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\def\citeauthor{~Bathala~Anitha,
              ~Praveen~Kumar~C~H,
              ~Jampani~Susmitha,
              ~Poolla~Ramya~Krishna}
\def\citetitle{Formulation and Evaluation of Prolonged-Release Tablets Containing Solid Dispersions of Rosuvastatin Calcium}
\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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\def\RunningAuthor{Praveen Kumar C H et al.}
\firstPage{180}
\articleType{Original Article}
\receivedDate{10 Aug 2021}
\acceptedDate{26 Aug 2021}
\revisedDate{23 Aug 2021}
\journalVolume{1}
\journalIssue{4}
\journalDoi{fjphs.v1i4.180}
\copyrightYear{2021}
\eISSN{2583-116X}
\journalDoi{fjphs.v1i4.180}
\def\authorCount{4}
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\def\journalTitle{Future Journal of Pharmaceuticals and Health Sciences}

\title{Formulation and Evaluation of Prolonged-Release Tablets Containing Solid Dispersions of Rosuvastatin Calcium}
\author{Bathala~Anitha\textsuperscript{1}\textsuperscript{\href{https://orcid.org/0000-0002-6224-6976}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}},  
            Praveen~Kumar~C~H\textsuperscript{*}\textsuperscript{2}\textsuperscript{\href{https://orcid.org/0000-0001-7027-4515}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}},  
            Jampani~Susmitha\textsuperscript{1}\textsuperscript{\href{https://orcid.org/0000-0002-2002-9631}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}}, 
            Poolla~Ramya~Krishna\textsuperscript{1}\textsuperscript{\href{https://orcid.org/0000-0002-1265-8593}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}}~\\[5pt]{\textsuperscript{1}Ratnam Institute of Pharmacy, Pidathapolur, Pidathapolur (V \& P), Muthukur (M), SPSR Nellore-524346, Andhra Pradesh, India}~\\{\textsuperscript{2}Department of Pharmaceutics, Ratnam Institute of Pharmacy, Pidathapolur (V \& P), Muthukur (M), SPSR Nellore-524346, Andhra Pradesh, India}}

\begin{abstract}
Pharmaceutical Industry is striving hard to improve the dissolution of drugs with limited water solubility. One of the approaches to improve the dissolution rate of poorly soluble drugs is solid dispersion. Hence in the present research, an attempt was made to improve the bioavailability of Rosuvastatin by formulating it as a solid dispersion. The release of Rosuvastatin calcium solid dispersion was prolonged using HPMC. Eudragit L-100 and PEG-6000 were used as carriers. Nine formulations of prolonged-release Rosuvastatin calcium (RS-SD 1 to RS-SD 9) were prepared and evaluated for pre and post formulation studies. Among all the formulations RS SD-3 showed an optimum release profile with 97.5\ensuremath{\pm}3.89 \% indicating it to be the best formulation in the present research. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Rosuvastatin Calcium,\newline Prolonged Release,\newline Solid Dispersion,\newline Solubility,\newline Dissolution etc.
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Praveen~Kumar~C~H~\\ Phone:\ +91 7382456321~\\  Email:\ praveenchembeti@gmail.com
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\section{Introduction}
Rosuvastatin is an HMG-COA reductase inhibitor that lowers the levels of lipids and lipoproteins in the blood. HMG-COA reductase inhibitors competitively inhibit the conversion of 3-hydroxy-3-methyl glutamyl co-enzyme A(HMG CO-A) to mevalonate by the enzyme HMG COA reductase \unskip~\cite{1193017:23025585}. Rosuvastatin is a newer potent (BCS Class II drug) statin with plasma (half-life) of 18-24 hours. Bioavailability was found to be 20\% which may lead to poor therapeutic effectiveness \unskip~\cite{1193017:23025584}. Several conventional methods such as micronization, mucoadhesive microspheres, nanosuspensions, liquisolid compacts \unskip~\cite{1193017:23025594,1193017:23025589}, solid dispersion, microemulsion, and self-emulsifying systems \unskip~\cite{1193017:23025582}, nanocrystals \unskip~\cite{1193017:23025587}, etc. are available to enhance the bioavailability of BCS Class II drugs. Solid dispersion tends to improve the solubility of poorly soluble drugs thereby improving their bioavailability. So, in the present research, an attempt was made to improve the bioavailability of Rosuvastatin calcium by formulating it as a solid dispersion. Drug release was extended with the help of various hydrophilic and hydrophobic polymers like PEG-6000, HPMC E 15, and Eudragit L-100. Hence in the present research prolonged-release solid dispersion of Rosuvastatin was formulated and evaluated. 
    
