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\def\citeauthor{~Ajith~Reddy~C,
              ~Uma~Sankar~K,
              ~Kishore~Babu~M}
\def\citetitle{Formulation and Evaluation of Fast Dissolving Oral Films of Risperidone}
\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{Ajith Reddy C et al.}
\firstPage{35}
\articleType{Original Article}
\receivedDate{10 Dec 2021}
\acceptedDate{30 Dec 2021}
\revisedDate{28 Dec 2021}
\journalVolume{2}
\journalIssue{1}
\journalDoi{fjphs.v2i1.168}
\copyrightYear{2022}
\eISSN{2583-116X}
\journalDoi{fjphs.v2i1.168}
\def\authorCount{3}
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\def\journalTitle{Future Journal of Pharmaceuticals and Health Sciences}

\title{Formulation and Evaluation of Fast Dissolving Oral Films of Risperidone}
\author{Ajith~Reddy~C\textsuperscript{*},  
            Uma~Sankar~K\textsuperscript{\href{https://orcid.org/0000-0001-5349-7485}{\XeTeXLinkBox{\includegraphics[height=7pt]{orcid-logo-pharmascope.pdf}}}}, 
            Kishore~Babu~M~\\[5pt]{Department of Pharmaceutics, Krishna Teja Pharmacy College, Chadalawada Nagar, Renigunta Road, Tirupathi-517506, Andhra Pradesh, India}}

\begin{abstract}
The current research was primarily directed to develop and implement and evaluate rapidly disintegrating Risperidone using HPMC E15 and HPMC E5. The acceptable plasticizer but also its concentration were based on the basis of flexibility, tensile strength and stickiness of a film. The films are solvent casting process. The thicknesses of the films were in the range of 0.234 mm to 0.271 mm. The weights of films have been noticed being in the range of 83 to 91. Folding endurance of films had been noticed being in the scope of 38 \ensuremath{\pm} 1 to 57 \ensuremath{\pm} 2. The surface PH of all films have been encountered to really be neutral since there was no change in color inside the litmus paper.  The disintegration time of such ready films were all in the scope of 19 sec to 32 sec. 
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Fast Dissolving,\newline Oral Films,\newline Risperidone,\newline In-vitro Dissolution,\newline Disintegration
\end{keywords}
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\makeatletter{\raggedright{\Large$^\ast$}Corresponding Author\par Name:\ Ajith~Reddy~C~\\ Phone:\ +91 8500170013~\\  Email:\ ajithreddy861998@gmail.com
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\section{Introduction}
Even after of many of advance that have been made in variety delivery mechanism established for administering of varied drugs and via alternate paths such as oral, parenteral, transdermal, nasal, etc., the oral drug delivery is taken into account as one of the most efficient and also the preferred approach of administration \unskip~\cite{1302410:23945019}. More so than 70\% of medicine can be found available in the market within form of oral drug delivery. Because of this problem roughly 50\% of population mainly paediatric population and elderly individuals generally avoid orally ingested solid oral dosage. Keeping the convenience of administration but also trying to swallow in mind, drug research has resulted in the development of fast dissolving drug delivery \unskip~\cite{1302410:23945021}. Risperidone is effective for going to treat the positively and negatively symptoms of schizophrenia compared to first generation antipsychotics \unskip~\cite{1302410:23945060}.
    
\section{MATERIALS }
Risperidone was a gift sample from Pharma train Hyderabad. HPMC E15, HPMC E5, Propylene glycol, Sorbitol, Aspartame, Tween 80, Citric acid and flavouring agent seemed to be actually bought from S.D. Fine chemicals, Mumbai.
    
\section{METHODOLOGY}
\textbf{Compatibility Studies}

Sample concentration in KBr must be within the limits of 0.2\% to 1\%. The thickness of the pellet is much greater than a liquid film, so sample with low concentration is required. Too high concentration generally leads to difficulties in obtaining clear pellets \unskip~\cite{1302410:23945061}.

