHack 0.22\\
\cAlignHack 2 &
  \cAlignHack ADCCPO &
  \cAlignHack 0.92\\
\cAlignHack 3 &
  \cAlignHack TCPAODCC &
  \cAlignHack 2.10\\
\cAlignHack 4 &
  \cAlignHack DCBCPO &
  \cAlignHack 2.25\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Composition of Edoxaban Tosylate Tablets} }
\label{tw-86246957924d}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.0477\linewidth-2\tabcolsep}p{\dimexpr.1298\linewidth-2\tabcolsep}p{\dimexpr.1031\linewidth-2\tabcolsep}p{\dimexpr.079399999999999995\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack  & \cAlignHack  & \multicolumn{3}{p{\dimexpr(.2725\linewidth-2\tabcolsep)}}{\cAlignHack Rapid Mixer Granulator} & \multicolumn{6}{p{\dimexpr(.55\linewidth-2\tabcolsep)}}{\cAlignHack Fluidized Bed Granulator}\\
\rowcolor{kwdboxcolor}\cAlignHack S.no & \cAlignHack Ingredients & \cAlignHack F1 \mbox{}\protect\newline (mg) & \cAlignHack F2 \mbox{}\protect\newline (mg) & \cAlignHack F3 \mbox{}\protect\newline (mg) & \cAlignHack F4 \mbox{}\protect\newline (mg) & \cAlignHack F5 \mbox{}\protect\newline (mg) & \cAlignHack F6 \mbox{}\protect\newline (mg) & \cAlignHack F7 \mbox{}\protect\newline (mg) & \cAlignHack F8 \mbox{}\protect\newline (mg) & \cAlignHack F9 \mbox{}\protect\newline (mg)\\
\tblmidrule 
\multicolumn{3}{p{\dimexpr(.28060000000000002\linewidth-2\tabcolsep)}}{\cAlignHack \textbf{Intragranular}} &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack \\
\cAlignHack 1 &
  \cAlignHack Edoxaban tosylate &
  \cAlignHack 80.82 &
  \cAlignHack 80.82 &
  \cAlignHack 80.82 &
  \cAlignHack 80.82 &
  \cAlignHack 80.82 &
  \cAlignHack 80.82 &
  \cAlignHack 80.82 &
  \cAlignHack 80.82 &
  \cAlignHack 80.82\\
\cAlignHack 2 &
  \cAlignHack Microcryst-       alline cellulose &
  \cAlignHack 198.68 &
  \cAlignHack 202.68 &
  \cAlignHack 194.68 &
  \cAlignHack 198.68 &
  \cAlignHack 202.68 &
  \cAlignHack 194.68 &
  \cAlignHack 198.68 &
  \cAlignHack 202.68 &
  \cAlignHack 194.68\\
\cAlignHack 3 &
  \cAlignHack Pregelatin-          ized starch &
  \cAlignHack 84 &
  \cAlignHack 84 &
  \cAlignHack 84 &
  \cAlignHack 84 &
  \cAlignHack 84 &
  \cAlignHack 84 &
  \cAlignHack 84 &
  \cAlignHack 84 &
  \cAlignHack 84\\
\cAlignHack 4 &
  \cAlignHack Crospovidone &
  \cAlignHack 11.5 &
  \cAlignHack 11.5 &
  \cAlignHack 11.5 &
  \cAlignHack 11.5 &
  \cAlignHack 11.5 &
  \cAlignHack 11.5 &
  \cAlignHack 11.5 &
  \cAlignHack 11.5 &
  \cAlignHack 11.5\\
\multicolumn{3}{p{\dimexpr(.28060000000000002\linewidth-2\tabcolsep)}}{\cAlignHack \textbf{Binder solution}} &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack \\
\cAlignHack 5 &
  \cAlignHack HPC-L Nippon Soda &
  \cAlignHack 12 &
  \cAlignHack 8 &
  \cAlignHack 16 &
  \cAlignHack 12 &
  \cAlignHack 8 &
  \cAlignHack 16 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
\cAlignHack 6 &
  \cAlignHack Hydroxypro-          pyl cellulose LF (Klucel LF) &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack 12 &
  \cAlignHack 8 &
  \cAlignHack 16\\
\cAlignHack 7 &
  \cAlignHack Purified water &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s\\
\multicolumn{3}{p{\dimexpr(.28060000000000002\linewidth-2\tabcolsep)}}{\cAlignHack \textbf{Extra granular}} &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack \\
\cAlignHack 8 &
  \cAlignHack Crospovidone &
  \cAlignHack 7 &
  \cAlignHack 7 &
  \cAlignHack 7 &
  \cAlignHack 7 &
  \cAlignHack 7 &
  \cAlignHack 7 &
  \cAlignHack 7 &
  \cAlignHack 7 &
  \cAlignHack 7\\
\multicolumn{3}{p{\dimexpr(.28060000000000002\linewidth-2\tabcolsep)}}{\cAlignHack \textbf{Lubrication}} &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack  &
  \cAlignHack \\
\cAlignHack 9 &
  \cAlignHack Magnesium stearate &
  \cAlignHack 6 &
  \cAlignHack 6 &
  \cAlignHack 6 &
  \cAlignHack 6 &
  \cAlignHack 6 &
  \cAlignHack 6 &
  \cAlignHack 6 &
  \cAlignHack 6 &
  \cAlignHack 6\\
\multicolumn{2}{p{\dimexpr(.1775\linewidth-2\tabcolsep)}}{\cAlignHack \textbf{Core tablet weight}} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400} &
  \cAlignHack \textbf{400}\\
\cAlignHack 10 &
  \cAlignHack Opadry yellow &
  \cAlignHack 16 &
  \cAlignHack 16 &
  \cAlignHack 16 &
  \cAlignHack 16 &
  \cAlignHack 16 &
  \cAlignHack 16 &
  \cAlignHack 16 &
  \cAlignHack 16 &
  \cAlignHack 16\\
\cAlignHack 11 &
  \cAlignHack Purified water &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s &
  \cAlignHack q.s\\
\multicolumn{2}{p{\dimexpr(.1775\linewidth-2\tabcolsep)}}{\cAlignHack \textbf{Coated tablet weight}} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416} &
  \cAlignHack \textbf{416}\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {In-Process Parameters of FBP} }
\label{tw-0356e16b94a0}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.32870000000000005\linewidth-2\tabcolsep}p{\dimexpr.10279999999999998\linewidth-2\tabcolsep}p{\dimexpr.09889999999999999\linewidth-2\tabcolsep}p{\dimexpr.11560000000000002\linewidth-2\tabcolsep}p{\dimexpr.1208\linewidth-2\tabcolsep}p{\dimexpr.1271\linewidth-2\tabcolsep}p{\dimexpr.1061\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack  & \multicolumn{6}{p{\dimexpr(.6713\linewidth-2\tabcolsep)}}{\cAlignHack In-Process Parameters During Fluid Bed Granulation}\\
\rowcolor{kwdboxcolor}Parameter & \cAlignHack  & \cAlignHack  & \multicolumn{2}{p{\dimexpr(.2364\linewidth-2\tabcolsep)}}{\cAlignHack Time (Clock)} & \cAlignHack  & \cAlignHack \\
\rowcolor{kwdboxcolor} & \cAlignHack 14.00 & \cAlignHack 14.15 & \cAlignHack 14.30 & \cAlignHack 15.00 & \cAlignHack 15.15 & \cAlignHack 15.30\\
\tblmidrule 
Blower Speed &
  \cAlignHack 25 &