\section{MATERIALS AND METHODS}
\textbf{Materials}

Rosuvastatin calcium was kindly gifted by Drugs India, Hyderabad. Polyethylene glycol -6000, Eudragit L-100, HPMC E-15, Potassium phosphate monobasic, Lactose, Magnesium stearate, Talc was obtained from New Himalaya Scientific Company, Nellore. All the chemicals used were of analytical grade.

\textbf{Methodology}

Pre-formulation studies were performed for the drug and excipients and drug-excipient interactions were studied using FT-IR spectroscopy and the results were shown in Figure~\ref{f-984c83db1aa2}, Figure~\ref{f-3309e7f9f0aa}, Figure~\ref{f-d6840815d128} and Figure~\ref{f-3bc8effcf248}.


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\caption{\boldmath {FTIR spectra of Rosuvastatin calcium}}
\label{f-984c83db1aa2}
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\egroup

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\caption{\boldmath {FTIR spectra of Eudragit}}
\label{f-3309e7f9f0aa}
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\caption{\boldmath {FTIR Spectra of PEG 6000}}
\label{f-d6840815d128}
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\caption{\boldmath {FTIR Spectra of Rosuvastatin + Polymer Mixture}}
\label{f-3bc8effcf248}
\end{figure}
\egroup
\textbf{Method of Preparation: Rosuvastatin SD}

Rosuvastatin calcium and carrier are taken in different ratios as shown in Table~\ref{tw-0342c7cd470b}  in a china dish and melted on a water bath. Then the mixture is set to cool on an ice bath and air-dried. The obtained solid dispersion is sieved through 60\# \unskip~\cite{1193017:23025593,1193017:23025588}.

\textbf{Estimation of Rosuvastatin in SD by UV Spectrophotometry}

Accurately weighted amount of SD (dose equivalent to 40mg) was dissolved in 0.1M, pH 7.4 buffer solution in 100 ml of the volumetric flask which was previously cleaned and dry. This solution after suitable dilution was measured at 244 nm in UV/Vis spectrophotometer.

\textbf{Method of Preparation: Rosuvastatin SD Prolonged Release Tablets}

Prolonged-release tablets (Rosuvastatin SD dose equivalent to 40mg) of Rosuvastatin were prepared by direct compression method. The composition of prolonged-release tablets is given in Table~\ref{tw-186699cebc47}. HPMC E15 was used as a polymer in all the formulations, magnesium stearate and talc were used as glidant and lubricant \unskip~\cite{1193017:23025583,1193017:23025591}.

The formulations were evaluated for various physicochemical parameters including the angle of repose, bulk density, tapped density, compressibility index, and Hausner's ratio \unskip~\cite{1193017:23025592}. Results were shown in Table~\ref{tw-c156449e1927}.

After compression, the tablets were evaluated for hardness, thickness, friability, weight variation, and in-vitro dissolution studies.

\textbf{Determination of Drug Content}

From each formulation dose equivalent to 40mg was crushed to powder. The crushed powder was transferred into a 100 ml flask and diluted to 100 ml with methanol and stirred magnetically for 1 hr, centrifuged, and filtered. 1 ml of this solution was taken and it was diluted to 100 ml with chloroform and then absorbance was noted at 244 nm using a UV-visible spectrophotometer. Using calibration curve the drug content was determined from the absorbance of tablets. Results were shown in Table~\ref{tw-110435b917a9}\unskip~\cite{1193017:23025590}.