\textbf{Formulation of Risperidone Fast Dissolving Films}

Mouth dissolving film of Risperidone was prepared by solvent casting technique. Solution A was decided to make by solubilising HPMC-E15 polymer in five ml of liquid. Solution B was already decided to make by dissolving Risperidone, Aspartam, Sorbitol \& citric acid in 5 ml of ethanol. The source of ideas `A' and `B' have been combined and incensed for 30min and add Propylene glycol and tween 80 and flavouring agent and continue stirring for 10mins [Table~\ref{tw-2db29de9fc6b}]. The solutions company were poured it onto glass petri plate of 9 cm diameter but were located in the oven at 70\ensuremath{^\circ}C until a wax coated film was created and after that solidified films have been cut into rectangular or circular pieces with 4.0 cm\ensuremath{^{2}} (2.0 cm \ensuremath{\times} 2.0 cm) large surface area. Desired quantity of Risperidone had been 10 mg (dose of drug) per 4.0 cm\ensuremath{^{2}} feature films \unskip~\cite{1302410:23945095}.


\begin{table*}[!htbp]
\caption{\boldmath {Formulation of Risperidone Fast Dissolving Films} }
\label{tw-2db29de9fc6b}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2437\linewidth-2\tabcolsep}p{\dimexpr.0982\linewidth-2\tabcolsep}p{\dimexpr.0506\linewidth-2\tabcolsep}p{\dimexpr.1045\linewidth-2\tabcolsep}p{\dimexpr.09110000000000003\linewidth-2\tabcolsep}p{\dimexpr.1044\linewidth-2\tabcolsep}p{\dimexpr.0839\linewidth-2\tabcolsep}p{\dimexpr.07839999999999998\linewidth-2\tabcolsep}p{\dimexpr.0713\linewidth-2\tabcolsep}p{\dimexpr.07390000000000001\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Ingredients & F1 & F2 & F3 & F4 & F5 & F6 & F7 & F8 & F9\\
\tblmidrule 
Risperidone &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5\\
HPMC E15 &
  25 &
  30 &
  35 &
  40 &
  45 &
  50 &
  10 &
  20 &
  30\\
HPMC E5 &
  - &
  - &
  - &
  - &
  - &
  - &
  30 &
  20 &
  10\\
Propylene glycol &
  10 &
  10 &
  10 &
  10 &
  10 &
  10 &
  10 &
  10 &
  10\\
Sorbitol &
  34 &
  29 &
  24 &
  19 &
  14 &
  9 &
  19 &
  19 &
  19\\
Aspartame &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5\\
Tween 80 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5\\
Saliva stimulating agent (citric acid) &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5 &
  5\\
Flavouring agent &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5 &
  0.5\\
Total wt. (mg) &
  85 &
  85 &
  85 &
  85 &
  85 &
  85 &
  85 &
  85 &
  85\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
\textbf{Morphological Properties} \textbf{\space }

This measurement device has been quickly checked simply with testing process for physical features of films and assessment of surface by touch or consult \unskip~\cite{1302410:23945133}.

\textbf{Thickness Uniformity}

All the portions were evaluated for thickness through using calibrated Vernier caliper \unskip~\cite{1302410:23945134}.

\textbf{Weight Uniformity of Films}

Three films of each formulation trial of 2cm size have been taken and decided to weigh independently electronic balance and the average weights were determined by calculating \unskip~\cite{1302410:23945135}.

\textbf{Folding Endurance}

The Multiple films of each composition trial of 2cm length have been captured and concluded to weigh independently electronic weighing balance and the estimate weights were the flexibility of films can also be measured quantitative and qualitative in terms of folding endurance. The one strip of film was cut (approximately 2*2cm) and again and again folded at the same position until burst. The number of times the film may be folded at the same position without bursting gave the value of folding endurance \unskip~\cite{1302410:23945136}.

\textbf{Surface pH}

The surface pH was noted by trying to bring pH paper closer to the surface of the films and permitting it to equilibrium for 1min \unskip~\cite{1302410:23945095}.

\textit{\textbf{In vitro}} \textbf{ Disintegration Test}

In vitro disintegration rate is decided visibly in a glass baking dish 25ml water to roiling each 10 sec. The disintegration time is indeed the time whenever the film begins to break or disintegrates \unskip~\cite{1302410:23945881}.

\textit{\textbf{In vitro}} \textbf{ Dissolution Studies}

The dissolution medium consists entirely of 900 mL 6.8pH phosphate-buffer solution, retained at 37\ensuremath{\pm}0.5\ensuremath{^\circ}C and agitated at 50 rpm. One film has been used in each test. Samples of dissolution medium (5ml) have been withdrawn with syringe equipped with pre-filter at known intervals and release of drug was evaluated UV-spectrophotometer at 280nm. The quantity forced to withdrawn at every intervals was supplemented with newly quantity of dissolution medium. Cumulative percentage drug discharge of Risperidone was calculated and obtained by plotting on that time \unskip~\cite{1302410:23945976}.