  \cAlignHack 30 &
  \cAlignHack 38 &
  \cAlignHack 50 &
  \cAlignHack 40 &
  \cAlignHack 25\\
Blower CFM &
  \cAlignHack 38 &
  \cAlignHack 42 &
  \cAlignHack 56 &
  \cAlignHack 67 &
  \cAlignHack 54 &
  \cAlignHack 40\\
Inlet Temperature (\ensuremath{^{0}}C) &
  \cAlignHack 60 &
  \cAlignHack 65 &
  \cAlignHack 70 &
  \cAlignHack 70 &
  \cAlignHack 50 &
  \cAlignHack 50\\
Bed Temperature (\ensuremath{^{0}}C) &
  \cAlignHack 35 &
  \cAlignHack 34 &
  \cAlignHack 35 &
  \cAlignHack 35 &
  \cAlignHack 40 &
  \cAlignHack 51\\
Product Temperature (\ensuremath{^{0}}C) &
  \cAlignHack 35 &
  \cAlignHack 34 &
  \cAlignHack 34 &
  \cAlignHack 35 &
  \cAlignHack 39 &
  \cAlignHack 50\\
Exhaust Temperature (\ensuremath{^{0}}C) &
  \cAlignHack 33 &
  \cAlignHack 33 &
  \cAlignHack 32 &
  \cAlignHack 33 &
  \cAlignHack 36 &
  \cAlignHack 46\\
Bag Shaking Interval (Min.) &
  \cAlignHack 5 &
  \cAlignHack 5 &
  \cAlignHack 5 &
  \cAlignHack 5 &
  \cAlignHack 5 &
  \cAlignHack 5\\
Bag Shaking Strokes (No) &
  \cAlignHack 3 &
  \cAlignHack 3 &
  \cAlignHack 3 &
  \cAlignHack 3 &
  \cAlignHack 3 &
  \cAlignHack 3\\
Pump Speed (RPM) &
  \cAlignHack 5 &
  \cAlignHack 10 &
  \cAlignHack 12 &
  \cAlignHack 20 &
  \cAlignHack 0 &
  \cAlignHack 0\\
Main Air Pressure (BAR) &
  \cAlignHack 5.2 &
  \cAlignHack 5.3 &
  \cAlignHack 5.3 &
  \cAlignHack 5.2 &
  \cAlignHack 5.3 &
  \cAlignHack 5.2\\
Atomization Air Pressure (BAR) &
  \cAlignHack 0.96 &
  \cAlignHack 0.96 &
  \cAlignHack 0.96 &
  \cAlignHack 0.96 &
  \cAlignHack 0 &
  \cAlignHack 0\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Compression Punch Parameters} }
\label{tw-cf10ba83a3c9}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.50\linewidth-2\tabcolsep}p{\dimexpr.50\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\multicolumn{2}{p{\dimexpr(1\linewidth-2\tabcolsep)}}{\cAlignHack Punch Parameters}\\
\tblmidrule 
\cAlignHack Punch diameter &
  \cAlignHack 10.60mm\\
\cAlignHack Punch Shape &
  \cAlignHack Round shape\\
\cAlignHack Upper punch &
  \cAlignHack Embossed with`ED60'\\
\cAlignHack Lower punch &
  \cAlignHack Embossed with '888.'\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Coating Parameters} }
\label{tw-ac3097150ef5}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.49849999999999994\linewidth-2\tabcolsep}p{\dimexpr.21090000000000003\linewidth-2\tabcolsep}p{\dimexpr.2906\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Parameter  & \cAlignHack Set  & \cAlignHack Actual \\
\tblmidrule 
\cAlignHack Inlet Temperature(\ensuremath{^{0}}C) &
  \cAlignHack 58 &
  \cAlignHack 56-63\\
\cAlignHack Product Temperature(\ensuremath{^{0}}C) &
  \cAlignHack 45 &
  \cAlignHack 40-44\\
\cAlignHack Exhaust Temperature(\ensuremath{^{0}}C) &
  \cAlignHack 45 &
  \cAlignHack 40-44\\
\cAlignHack Inlet Blower &
  \cAlignHack 600 &
  \cAlignHack 575\\
\cAlignHack Exhaust Blower &
  \cAlignHack 550 &
  \cAlignHack 515\\
\cAlignHack Pan RPM &
  \cAlignHack 2-7 &
  \cAlignHack 1-6\\
\cAlignHack Spray RPM &
  \cAlignHack 1-3 &
  \cAlignHack 1-3\\
\cAlignHack Atomization Air pressure &
  \cAlignHack 0.25 &
  \cAlignHack 0.25\\
\cAlignHack Fan Air &
  \cAlignHack 0.2 &
  \cAlignHack 0.2\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Operating Procedure} }
\label{tw-851f426bdd1e}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.4371\linewidth-2\tabcolsep}p{\dimexpr.5629\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Parameters & \cAlignHack Specifications\\
\tblmidrule 
\cAlignHack Column details \& Description &
  \cAlignHack Zorbax eclipse XDB-C18 250\ensuremath{\times}4.6 mm, 5\ensuremath{\mu}m\\
\cAlignHack Flow rate &
  \cAlignHack 1.2mL /min\\
\cAlignHack Wavelength &
  \cAlignHack 260nm\\
\cAlignHack Colum temperature &
  \cAlignHack 40\ensuremath{^\circ}C\\
\cAlignHack Injection Volume &
  \cAlignHack 10\ensuremath{\mu}L\\
\cAlignHack Run Time &
  \cAlignHack 10 minutes\\
\cAlignHack Mode of Elution &
  \cAlignHack Isocratic\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Inject the Sample as per the Sequence Below} }
\label{tw-1714dbbecb3e}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.5697\linewidth-2\tabcolsep}p{\dimexpr.4303\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Sample ID & \cAlignHack No. of Injections\\
\tblmidrule 
\cAlignHack Blank for baseline check &
  \cAlignHack 1\\
\cAlignHack Check Standard (Standard-1) &
  \cAlignHack 1\\
\cAlignHack Standard-2 &
  \cAlignHack 5\\
\cAlignHack Sample(s) &
  \cAlignHack 2\\
\cAlignHack Bracketing standard (after every 6 sample injections) &
  \cAlignHack 1\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {System Suitability} }
\label{tw-da13d0297007}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.6394\linewidth-2\tabcolsep}p{\dimexpr.3606\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Parameter & \cAlignHack Criteria\\
\tblmidrule 
\cAlignHack  Retention Time &
  \cAlignHack About 3.5 mins\\
\cAlignHack  \%RSD for five replicate injections of standard-2 &
  \cAlignHack NMT-2.0\\
\cAlignHack Column Efficiency of Edoxaban standard -2 &
  \cAlignHack NMT 2000\\
\cAlignHack Tailing factor of edoxaban in standard-2 &
  \cAlignHack NMT 2.0\\
\cAlignHack Similarity factor between standard-1 and standard-2 &
  \cAlignHack 0.98-1.02\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Flow Properties of Edoxaban (API)} }