\textbf{\textit{In vitro} drug release study}

Rosuvastatin prolonged-release tablets were determined by using the dissolution test apparatus (Lab India DS8000). The in vitro studies were determined by using 900ml phosphate buffer pH 6.8 at 37\ensuremath{\pm}2\ensuremath{^{o}}C temperature and 50 rpm. Every sample was taken at 1-hour intervals and calculated the absorbance at 244 nm by using the UV visible spectrophotometer \unskip~\cite{1193017:23025586}. Then calculated the cumulative 


\begin{table*}[!htbp]
\caption{\boldmath {Formulation of Rosuvastatin Calcium Solid Dispersion} }
\label{tw-0342c7cd470b}
\centering 
\begin{threeparttable}

\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.22509999999999998\linewidth-2\tabcolsep}p{\dimexpr.26040000000000003\linewidth-2\tabcolsep}p{\dimexpr.2666\linewidth-2\tabcolsep}p{\dimexpr.2479\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack F.Code & \cAlignHack Drug & \cAlignHack Carrier & \cAlignHack Ratio \mbox{}\protect\newline (Drug: Carrier)\\
\tblmidrule 
\cAlignHack RS-SD 1 &
  \cAlignHack Rosuvastatin &
  \cAlignHack Eudragit L 100 &
  \cAlignHack 1:2\\
\cAlignHack RS-SD 2 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack Eudragit L 100  &
  \cAlignHack 1:4\\
\cAlignHack RS-SD 3 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack Eudragit L 100  &
  \cAlignHack 1:6\\
\cAlignHack RS-SD 4 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack PEG - 6000 &
  \cAlignHack 1:2\\
\cAlignHack RS-SD 5 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack PEG - 6000 &
  \cAlignHack 1:4\\
\cAlignHack RS-SD 6 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack PEG - 6000 &
  \cAlignHack 1:6\\
\cAlignHack RS-SD 7 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack Eudragit: PEG &
  \cAlignHack 1:1:1\\
\cAlignHack RS-SD 8 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack Eudragit: PEG &
  \cAlignHack 1:2:2\\
\cAlignHack RS-SD 9 &
  \cAlignHack Rosuvastatin  &
  \cAlignHack Eudragit: PEG &
  \cAlignHack 1:3:3\\
\tblbottomrule 
\end{tabulary}\par 
\begin{tablenotes}\footnotesize 
    
\item{RS-SD: Rosuvastatin Solid Dispersion, PEG: Poly Ethylene Glycol}
\end{tablenotes}
\end{threeparttable}

\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Percentage Yield for Rosuvastatin Calcium Solid Dispersion} }
\label{tw-186699cebc47}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.18780000000000005\linewidth-2\tabcolsep}p{\dimexpr.28119999999999994\linewidth-2\tabcolsep}p{\dimexpr.25610000000000003\linewidth-2\tabcolsep}p{\dimexpr.27490000000000002\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack F-Code & \cAlignHack Theoretical Yield \mbox{}\protect\newline  (in gm) & \cAlignHack Practical yield \mbox{}\protect\newline  (in gm) & \cAlignHack Percentage yield \mbox{}\protect\newline  (in gm)\\
\tblmidrule 
\cAlignHack RS SD-1 &
  \cAlignHack 3 &
  \cAlignHack 2.50 &
  \cAlignHack 83.3\\
\cAlignHack RS SD-2 &
  \cAlignHack 5 &
  \cAlignHack 4.04 &
  \cAlignHack 80.8\\
\cAlignHack RS SD-3 &
  \cAlignHack 7 &
  \cAlignHack 4.714 &
  \cAlignHack 67.3\\
\cAlignHack RS SD-4 &
  \cAlignHack 3 &
  \cAlignHack 2.314 &
  \cAlignHack 43.8\\
\cAlignHack RS SD-5 &
  \cAlignHack 5 &
  \cAlignHack 2.74 &
  \cAlignHack 54.8\\
\cAlignHack RS SD-6 &
  \cAlignHack 7 &
  \cAlignHack 4.32 &
  \cAlignHack 61.7\\
\cAlignHack RS SD-7 &
  \cAlignHack 3 &
  \cAlignHack 2.705 &
  \cAlignHack 90.1\\
\cAlignHack RS SD-8 &
  \cAlignHack 5 &
  \cAlignHack 3.994 &
  \cAlignHack 79.8\\
\cAlignHack RS SD-9 &
  \cAlignHack 7 &
  \cAlignHack 1.11 &
  \cAlignHack 15.8\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Formulation of Rosuvastatin SD Prolonged Release Tablets} }
\label{tw-c156449e1927}
\centering 
\begin{threeparttable}

\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.0704\linewidth-2\tabcolsep}p{\dimexpr.2719\linewidth-2\tabcolsep}p{\dimexpr.07559999999999999\linewidth-2\tabcolsep}p{\dimexpr.07340000000000003\linewidth-2\tabcolsep}p{\dimexpr.06589999999999998\linewidth-2\tabcolsep}p{\dimexpr.08319999999999999\linewidth-2\tabcolsep}p{\dimexpr.0832\linewidth-2\tabcolsep}p{\dimexpr.07640000000000001\linewidth-2\tabcolsep}p{\dimexpr.07109999999999999\linewidth-2\tabcolsep}p{\dimexpr.0598\linewidth-2\tabcolsep}p{\dimexpr.0691\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack S.No & \cAlignHack Formulation ratios in (mg) & \cAlignHack RS-SD 1 & \cAlignHack RS-SD 2 & \cAlignHack RS-SD 3 & \cAlignHack RS-SD 4 & \cAlignHack RS-SD 5 & \cAlignHack RS-SD 6 & \cAlignHack RS-SD 7 & \cAlignHack RS-SD 8 & \cAlignHack RS-SD 9\\
\tblmidrule 
\cAlignHack 1 &
  \cAlignHack Rosuvastatin SD &
  \cAlignHack 120 &
  \cAlignHack 200 &
  \cAlignHack 280 &
  \cAlignHack 120 &
  \cAlignHack 200 &
  \cAlignHack 280 &
  \cAlignHack 120 &
  \cAlignHack 200 &
  \cAlignHack 280\\
\cAlignHack 2 &
  \cAlignHack Lactose &
  \cAlignHack 175 &
  \cAlignHack 95 &
  \cAlignHack 15 &
  \cAlignHack 175 &
  \cAlignHack 95 &
  \cAlignHack 15 &
  \cAlignHack 175 &
  \cAlignHack 95 &
  \cAlignHack 15\\
\cAlignHack 3 &
  \cAlignHack HPMC E 15 &
  \cAlignHack 140 &
  \cAlignHack 140 &
  \cAlignHack 140 &
  \cAlignHack 140 &
  \cAlignHack 140 &
  \cAlignHack 140 &
  \cAlignHack 140 &
  \cAlignHack 140 &
  \cAlignHack 140\\
\cAlignHack 4 &
  \cAlignHack PVPK30 &
  \cAlignHack 30 &
  \cAlignHack 30 &
  \cAlignHack 30 &
  \cAlignHack 30 &
  \cAlignHack 30 &
  \cAlignHack 30 &
  \cAlignHack 30 &
  \cAlignHack 30 &
  \cAlignHack 30\\
\cAlignHack 5 &
  \cAlignHack Magnesium stearate &
  \cAlignHack 20 &
  \cAlignHack 20 &
  \cAlignHack 20 &
  \cAlignHack 20 &
  \cAlignHack 20 &
  \cAlignHack 20 &
  \cAlignHack 20 &
  \cAlignHack 20 &
  \cAlignHack 20\\
\cAlignHack 6 &
  \cAlignHack Talc &
  \cAlignHack 15 &
  \cAlignHack 15 &
  \cAlignHack 15 &
  \cAlignHack 15 &
  \cAlignHack 15 &
  \cAlignHack 15 &
  \cAlignHack 15 &
  \cAlignHack 15 &
  \cAlignHack 15\\
\cAlignHack 7 &
  \cAlignHack Total &
  \cAlignHack 500 &
  \cAlignHack 500 &
  \cAlignHack 500 &
  \cAlignHack 500 &
  \cAlignHack 500 &
  \cAlignHack 500 &
  \cAlignHack 500 &
  \cAlignHack 500 &
  \cAlignHack 500\\
\tblbottomrule 
\end{tabulary}\par 
\begin{tablenotes}\footnotesize 
    
\item{DRUG-Rosuvastatin (RS), HPMC-Hydroxy propyl methylcellulose (HPMC), Polyvinyl pyrrolidine K30 (PVP K30)}
\end{tablenotes}
\end{threeparttable}