\label{tw-b6f70b606257}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1784\linewidth-2\tabcolsep}p{\dimexpr.2216\linewidth-2\tabcolsep}p{\dimexpr.1668\linewidth-2\tabcolsep}p{\dimexpr.20990000000000002\linewidth-2\tabcolsep}p{\dimexpr.22330000000000002\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Bulk Density & \cAlignHack Tapped Density & \cAlignHack Carr's Index & \cAlignHack Hausner's Ratio & \cAlignHack Angle of Repose\\
\tblmidrule 
\cAlignHack 0.2214 g/cc &
  \cAlignHack 0.3073 g/cc &
  \cAlignHack 27.9411\% &
  \cAlignHack 1.3877 &
  \cAlignHack Not passed from the funnel\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Edoxaban Tosylate - Excipients Compatibility Study Results at Initial} }
\label{tw-3fdadf88b5b9}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.153\linewidth-2\tabcolsep}p{\dimexpr.0723\linewidth-2\tabcolsep}p{\dimexpr.09779999999999998\linewidth-2\tabcolsep}p{\dimexpr.09850000000000001\linewidth-2\tabcolsep}p{\dimexpr.0991\linewidth-2\tabcolsep}p{\dimexpr.0967\linewidth-2\tabcolsep}p{\dimexpr.1017\linewidth-2\tabcolsep}p{\dimexpr.0975\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}p{\dimexpr.0834\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Condition  \mbox{}\protect\newline  & API   & API +  MCC 101  & API +  Pregelatinized starch & API + HPC-L  & API + Magnesium stearate  & API +  Opadry yellow  & API + Crospovidone  & API + HPC(Nip-    pon soda) & API + Mixture of excipients\\
\tblmidrule 
Unknown                @0.58 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  0.01\\
Unknown                @0.92 &
  ND &
  ND &
  0.01 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
ADCCPO@0.92 &
  0.01 &
  0.01 &
  0.03 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
   ND  &
  0.01\\
DCBCPO@2.18 &
  0.02 &
  2.19 &
   ND &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02\\
TCPAODCC            @2.03 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown                @0.94 &
  ND &
  0.01 &
  ND &
   ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @0.98 &
  0.03 &
  0.03 &
  ND &
  0.03 &
  0.03 &
  0.03 &
  0.05 &
  0.03 &
  0.05\\
Unknown @1.05 &
  0.02 &
  0.06 &
  0.02 &
  0.04 &
  0.06 &
  0.05 &
  0.02 &
  0.04 &
  0.02\\
Unknown @1.07 &
  0.03 &
  0.04 &
  0.03 &
  0.03 &
  0.04 &
  0.04 &
  0.05 &
  0.03 &
  0.03\\
Unknown @1.08 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @1.12 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  ND\\
Unknown @1.19 &
  ND &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  0.01 &
  ND  &
  0.01\\
Unknown @1.21 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.04 &
  0.02 &
  0.02\\
Unknown @1.24 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @1.25 &
  ND &
  ND &
  ND  &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  0.01\\
Unknown @1.40 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  ND\\
Unknown @1.42 &
  0.08 &
  0.08 &
  0.08 &
  0.08 &
  0.08 &
  0.07 &
  0.05 &
  0.08 &
  0.07\\
Unknown @1.84 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @1.52 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @2.40 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @2.47 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @3.07 &
  0.04 &
  0.04 &
  0.05 &
  0.04 &
  0.04 &
  0.04 &
  0.04 &
  0.05 &
  0.04\\
Total impurities &
  0.25 &
  0.31 &
  0.26 &
  0.27 &
  0.31 &
  0.28 &
  0.33 &
  0.27 &
  0.29\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Edoxaban Tosylate - Excipients Compatibility Study Results at 40{\textdegree}C/75\%RH, Four Weeks Open} }
\label{tw-cc69095f06fb}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1779\linewidth-2\tabcolsep}p{\dimexpr.0852\linewidth-2\tabcolsep}p{\dimexpr.09329999999999998\linewidth-2\tabcolsep}p{\dimexpr.0934\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}p{\dimexpr.0925\linewidth-2\tabcolsep}p{\dimexpr.0834\linewidth-2\tabcolsep}p{\dimexpr.0892\linewidth-2\tabcolsep}p{\dimexpr.0909\linewidth-2\tabcolsep}p{\dimexpr.0942\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Condition  \mbox{}\protect\newline Impurities & API  & API +  \mbox{}\protect\newline MCC 101 & API +  \mbox{}\protect\newline Pregela- tinized starch & API + HPC-L & API + Magnesium stearate & API +  \mbox{}\protect\newline Opadry yellow & API + Crospo-vidone & API + HPC(Ni- ppon soda) & API + Mixture of excipients\\
\tblmidrule 
Unknown                       @0.24 &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown                       @0.58 &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  0.01 &
  ND &
  ND &
  0.01\\
Unknown                       @0.92 &
  ND &
  ND &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  ND &
  ND\\
ADCCPO                        @0.92 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01\\
DCBCPO                        @2.18 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  ND \\
TCPAODCC                    @2.03 &
  ND &
  ND &
  ND &
  ND &
  0.03 &
  0.01 &
  ND &
  ND &
  ND\\
Unknown                       @0.94 &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  0.01 &
  0.01 &
  0.01 &
  ND\\
Unknown @0.98 &
  0.03 &
  0.03 &
  0.03 &
  0.03 &
  0.03 &
  0.03 &
  0.03 &
  0.03 &
  0.06\\
Unknown @1.05 &
  0.05 &
  0.05 &
  0.02 &
  0.06 &
  0.06 &
  0.05 &
  0.06 &
  0.05 &
  0.02\\
Unknown @1.07 &
  0.04 &
  0.04 &
  0.03 &
  0.04 &
  0.04 &
  0.04 &
  0.04 &
  0.04 &
  0.04\\
Unknown @1.12 &
  ND &
  ND &
  ND &
  ND &
  ND &
  0.01 &
  ND &
  ND &
  ND\\
Unknown @1.19 &
  ND &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.01 &
  0.02\\
Unknown @1.21 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02 &
  0.02\\
Unknown @1.24 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND\\
Unknown @1.25 &
  ND &
  0.01 &
  0.01 &