\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Micromeritic Parameters of Rosuvastatin Prolonged-Release Tablets} }
\label{tw-110435b917a9}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1434\linewidth-2\tabcolsep}p{\dimexpr.1531\linewidth-2\tabcolsep}p{\dimexpr.1738\linewidth-2\tabcolsep}p{\dimexpr.20840000000000003\linewidth-2\tabcolsep}p{\dimexpr.15029999999999998\linewidth-2\tabcolsep}p{\dimexpr.171\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}{\multirow{2}{*}{\cAlignHack F. Code }} & \multicolumn{2}{p{\dimexpr(.3269\linewidth-2\tabcolsep)}}{\cAlignHack Derived Properties } & \multicolumn{3}{p{\dimexpr(.52970000000000006\linewidth-2\tabcolsep)}}{\cAlignHack Flow Properties }\\
\rowcolor{kwdboxcolor} & \cAlignHack Bulk density \mbox{}\protect\newline  (g/cm\ensuremath{^{3}})  & \cAlignHack Tapped density (g/cm\ensuremath{^{3}}) & \cAlignHack Angle of repose \mbox{}\protect\newline  (Degree) & \cAlignHack Carr's index \mbox{}\protect\newline  (\%)  & \cAlignHack Hausner's ratio (\%) \\
\tblmidrule 
\cAlignHack RS SD-1 &
  \cAlignHack 0.47 &
  \cAlignHack 0.59 &
  \cAlignHack 35.7 &
  \cAlignHack 20.3 &
  \cAlignHack 1.25\\
\cAlignHack RS SD-2 &
  \cAlignHack 0.53 &
  \cAlignHack 0.64 &
  \cAlignHack 38.6 &
  \cAlignHack 18.6 &
  \cAlignHack 1.20\\
\cAlignHack RS SD-3 &
  \cAlignHack 0.58 &
  \cAlignHack 0.61 &
  \cAlignHack 16.17 &
  \cAlignHack 4.91 &
  \cAlignHack 1.044\\
\cAlignHack RS SD-4 &
  \cAlignHack 0.52 &
  \cAlignHack 0.56 &
  \cAlignHack 14.5 &
  \cAlignHack 7.14 &
  \cAlignHack 1.096\\
\cAlignHack RS SD-5 &
  \cAlignHack 0.66 &
  \cAlignHack 0.70 &
  \cAlignHack 21.3 &
  \cAlignHack 5.71 &
  \cAlignHack 1.06\\
\cAlignHack RS SD-6 &
  \cAlignHack 0.78 &
  \cAlignHack 0.81 &
  \cAlignHack 19.2 &
  \cAlignHack 3.70 &
  \cAlignHack 1.038\\
\cAlignHack RS SD-7 &
  \cAlignHack 0.58 &
  \cAlignHack 0.61 &
  \cAlignHack 16.17 &
  \cAlignHack 4.91 &
  \cAlignHack 1.044\\
\cAlignHack RS SD-8 &
  \cAlignHack 0.57 &
  \cAlignHack 0.61 &
  \cAlignHack 9.92 &
  \cAlignHack 6.55 &
  \cAlignHack 1.062\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Evaluation parameters of Rosuvastatin calcium prolonged-release tablets} }
\label{tw-6bd2f42b92e8}
\centering 
\begin{threeparttable}