  ND &
  ND &
  ND &
  0 &
  0.01 &
  0.01\\
Unknown @1.40 &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  ND &
  0.01\\
Unknown @1.42 &
  0.08 &
  0.08 &
  0.08 &
  0.09 &
  0.08 &
  0.08 &
  0.08 &
  0.08 &
  0.11\\
Unknown @1.84 &
  ND &
  0.02 &
  ND &
  ND &
  0.03 &
  0.03 &
  ND &
  0.02 &
  ND\\
Unknown @3.07 &
  0.06 &
  0.05 &
  0.07 &
  0.06 &
  0.07 &
   ND &
  0.07 &
  0.07 &
  0.07\\
Total impurities &
  0.31 &
  0.34 &
  0.3 &
  0.37 &
  0.4 &
  0.34 &
  0.35 &
  0.37 &
  0.4\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Pre-Compression Specifications for Batches of Edoxaban Tosylate} }
\label{tw-3f81089182f7}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.16\linewidth-2\tabcolsep}p{\dimexpr.1863\linewidth-2\tabcolsep}p{\dimexpr.18900000000000002\linewidth-2\tabcolsep}p{\dimexpr.16979999999999997\linewidth-2\tabcolsep}p{\dimexpr.1406\linewidth-2\tabcolsep}p{\dimexpr.1543\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Formulation Code & \cAlignHack Bulk Density (gm/ml) & \cAlignHack Tapped Density (gm/ml) & \cAlignHack Compressibility Index (\%) & \cAlignHack Hausner's Ratio & \cAlignHack Angle of Repose\\
\tblmidrule 
\cAlignHack F1 &
  \cAlignHack 0.447\ensuremath{\pm}0.006 &
  \cAlignHack 0.593\ensuremath{\pm}0.006 &
  \cAlignHack 24.62\ensuremath{\pm}1.65 &
  \cAlignHack 1.32\ensuremath{\pm}0.88 &
  \cAlignHack 26.43\ensuremath{\pm}0.681\\
\cAlignHack F2 &
  \cAlignHack 0.468\ensuremath{\pm}0.002 &
  \cAlignHack 0.604\ensuremath{\pm}0.003 &
  \cAlignHack 22.51\ensuremath{\pm}1.46 &
  \cAlignHack 1.29\ensuremath{\pm}0.51 &
  \cAlignHack 25.35\ensuremath{\pm}0.450\\
\cAlignHack F3 &
  \cAlignHack 0.472\ensuremath{\pm}0.003 &
  \cAlignHack 0.528\ensuremath{\pm}0.007 &
  \cAlignHack 10.6\ensuremath{\pm}1.54 &
  \cAlignHack 1.11\ensuremath{\pm}0.64 &
  \cAlignHack 27.31\ensuremath{\pm}0.486\\
\cAlignHack F4 &
  \cAlignHack 0.463\ensuremath{\pm}0.004 &
  \cAlignHack 0.556\ensuremath{\pm}0.003 &
  \cAlignHack 16.72\ensuremath{\pm}1.34 &
  \cAlignHack 1.20\ensuremath{\pm}0.33 &
  \cAlignHack 24.86\ensuremath{\pm}0.271\\
\cAlignHack F5 &
  \cAlignHack 0.456\ensuremath{\pm}0.002 &
  \cAlignHack 0.574\ensuremath{\pm}0.002 &
  \cAlignHack 20.05\ensuremath{\pm}1.66 &
  \cAlignHack 1.24\ensuremath{\pm}0.26 &
  \cAlignHack 23.12\ensuremath{\pm}0.450\\
\cAlignHack F6 &
  \cAlignHack 0.461\ensuremath{\pm}0.005 &
  \cAlignHack 0.587\ensuremath{\pm}0.005 &
  \cAlignHack 21.46\ensuremath{\pm}1.27 &
  \cAlignHack 1.27\ensuremath{\pm}0.61 &
  \cAlignHack 26.72\ensuremath{\pm}0.632\\
\cAlignHack F7 &
  \cAlignHack 0.484\ensuremath{\pm}0.002 &
  \cAlignHack 0.547\ensuremath{\pm}0.006 &
  \cAlignHack 11.51\ensuremath{\pm}1.89 &
  \cAlignHack 1.13\ensuremath{\pm}0.87 &
  \cAlignHack 24.44\ensuremath{\pm}0.187\\
\cAlignHack F8 &
  \cAlignHack 0.472\ensuremath{\pm}0.003 &
  \cAlignHack 0.528\ensuremath{\pm}0.007 &
  \cAlignHack 10.6\ensuremath{\pm}1.54 &
  \cAlignHack 1.11\ensuremath{\pm}0.64 &
  \cAlignHack 23.37\ensuremath{\pm}0.121\\
\cAlignHack F9 &
  \cAlignHack 0.478\ensuremath{\pm}0.007 &
  \cAlignHack 0.563\ensuremath{\pm}0.004 &
  \cAlignHack 15.01\ensuremath{\pm}1.76 &
  \cAlignHack 1.17\ensuremath{\pm}0.54 &
  \cAlignHack 24.65\ensuremath{\pm} 0.28\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Post-Compression Parameters of Edoxaban Tosylate Tablets} }
\label{tw-067cde6acd6e}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.0939\linewidth-2\tabcolsep}p{\dimexpr.1861\linewidth-2\tabcolsep}p{\dimexpr.14\linewidth-2\tabcolsep}p{\dimexpr.1483\linewidth-2\tabcolsep}p{\dimexpr.14709999999999999\linewidth-2\tabcolsep}p{\dimexpr.1471\linewidth-2\tabcolsep}p{\dimexpr.1375\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Batch & \cAlignHack Hardness \mbox{}\protect\newline (kg/cm\ensuremath{^2}) & \cAlignHack Thickness \mbox{}\protect\newline (mm) & \cAlignHack Weight Variation (\%) & \cAlignHack Friability (\%) & \cAlignHack Disintegration Time (Min) & \cAlignHack Assay  \mbox{}\protect\newline (\%)\\
\tblmidrule 
\cAlignHack F1 &
  \cAlignHack 7.1\ensuremath{\pm}0.13 &
  \cAlignHack 4.75\ensuremath{\pm}0.15 &
  \cAlignHack 398\ensuremath{\pm}0.7 &
  \cAlignHack 0.70\ensuremath{\pm}0.04 &
  \cAlignHack 3.05 &
  \cAlignHack 97.74\\
\cAlignHack F2 &
  \cAlignHack 6.3\ensuremath{\pm}0.22 &
  \cAlignHack 4.70\ensuremath{\pm}0.20 &
  \cAlignHack 400\ensuremath{\pm}0.6 &
  \cAlignHack 0.55\ensuremath{\pm}0.13 &
  \cAlignHack 2.50 &
  \cAlignHack 98.01\\
\cAlignHack F3 &
  \cAlignHack 7\ensuremath{\pm}0.14 &
  \cAlignHack 4.65\ensuremath{\pm}0.17 &
  \cAlignHack 402\ensuremath{\pm}0.4 &
  \cAlignHack 0.62\ensuremath{\pm}0.34 &
  \cAlignHack 2.58 &
  \cAlignHack 102.29\\
\cAlignHack F4 &
  \cAlignHack 6.6\ensuremath{\pm}0.21 &
  \cAlignHack 4.69 \ensuremath{\pm}0.15 &
  \cAlignHack 399\ensuremath{\pm}0.5 &
  \cAlignHack 0.54\ensuremath{\pm}0.27 &
  \cAlignHack 3.10 &
  \cAlignHack 97.70\\
\cAlignHack F5 &
  \cAlignHack 7\ensuremath{\pm}0.30 &
  \cAlignHack 4.75\ensuremath{\pm}0.12 &
  \cAlignHack 398\ensuremath{\pm}0.2 &
  \cAlignHack 0.42\ensuremath{\pm}0.19 &
  \cAlignHack 3.00 &
  \cAlignHack 98.49\\
\cAlignHack F6 &
  \cAlignHack 7.2\ensuremath{\pm}0.11 &
  \cAlignHack 4.68\ensuremath{\pm}0.15 &
  \cAlignHack 405\ensuremath{\pm}0.3 &
  \cAlignHack 0.57\ensuremath{\pm}0.14 &
  \cAlignHack 2.30 &
  \cAlignHack 98.97\\
\cAlignHack F7 &
  \cAlignHack 7.5\ensuremath{\pm}0.13 &
  \cAlignHack 4.67\ensuremath{\pm}0.06 &
  \cAlignHack 397\ensuremath{\pm}0.5 &
  \cAlignHack 0.55\ensuremath{\pm}0.13 &
  \cAlignHack 3.05 &
  \cAlignHack 97.49\\
\cAlignHack F8 &
  \cAlignHack 6.8\ensuremath{\pm}0.24 &
  \cAlignHack 4.67\ensuremath{\pm}0.07 &
  \cAlignHack 401\ensuremath{\pm}0.6 &
  \cAlignHack 0.62\ensuremath{\pm}0.14 &
  \cAlignHack 2.50 &
  \cAlignHack 98.09\\
\cAlignHack F9 &
  \cAlignHack 6.5\ensuremath{\pm}0.32 &
  \cAlignHack 4.65\ensuremath{\pm}0.07 &
  \cAlignHack 398\ensuremath{\pm}0.6 &
  \cAlignHack 0.52\ensuremath{\pm}0.14 &
  \cAlignHack 2.00 &
  \cAlignHack 97.85\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Cumulative Percentage of Drug Release} }
\label{tw-6cb0953f049f}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1821\linewidth-2\tabcolsep}p{\dimexpr.068100000000000005\linewidth-2\tabcolsep}p{\dimexpr.06510000000000002\linewidth-2\tabcolsep}p{\dimexpr.07030000000000001\linewidth-2\tabcolsep}p{\dimexpr.0885\linewidth-2\tabcolsep}p{\dimexpr.06289999999999999\linewidth-2\tabcolsep}p{\dimexpr.093\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.09\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Time (min)  & \cAlignHack F1  & \cAlignHack F2  & \cAlignHack F3  & \cAlignHack F4  & \cAlignHack F5  & \cAlignHack F6  & \cAlignHack F7  & \cAlignHack F8  & \cAlignHack F9  & \cAlignHack Innovator\\
\tblmidrule 
\cAlignHack 0  &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0\\
\cAlignHack 5  &
  \cAlignHack 27 &
  \cAlignHack 42 &
  \cAlignHack 45 &
  \cAlignHack 52 &
  \cAlignHack 56 &
  \cAlignHack 49 &
  \cAlignHack 41 &
  \cAlignHack 58 &
  \cAlignHack 44 &
  \cAlignHack 59\\
\cAlignHack 10  &
  \cAlignHack 48 &
  \cAlignHack 54 &
  \cAlignHack 69 &
  \cAlignHack 79 &
  \cAlignHack 82 &
  \cAlignHack 67 &
  \cAlignHack 73 &
  \cAlignHack 81 &
  \cAlignHack 76 &
  \cAlignHack 83\\
\cAlignHack 15  &
  \cAlignHack 60 &
  \cAlignHack 61 &
  \cAlignHack 73 &
  \cAlignHack 81 &
  \cAlignHack 87 &
  \cAlignHack 69 &
  \cAlignHack 81 &
  \cAlignHack 86 &
  \cAlignHack 82 &
  \cAlignHack 87\\
\cAlignHack 30  &
  \cAlignHack 76 &
  \cAlignHack 75 &
  \cAlignHack 82 &
  \cAlignHack 89 &
  \cAlignHack 90 &
  \cAlignHack 78 &
  \cAlignHack 86 &
  \cAlignHack 92 &
  \cAlignHack 89 &
  \cAlignHack 93\\
\cAlignHack 45  &
  \cAlignHack 82 &
  \cAlignHack 81 &
  \cAlignHack 91 &
  \cAlignHack 91 &
  \cAlignHack 93 &
  \cAlignHack 82 &
  \cAlignHack 93 &
  \cAlignHack 95 &
  \cAlignHack 93 &
  \cAlignHack 96\\
\cAlignHack 60  &
  \cAlignHack 88 &
  \cAlignHack 85 &
  \cAlignHack 93 &
  \cAlignHack 93 &
  \cAlignHack 95 &
  \cAlignHack 89 &
  \cAlignHack 97 &
  \cAlignHack 99 &
  \cAlignHack 95 &
  \cAlignHack 101\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Stability Data of Optimized Formula} }
\label{tw-f003b9d5e638}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.14\linewidth-2\tabcolsep}p{\dimexpr.2905\linewidth-2\tabcolsep}p{\dimexpr.11389999999999997\linewidth-2\tabcolsep}p{\dimexpr.11749999999999998\linewidth-2\tabcolsep}p{\dimexpr.11750000000000002\linewidth-2\tabcolsep}p{\dimexpr.10919999999999998\linewidth-2\tabcolsep}p{\dimexpr.1114\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack  & \multicolumn{3}{p{\dimexpr(.5219\linewidth-2\tabcolsep)}}{\cAlignHack Edoxaban Tablets 60mg} & \cAlignHack  & \cAlignHack  & \cAlignHack \\
\rowcolor{kwdboxcolor}\cAlignHack Test & \cAlignHack Tentative Specification & \cAlignHack Initial & \multicolumn{4}{p{\dimexpr(.4556\linewidth-2\tabcolsep)}}{\cAlignHack 40\ensuremath{^\circ}C/75\%RH}\\
\rowcolor{kwdboxcolor}\cAlignHack  & \cAlignHack  & \cAlignHack  & \cAlignHack 1M & \cAlignHack 2M & \cAlignHack 3M & \cAlignHack 6M\\
\tblmidrule 
\cAlignHack Description  &
  \cAlignHack Yellow color, round shape, biconvex and plain on both sides  &
  \multicolumn{5}{p{\dimexpr(.5694999999999999\linewidth-2\tabcolsep)}}{\cAlignHack Yellow color, round shape, biconvex and straight on both sides}\\
\cAlignHack Assay by HPLC  &
  \cAlignHack 95-105\%  &
  \cAlignHack 101.6 &
  \cAlignHack 99.4 &
  \cAlignHack 100.2 &
  \cAlignHack 101.3 &
  \cAlignHack 102.2\\
\multicolumn{3}{p{\dimexpr(.5444\linewidth-2\tabcolsep)}}{\cAlignHack } &
  \multicolumn{4}{p{\dimexpr(.4556\linewidth-2\tabcolsep)}}{\cAlignHack }\\
\cAlignHack MTHTPCA@0.22  &
  \cAlignHack NMT 0.5\% &
  \cAlignHack 0.01 &
  \cAlignHack 0.08 &
  \cAlignHack 0.08 &
  \cAlignHack 0.03 &
  \cAlignHack 0.02\\
\cAlignHack ADCCPO@0.92  &
  \cAlignHack NMT 0.5\% &
  \cAlignHack 0.02 &
  \cAlignHack 0.02 &
  \cAlignHack 0.01 &
  \cAlignHack 0.01 &
  \cAlignHack 0.01\\
\cAlignHack DCBCPO@2.24  &
  \cAlignHack NMT 0.5\% &
  \cAlignHack 0.08 &
  \cAlignHack 0.03 &
  \cAlignHack 0.03 &
  \cAlignHack 0.03 &
  \cAlignHack 0.03\\
\cAlignHack TCPAODCC@2.29  &
  \cAlignHack NMT 0.5\% &
  \cAlignHack ND &
  \cAlignHack ND &
  \cAlignHack ND &
  \cAlignHack ND &
  \cAlignHack ND\\
\cAlignHack Maximum Unknown  &
  \cAlignHack NMT 0.2\% &
  \cAlignHack 0.07 &
  \cAlignHack 0.08 &
  \cAlignHack 0.08 &
  \cAlignHack 0.08 &
  \cAlignHack 0.08\\
\cAlignHack Total impurities &
  \cAlignHack NMT 2\% &
  \cAlignHack 0.47 &
  \cAlignHack 0.55 &
  \cAlignHack 0.40 &
  \cAlignHack 0.40 &
  \cAlignHack 0.40\\
\multicolumn{1}{p{\dimexpr(.14\linewidth-2\tabcolsep)}}{\multirow{2}{\linewidth}{\cAlignHack Dissolution \mbox{}\protect\newline 60}} &
  \multicolumn{6}{p{\dimexpr(.86\linewidth-2\tabcolsep)}}{\cAlignHack Media: pH 6.0 Phosphate Buffer, Volume - 900 mL, Speed - 50 RPM, Apparatus - Type II (Paddle)}\\
 &
  \cAlignHack Not less than 80\% in 30 minutes  &
  \cAlignHack 99\% &
  \cAlignHack 97\% &
  \cAlignHack 98\% &
  \cAlignHack 96\% &
  \cAlignHack 98\%\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
\textbf{Compressibility Index}