\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1448\linewidth-2\tabcolsep}p{\dimexpr.1863\linewidth-2\tabcolsep}p{\dimexpr.1489\linewidth-2\tabcolsep}p{\dimexpr.18490000000000002\linewidth-2\tabcolsep}p{\dimexpr.1711\linewidth-2\tabcolsep}p{\dimexpr.164\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack F. \mbox{}\protect\newline Code & \cAlignHack Thickness \mbox{}\protect\newline (mean \ensuremath{\pm} \mbox{}\protect\newline SD) (mm) & \cAlignHack Hardness \mbox{}\protect\newline (Kg/cm\ensuremath{^{2}}) & \cAlignHack Weight variation (mean\ensuremath{\pm} SD) (mg) & \cAlignHack Drug content \mbox{}\protect\newline (mean\ensuremath{\pm}SD) & \cAlignHack Friability  \mbox{}\protect\newline  (\%)\\
\tblmidrule 
\cAlignHack RS SD-1 &
  \cAlignHack 5.25\ensuremath{\pm}0.2 &
  \cAlignHack 6.2 &
  \cAlignHack 495\ensuremath{\pm}0.5 &
  \cAlignHack 97.34\ensuremath{\pm}0.6 &
  \cAlignHack 0.215\\
\cAlignHack RS SD-2 &
  \cAlignHack 5.29\ensuremath{\pm}0.5 &
  \cAlignHack 6.4 &
  \cAlignHack 498\ensuremath{\pm}0.8 &
  \cAlignHack 98.10\ensuremath{\pm}0.1 &
  \cAlignHack 0.321\\
\cAlignHack RS SD-3 &
  \cAlignHack 5.31\ensuremath{\pm}0.3 &
  \cAlignHack 5.9 &
  \cAlignHack 497\ensuremath{\pm}0.5 &
  \cAlignHack 97.87\ensuremath{\pm}0.1 &
  \cAlignHack 0.220\\
\cAlignHack RS SD-4 &
  \cAlignHack 5.28\ensuremath{\pm}0.2 &
  \cAlignHack 6.1 &
  \cAlignHack 502\ensuremath{\pm}0.2 &
  \cAlignHack 98.40\ensuremath{\pm}0.7 &
  \cAlignHack 0.183\\
\cAlignHack RS SD-5 &
  \cAlignHack 5.35\ensuremath{\pm}0.3 &
  \cAlignHack 5.9 &
  \cAlignHack 495\ensuremath{\pm}0.3 &
  \cAlignHack 98.50\ensuremath{\pm}0.2 &
  \cAlignHack 0.179\\
\cAlignHack RS SD-6 &
  \cAlignHack 5.30\ensuremath{\pm}0.5 &
  \cAlignHack 5.9 &
  \cAlignHack 501\ensuremath{\pm}0.6 &
  \cAlignHack 99.30\ensuremath{\pm}0.5 &
  \cAlignHack 0.112\\
\cAlignHack RS SD-7 &
  \cAlignHack 5.28\ensuremath{\pm}0.6 &
  \cAlignHack 6.4 &
  \cAlignHack 496\ensuremath{\pm}0.1 &
  \cAlignHack 98.43\ensuremath{\pm}0.5 &
  \cAlignHack 0.134\\
\cAlignHack RS SD-8 &
  \cAlignHack 5.30\ensuremath{\pm}0.7 &
  \cAlignHack 6.2 &
  \cAlignHack 498\ensuremath{\pm}0.4 &
  \cAlignHack 97.78\ensuremath{\pm}0.3 &
  \cAlignHack 0.131\\
\tblbottomrule 
\end{tabulary}\par 
\begin{tablenotes}\footnotesize 
    
\item{(*Data from each profile is presented in mean\ensuremath{\pm}SD (n=3))}
\end{tablenotes}
\end{threeparttable}

\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Cumulative drug release of Rosuvastatin prolonged-release tablets} }
\label{tw-19c01448f3b9}
\centering 
\begin{threeparttable}