It is measured by tapped density apparatus for 500, 750, and 1250 taps, for which the difference should be less than 2\%. Based on the apparent bulk density and tapped density, the percentage compressibility [Table~\ref{tw-8173c3c3468d}] of the blend was determined using the following formula:

$\style{font-family:'Times New Roman'}{\style{font-size:8px}{\%\;Compressibility\;=\;(Tapped\;density\;-\;Bulk\;Density\;/Tapped\;volume)\;\times\;100}} $

\textbf{Hausner's Ratio}

The proportion between the powders' tapped density and bulk density is known as Hausner's ratio. It indicates the flow properties of the powder [Table~\ref{tw-252747fcd148}].

$\style{font-family:'Times New Roman'}{\style{font-size:8px}{Hausner's\;ratio\;=\;Tapped\;density\;/\;Bulk\;density}} $

\textbf{Drug-Excipient Compatibility Studies}

To perform drug excipient similarity research, the medication is mixed with various excipients to varying degrees and placed in a vial. An elastic plug is then affixed to the vial and securely fastened. Glass containers were used for the studies under Sped conditions (40\ensuremath{^\circ} C 2\ensuremath{^\circ} C/75\% RH 5\% RH) for roughly a month to reach capacity [Table~\ref{tw-0cff6f25aa2e}]. After capacity, the sample was compared and controlled between 2 and 8 degrees Celsius, and the true liquefaction, hardness, and staining were seen \unskip~\cite{1649224:26836497}.

\textbf{HPLC Method}

\textbf{Preparation of Solutions } \textbf{\space }

\textbf{pH 3.5 Buffer Preparation (Mobile phase A)}

Pour 0.96 grams of 1-pentane sulphonic acid into 1 liter of water, thoroughly mix, and then raise pH to 3.5 by adding a diluted phosphoric acid solution. Next, pass the solution through a PVDF membrane filter (0.45 m) \unskip~\cite{1649224:26836502,1649224:26836507}.

\textbf{Mobile Phase-B}

100\% Acetonitrile.

\textbf{Diluent}

Acetonitrile and water combined at a 50:50 ratio. 

\textbf{Standard Preparation}

\textbf{Prepare a Standard Stock Solution Containing 0.2mg/mL of Edoxaban}

Weigh accurately and transfer 27mg of Edoxaban standard into a 100 mL volumetric flask. Add 50mL of diluent. Sonicate to dissolve and mix thoroughly and dilute to the desired volume. 

\textbf{Prepare a Standard Solution Containing 0.001mg/mL of Edoxaban}

Further pipette out 5mL of standard solution into 100mLvolumetric flask, mix thoroughly and dilute to the desired volume. From this solution, pipette out 1ml and transfer into a 10ml flask, mix thoroughly, and cut to the desired volume.

\textbf{Preparation of Placebo}

Add 35 mL of diluent, accurately weigh and put a placebo into a 50 mL volumetric flask equivalent to 25 mg of Edoxaban, and Sonicate for 15 minutes with intermittent shaking. Cool the flask to room temperature after removing the solution from the sonicator, then add diluent to make the capacity 50mL. The sample should be centrifuged at 4000 RPM for 10 minutes. Fill an HPLC vial with the supernatant liquid and inject it. 

\textbf{Sample Preparation}

Accurately weigh a sample equivalent to 25mg of Edoxaban into 50mL of volumetric flask and add 35mL of diluent and Sonicate for 15 minutes with intermediate shaking. Centrifuge the sample for 10 minutes at 4000 RPM. Transfer the supernatant liquid into an HPLC vial and inject it into HPLC. Remove the solution from the sonicator, cool the flask to room temperature, and make up the volume of 50mL with diluent.

\textbf{Operating Procedure}

Equilibrate the instrument with the following chromatographic parameters [Table~\ref{tw-35971e6c411c}, Table~\ref{tw-9ceb25b6ce98}, Table~\ref{tw-8e0ad901da3b}, Table~\ref{tw-c694c1f3349d} and Table~\ref{tw-418c28992ee5}].

\textbf{The Formulation Composition of Edoxaban Tosylate Immediate-Release Tablets }

Formulation of immediate-release edoxaban tosylate 60mg tablets was carried out by fluidized bed granulation technique \unskip~\cite{1649224:26836503}  [Table~\ref{tw-86246957924d}].

\textbf{The Manufacturing Procedure of Immediate-Release Edoxaban Tosylate Tablets }

\textbf{Dispensing}

Edoxaban tosylate monohydrate, microcrystalline cellulose 101, Pregelatinized starch Crospovidone and binder are weighed in required quantities \unskip~\cite{1649224:26836506}.

\textbf{Sifting}

Sift edoxaban tosylate, microcrystalline cellulose 101, pregelatinized starch, and Crospovidone through the \#30 sieve.

\textbf{Binder Preparation}

Take the required quantity of purified water in a beaker, add the binder while stirring, and keep going until the binder completely dissolves. 

\textbf{Wet Granulation by Rapid Mixer Granulator (F1-F3)}

Sifted Edoxaban Tosylate, Microcrystalline Cellulose, Pregelatinized starch, and Crospovidone loaded to the RMG bowl and dry mix it for 10min at speed with impeller slow (100 RPM) and Chopper OFF. Add binder solution within 2 min at speed with impeller slow (100 RPM) and chopper OFF. Continue Kneading for 30sec at a rate of impeller fast (200 RPM) and chopper fast (2000 RPM)

\textbf{Drying}

Transfer wet Mass from RMG bowl to Fluidized Bed Dryer and dry it for 30 min at 60\ensuremath{^\circ}C until required LOD achieves.

\textbf{Fluid Bed Granulation: (Top Spray Granulation) }

Sifted Edoxaban Tosylate, Microcrystalline Cellulose, Pregelatinized starch, and Crospovidone loaded to the FBP bowl and mixed for 3min at 25\% of blower speed followed by binder solution spraying and drying as indicated parameters in the Table~\ref{tw-0356e16b94a0}.

\textbf{Drying -} \textbf{25 Min}

LOD: 5.70\% w/w at 105\ensuremath{^{0}}C

\textbf{Milling /Sizing}

The dried granules are passed through a cone mill fitted with a 0.5mm screen, and these milled granules are passed through a \# 20 sieve.

\textbf{Blending}

Dispense Crospovidone and magnesium stearate as per the Weight of dried granules.

\textbf{Pre-lubrication}

Add \#40 sifted extra granular Crospovidone and sized granules to the Octagonal Blender and blend for 05 min. At 08 rpm.

\textbf{Lubrication}

Magnesium Stearate \#60 sifting is added to the blender, and the process takes 05 minutes at a speed of 8 rpm [Table~\ref{tw-cf10ba83a3c9}]. 

\textbf{Coating Dispersion Preparation}

Opadry yellow dispersed in purified water under continuous stirring for 45 min.

\textbf{Coating}

Core tablets are loaded in a coating pan and pre-warmed for 10 minutes at 37\ensuremath{^\circ}C. The coating solution started on pre-warmed tablets up to weight build-up of 4\%weight by using the following parameters [Table~\ref{tw-ac3097150ef5}]. After completion of coating, tablets are dry at 35\ensuremath{^\circ}C-40\ensuremath{^\circ}C temperature for 15 minutes \unskip~\cite{1649224:26836494}.

\textbf{Evaluation of Edoxaban Tosylate Tablets}

\textbf{Post-Compression Parameters}

The tablets were examined for in-progress and finished item quality control tests, including appearance, aspects (width and thickness), weight variety, hardness, friability, assay, and drug content \unskip~\cite{1649224:26836495,1649224:26836505,1649224:26836504}. 

\textbf{Appearance}

The tablet should be free of cracks, problems, pinholes, and other issues. The tablet's color and cleanliness should be consistent over its entire surface. The pills' outside should have a smooth surface.

\textbf{Thickness}

For the 20 pre-gauged tablets of each group utilizing a computerized Vernier scale, the standard in mm is still up in the air. The tablet thickness should not exceed the average by more than 5\%. 

\textbf{Weight Variation}

Twenty pills were chosen randomly from a group and independently weighed. On the off chance that no medicine contrasts by more than one, the tablets meet the USP details, while perhaps not all tablets are outside as far as is practicable. 

\textbf{Hardness Test}

Hardness (polar pounding strength) is a force that can be used to break a tablet. A tablet's solidity can be inferred by how hard it is. The tablet should withstand mechanical pressure while being handled and transported. With different tablet brands and different types, the degree of hardness varies. Ten tablets were tested for hardness, and the average hardness was established. The unit is KP or kg/cm\ensuremath{^{2}}. 

\textbf{Friability Test}

As a result of the surface's evacuation of microscopic particles, friability is the absence of the Weight of the tablet in the holder or bundle. This is a test for in-process quality control. It is done to ensure that tablets can endure shocks during handling, care, transit, and shipment. The Roche Friabilator was used to gauge how friable the pills were. It is turning at a speed of 25 rpm. The tablets are subject to rolling in the friabilator due to a sudden drop inside the friabilator's office. The tablets are taken from the stabilator after 4 minutes, and the undamaged tablets are once more weighed together. 1.0\% is the allowable friability cap.

The percentage friability was measured by using the following formula:

$\style{font-family:'Times New Roman'}{\style{font-size:8px}{\%\;F\;=\;\{1-(W\;/\;Wo)\}\;x\;100}} $

Where,

\%F = friability in percentage;

Wo = Initial Weight of tablet;

W = Weight of tablets after the revolution.

\textbf{Disintegration Time}

The tablet's time to separate into smaller particles is known as the degradation time. The disintegration test apparatus includes a bushel rack along with six glass containers that are each 7.75 cm long and 2.15 mm in diameter and whose lowest portion has a filter with a \#10 cross-section. 28{\textendash}32 times per second, the bin is raised and lowered in a 900 ml container preserved at 37 \ensuremath{^\circ}C. Each tablet is placed in each of the cylinders, and the deteriorating season was defined as the time it took for all of the tablet pieces to travel through the lattice (\# 10). 

\textbf{Dissolution Studies}

\textbf{Method}

The dissolution test was completed in USP Device Type II (paddle) with pH 6.0 phosphate support as the disintegration medium. The examples were drawn at 5, 10, 15, 20 30, min. New medium volumes were supplanted with the removed book to keep up with the sink conditions. 

\textbf{Dissolution Parameters}

Dissolution Apparatus: USP Apparatus Type II (Paddle)

Dissolution Medium: pH 6.0 Phosphate buffer

Volume: 900 ml

Temperature : 37 \ensuremath{\pm} 2\ensuremath{^\circ} C

 RPM: 50 

Sampling Intervals (min): 5, 10, 15, 20, 30, and 45 min

\textbf{Assay of Edoxaban Tosylate Tablets by HPLC}

\textbf{Preparation of Solutions}

\textbf{pH 3.5 Buffer Preparation}

Pour 0.96 grams of 1-pentane sulphonic acid into 1 liter of water, thoroughly mix, and then raise pH to 3.5 by adding a diluted phosphoric acid solution. Next, pass the solution through a PVDF membrane filter (0.45 m). 