\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.11\linewidth-2\tabcolsep}p{\dimexpr.11\linewidth-2\tabcolsep}p{\dimexpr.11\linewidth-2\tabcolsep}p{\dimexpr.1137\linewidth-2\tabcolsep}p{\dimexpr.1063\linewidth-2\tabcolsep}p{\dimexpr.11\linewidth-2\tabcolsep}p{\dimexpr.11\linewidth-2\tabcolsep}p{\dimexpr.11\linewidth-2\tabcolsep}p{\dimexpr.12\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}{\multirow{2}{*}{\cAlignHack Time \mbox{}\protect\newline (hrs)}} & \multicolumn{8}{p{\dimexpr(.89\linewidth-2\tabcolsep)}}{\cAlignHack \% Cumulative drug release}\\
\rowcolor{kwdboxcolor} & \cAlignHack RS SD-1 & \cAlignHack RS SD-2 & \cAlignHack RS SD-3 & \cAlignHack RS SD-4 & \cAlignHack RS SD-5 & \cAlignHack RS SD-6 & \cAlignHack RS SD-7 & \cAlignHack RS SD-8\\
\tblmidrule 
\cAlignHack 1 &
  \cAlignHack 18\ensuremath{\pm}1.32 &
  \cAlignHack 16.2\ensuremath{\pm}2.11 &
  \cAlignHack 10.8\ensuremath{\pm}2.01 &
  \cAlignHack 12.6\ensuremath{\pm}1.11 &
  \cAlignHack 16.2\ensuremath{\pm}1.32 &
  \cAlignHack 15.3\ensuremath{\pm}1.10 &
  \cAlignHack 10.2\ensuremath{\pm}1.23 &
  \cAlignHack 9.30\ensuremath{\pm}1.21\\
\cAlignHack 2 &
  \cAlignHack 30.6\ensuremath{\pm}2.34 &
  \cAlignHack 28.8\ensuremath{\pm}2.34 &
  \cAlignHack 18.0\ensuremath{\pm}1.34 &
  \cAlignHack 21.6\ensuremath{\pm}2.32 &
  \cAlignHack 36.0\ensuremath{\pm}3.21 &
  \cAlignHack 28.9\ensuremath{\pm}1.33 &
  \cAlignHack 16.1\ensuremath{\pm}2.12 &
  \cAlignHack 16.4\ensuremath{\pm}2.11\\
\cAlignHack 3 &
  \cAlignHack 46.8\ensuremath{\pm}3.23 &
  \cAlignHack 39.6\ensuremath{\pm}3.21 &
  \cAlignHack 28.8\ensuremath{\pm}2.34 &
  \cAlignHack 28.8\ensuremath{\pm}2.61 &
  \cAlignHack 41.4\ensuremath{\pm}2.45 &
  \cAlignHack 36.2\ensuremath{\pm}2.34 &
  \cAlignHack 23.2\ensuremath{\pm}1.32 &
  \cAlignHack 14.2\ensuremath{\pm}3.12\\
\cAlignHack 4 &
  \cAlignHack 55.8\ensuremath{\pm}3.12 &
  \cAlignHack 52.2\ensuremath{\pm}3.24 &
  \cAlignHack 37.8\ensuremath{\pm}3.21 &
  \cAlignHack 41.4\ensuremath{\pm}3.23 &
  \cAlignHack 54.0\ensuremath{\pm}3.21 &
  \cAlignHack 51.3\ensuremath{\pm}3.12 &
  \cAlignHack 31.4\ensuremath{\pm}3.24 &
  \cAlignHack 29.6\ensuremath{\pm}2.13\\
\cAlignHack 5 &
  \cAlignHack 76.0\ensuremath{\pm}4.21 &
  \cAlignHack 55.8\ensuremath{\pm}4.23 &
  \cAlignHack 48.6\ensuremath{\pm}3.33 &
  \cAlignHack 54.0\ensuremath{\pm}2.34 &
  \cAlignHack 63.0\ensuremath{\pm}2.12 &
  \cAlignHack 60.1\ensuremath{\pm}3.28 &
  \cAlignHack 39.6\ensuremath{\pm}2.33 &
  \cAlignHack 36.4\ensuremath{\pm}2.34\\
\cAlignHack 6 &
  \cAlignHack 92.5\ensuremath{\pm}4.81 &
  \cAlignHack 68.4\ensuremath{\pm}2.32 &
  \cAlignHack 57.6\ensuremath{\pm}3.18 &
  \cAlignHack 63.0\ensuremath{\pm}4.32 &
  \cAlignHack 70.2\ensuremath{\pm}3.56 &
  \cAlignHack 68.1\ensuremath{\pm}3.12 &
  \cAlignHack 48.4\ensuremath{\pm}2.11 &
  \cAlignHack 49.2\ensuremath{\pm}4.32\\
\cAlignHack 7 &
  \cAlignHack - &
  \cAlignHack 70.2\ensuremath{\pm}3.34 &
  \cAlignHack 64.8\ensuremath{\pm}2.19 &
  \cAlignHack 70.2\ensuremath{\pm}4.23 &
  \cAlignHack 81.0\ensuremath{\pm}5.21 &
  \cAlignHack 79.6\ensuremath{\pm}4.23 &
  \cAlignHack 58.8\ensuremath{\pm}3.45 &
  \cAlignHack 56.3\ensuremath{\pm}2.32\\
\cAlignHack 8 &
  \cAlignHack - &
  \cAlignHack 93.3\ensuremath{\pm}4.54 &
  \cAlignHack 76.7\ensuremath{\pm}4.32 &
  \cAlignHack 84.6\ensuremath{\pm}2.43 &
  \cAlignHack 86.0\ensuremath{\pm}2.35 &
  \cAlignHack 85.4\ensuremath{\pm}2.34 &
  \cAlignHack 66.4\ensuremath{\pm}4.12 &
  \cAlignHack 64.3\ensuremath{\pm}3.45\\
\cAlignHack 9 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack 89.2\ensuremath{\pm}4.15 &
  \cAlignHack 96.2\ensuremath{\pm}4.53 &
  \cAlignHack 94.6\ensuremath{\pm}5.62 &
  \cAlignHack 90.1\ensuremath{\pm}2.34 &
  \cAlignHack 78.2\ensuremath{\pm}4.87 &
  \cAlignHack 71.4\ensuremath{\pm}2.13\\
\cAlignHack 10 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack 97.5\ensuremath{\pm}3.89 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack 95.2\ensuremath{\pm}2.11 &
  \cAlignHack 85.3\ensuremath{\pm}4.32 &
  \cAlignHack 79.6\ensuremath{\pm}4.23\\
\tblbottomrule 
\end{tabulary}\par 
\begin{tablenotes}\footnotesize 
    