\textbf{Mobile Phase Preparation}

Acetonitrile in a 70:30\% v/v mix as a buffer. 

\textbf{Diluent}

50/50 acetonitrile and water should be combined. 

\textbf{Preparation of Standard}

Transfer 81 mg of standard edoxaban tosylate precisely weighed into a 50 ml volumetric flask. Add 35mL of the diluent, sonicate it to dissolve it, then add the remaining diluent and thoroughly combine. Pipette 5 mL of the standard stock solution into a 100 mL volumetric flask, add diluent to fill the flask to volume and then mix thoroughly. 

\textbf{Sample Preparation}

Weigh the tablet, carefully transfer it to the designated volumetric flask, and then pour 70\% diluent into it. Thirty minutes of intermediate shaking while sonicating. Take the flask out and let it cool to room temperature. Then combine the diluent to make up the remaining volume. The solution should be centrifuged at 4000 RPM for 10 minutes [Table~\ref{tw-851f426bdd1e}, Table~\ref{tw-1714dbbecb3e} and Table~\ref{tw-da13d0297007}].

$\style{font-family:'Times New Roman'}{\style{font-size:8px}{\%\;Assay=\frac{Average\;Sample\;Area}{Average\;S\tan dard-2\;Area}\times\frac{Ws}{50}\times\frac5{100}\times\frac{250}{No.of\;tablets\;taken}\times\frac{100}5\times\frac1L\times\frac P{100}\times\frac{548.056}{738.3}\times100}} $

Where,

 P = \%Potency of Edoxaban Tosylate Standard;

 L = Label the amount of Edoxaban Tosylate in mg;

Ws = Weight of the standard-2 taken

\textbf{Stability Study}

Evaluating how temperature and humidity affect a drug's stability is critical. It facilitates data generation for forecasting the product's shelf life and suggested storage settings \unskip~\cite{1649224:26836501}. Following ICH recommendations, optimized instant-release tablets and their final tablet formulation were subjected to accelerated stability testing for a month in a stability chamber at 40 2\ensuremath{^\circ}C and 75 5\% RH. The samples were put into vials, sealed with aluminum caps, and plugged with Bromo butyl rubber.
    
\section{RESULTS AND DISCUSSION}
\textbf{Preformulation Studies}

The flow properties of edoxaban (API) is shown in Table~\ref{tw-b6f70b606257}.

\textbf{Excipients Compatibility Study}

The edoxaban and excipients were compatible for four weeks because the impurities were below acceptable levels [Table~\ref{tw-3fdadf88b5b9}].

\textbf{Excipients Compatibility Study Results at 40{\textdegree}C/75\%RH}

Because the contaminants were found below permitted levels, the edoxaban and excipients were first declared compatible for four weeks [Table~\ref{tw-cc69095f06fb}].

\textbf{Characterization of Tablets}

The values for Hausner's ratio fall in the range of 1.17 to 1.32. The result concluded that the powder blends had good flow properties, which can be used for tablet manufacture. Bulk densities and tapped densities of various formulations were in the range of 0.456 to 0.478 (gm/cc) and 0.528 to 0.604 (gm/cc), respectively [Table~\ref{tw-3f81089182f7}]. The Angle of repose was found in the range of 23\ensuremath{^{0}} to 27\ensuremath{^{0}}.

\textbf{Pre-Compression Specifications}

\textbf{Hardness Test}

The tablets' hardness is between 6.0 and 8.0 kg/cm\ensuremath{^{2}}, notwithstanding their rapid deterioration. The reduced standard deviation values showed that the numerous details' hardness was consistent with the precise method and had a good balance of hardness and mechanical strength [Table~\ref{tw-067cde6acd6e}]. 

\textbf{Friability Test }

The study's findings show that every formulation falls well below the acceptable range (1\%). The values were located inside the boundaries. Tablets have strong mechanical properties as a result [Table~\ref{tw-067cde6acd6e}]. 

\textbf{Weight Variation Test }

All the tablets passed the weight variation test since the weight variation\% ranged from 397.5\% to 401.6\%, within the pharmacopoeial limitations [Table~\ref{tw-067cde6acd6e}]. 

\textbf{Thickness }

The thickness was measured for three tablets from each batch [Table~\ref{tw-067cde6acd6e}]. The outcome revealed that the tablet's average thickness ranges from 4.65 mm to 4.75 mm.

\textbf{Disintegration Time}

All the cores of various formulations quickly dissolved between 2 min to 3 min 10 sec. 

\textbf{Assay}

The assay of different formulations was within 97-102\%.

\textit{\textbf{The In-Vitro}} \textbf{ Drug Release Pattern}

A table displaying the findings of the dissolving profiles for each formulation was F8 had a very short in vitro disintegration time [Table~\ref{tw-6cb0953f049f}]. 99\% of the medication is released according to F8 within 60 minutes of interaction with the dissolving medium [Figure~\ref{f-de8c7855d573}].


\bgroup
\fixFloatSize{images/9e60f76b-845a-4029-a0b1-5dc58809d060-upicture1.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/9e60f76b-845a-4029-a0b1-5dc58809d060-upicture1.png}{\includegraphics{images/9e60f76b-845a-4029-a0b1-5dc58809d060-upicture1.png}}{}
\makeatother 
\caption{\boldmath {\textit{In Vitro} Dissolution Studies For F1-F9 and Innovator}}
\label{f-de8c7855d573}
\end{figure}
\egroup
\textbf{Stability Data } \textbf{\space }

The stability test findings revealed that throughout the first, second, and third months of accelerated condition storage, the release rate of Edoxaban tablets stored at a temperature of 40\ensuremath{^\circ}C and relative humidity of 75\% remained unaltered [Table~\ref{tw-f003b9d5e638}].
    
\section{CONCLUSION }
HPLC studies showed that there was no interaction between drugs and excipients. Core tablets obtained were evaluated for pre-compression and post-compression parameters, all parameters shown within limits. Nine different formulations (F1-F9) of Edoxaban immediate release tablets were prepared using Rapid Mixer Granulation and Fluidized bed granulation method and by changing drug: binder rations. In this in-vitro drug release study, formulation F8 showed 99\% drug release within 60 minutes. The formulation F8 dissolution profile was found comparable to the Reference product. The optimized formula was subjected to stability studies and was found to be stable.
    
\section{ACKNOWLEDGEMENT}
The authors are thankful to the Management \& Principal of Vishnu Institute of pharmaceutical education and research, Narsapur, Medak. 

\textbf{Funding Support}

The authors declare that they have no funding support for this study.

\textbf{Conflict of Interest}

The authors declare that this study has no conflict of interest.
    
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