\item{(*Data from each profile is presented in mean\ensuremath{\pm}SD (n=3))}
\end{tablenotes}
\end{threeparttable}

\end{table*}
 drug release.
    
\section{RESULTS AND DISCUSSION}
Rosuvastatin is an HMG-COA reductase inhibitor that lowers the levels of lipids and lipoproteins in the blood. From the FT-IR results, it is evident that when Rosuvastatin calcium Figure~\ref{f-984c83db1aa2}  was compared with Eudragit, PEG 6000, and mixture Figure~\ref{f-3309e7f9f0aa}, Figure~\ref{f-d6840815d128}, and Figure~\ref{f-3bc8effcf248}  there is no characteristic change in the peaks. These results confirm that there is no chemical interaction between Rosuvastatin calcium and excipients. 


\bgroup
\fixFloatSize{images/3ab6bc74-c633-4a4a-bf36-c73f81fef171-upicture5.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/3ab6bc74-c633-4a4a-bf36-c73f81fef171-upicture5.png}{\includegraphics{images/3ab6bc74-c633-4a4a-bf36-c73f81fef171-upicture5.png}}{}
\makeatother 
\caption{\boldmath {Cumulative \% drug release of Rosuvastatin prolonged release tablets}}
\label{f-939e3faafba4}
\end{figure}
\egroup
Percentage Yield of Rosuvastatin calcium SD was found to be satisfactory for RS SD-1 to RS SD-8 which ranges from 40 to 90\%. The percentage yield of RS SD-9 was found to be very low i.e 15.8 \%. Hence RS SD-9 was not used for the formulation of prolonged-release tablets. Results were shown in Table~\ref{tw-c156449e1927}.

Micromeritic properties showed poor flow properties for Rosuvastatin API due to its amorphous nature when compared with the formulations RS SD-1 to RS SD-8 and the results are tabulated in Table~\ref{tw-110435b917a9}.

Post-formulation parameters concluded that there should be a certain amount of strength and resistance to friability for the tablet, so that tablet should not break during handling which also shows an effect on dissolution. The hardness of Rosuvastatin calcium prolonged-release tablets ranges from 5.9 to 6.4 kg/cm\ensuremath{^{2}}. Friability ranges from 0.11 \% to 0.32\%. This indicates that acceptable resistance is shown by Rosuvastatin calcium prolonged-release tablets to withstand handling and the results are given in Table~\ref{tw-6bd2f42b92e8}.

\textit{In-vitro} dissolution studies showed that the percent drug release has been retarded using Eudragit L-100 and the results are shown in Table~\ref{tw-19c01448f3b9}  and Figure~\ref{f-939e3faafba4}. For all the formulations the dissolution was conducted for twelve hours and among all the formulations, RS SD-3 showed optimum release profile indicating it to be the best formulation in the present research.
    
\section{CONCLUSION}
From the present research, it was concluded that the formulation RS SD-3 (Rosuvastatin: Eudragit L100 at 1:6) of Rosuvastatin calcium has achieved 97.5 \ensuremath{\pm} 3.89\% drug release for 10 Hrs. Results indicated that drug release has been retarded with an increase in the viscosity of Eudragit L100. The above formulation may also decrease gastric irritation and may improve patient compliance with the reduction in dosage frequency.
\section*{Acknowledgements}The authors are heartily thankful to Drugs India and Dr. M. Gobinath M.Pharm, Ph.D, Principal, Ratnam Institute of Pharmacy for permitting us to do the work and providing all the necessary facilities.

\textbf{Conflict of Interest}

The authors declare that no conflict of interest associated with this work.

\textbf{Contribution of Authors}

Authors declare that, the work done by the names mentioned in the article and all the liabilities and claims related to the content of the article will be borne by the authors.

\textbf{Funding Support}

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

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