\textbf{Mathematical Modeling for Drug Release Profile}

The data acquired from the \textit{in vitro }dissolution tests obtain the kinetic track record analysis \unskip~\cite{1302410:23945061}. 

Zero-order kinetics: \textit{Q \ensuremath{_{t}} = Q \ensuremath{_{o}} + K\ensuremath{_{o}} t}

First-order kinetics:\textit{Q\ensuremath{_{t}} = log Q\ensuremath{_{o}}+ K\ensuremath{_{1}}t}/2.303

\textbf{Stability Studies}

The stability study had been performed as per ICH guidelines for such period with one month at various accelerated temperature \unskip~\cite{1302410:23946056} and humidity conditions of 40\ensuremath{^\circ}C \ensuremath{\pm} 2\ensuremath{^\circ}C / 75\% \ensuremath{\pm} 5\% RH.
    
\section{RESULTS AND DISCUSSION}
\textbf{FT-IR Studies}

From drug excipient compatibility trend analysis, we referred to the omission of conversations among both pure drug and excipients [Figure~\ref{f-e4b16fc8a2ca}].


\bgroup
\fixFloatSize{images/23529e84-9c91-4fcf-a9d4-4f07c069ff31-upicture1.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/23529e84-9c91-4fcf-a9d4-4f07c069ff31-upicture1.png}{\includegraphics{images/23529e84-9c91-4fcf-a9d4-4f07c069ff31-upicture1.png}}{}
\makeatother 
\caption{\boldmath {FTIR Spectrum of Drug and Mixture of Compounds}}
\label{f-e4b16fc8a2ca}
\end{figure}
\egroup

\begin{table*}[!htbp]
\caption{\boldmath {Evaluation Parameters of Risperidone FDF} }
\label{tw-3457fe5ca677}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1555\linewidth-2\tabcolsep}p{\dimexpr.15850000000000003\linewidth-2\tabcolsep}p{\dimexpr.166\linewidth-2\tabcolsep}p{\dimexpr.16\linewidth-2\tabcolsep}p{\dimexpr.16\linewidth-2\tabcolsep}p{\dimexpr.20\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Formulation code & \cAlignHack Thickness (mm) & \cAlignHack Weight variation & \cAlignHack Folding endurance & \cAlignHack \% Assay & \cAlignHack Disintegration time (sec)\\
\tblmidrule 
\cAlignHack F1 &
  \cAlignHack 0.234 &
  \cAlignHack 87 &
  \cAlignHack 42 &
  \cAlignHack 99.13 &
  \cAlignHack 19\\
\cAlignHack F2 &
  \cAlignHack 0.271 &
  \cAlignHack 91 &
  \cAlignHack 51 &
  \cAlignHack 98.79 &
  \cAlignHack 24\\
\cAlignHack F3 &
  \cAlignHack 0.263 &
  \cAlignHack 83 &
  \cAlignHack 38 &
  \cAlignHack 99.82 &
  \cAlignHack 21\\
\cAlignHack F4 &
  \cAlignHack 0.247 &
  \cAlignHack 85 &
  \cAlignHack 57 &
  \cAlignHack 100.17 &
  \cAlignHack 27\\
\cAlignHack F5 &
  \cAlignHack 0.257 &
  \cAlignHack 87 &
  \cAlignHack 54 &
  \cAlignHack 99.48 &
  \cAlignHack 32\\
\cAlignHack F6 &
  \cAlignHack 0.234 &
  \cAlignHack 90 &
  \cAlignHack 49 &
  \cAlignHack 101.07 &
  \cAlignHack 28\\
\cAlignHack F7 &
  \cAlignHack 0.238 &
  \cAlignHack 86 &
  \cAlignHack 45 &
  \cAlignHack 100.29 &
  \cAlignHack 26\\
\cAlignHack F8 &
  \cAlignHack 0.265 &
  \cAlignHack 91 &
  \cAlignHack 39 &
  \cAlignHack 99.37 &
  \cAlignHack 23\\
\cAlignHack F9 &
  \cAlignHack 0.268 &
  \cAlignHack 87 &
  \cAlignHack 48 &
  \cAlignHack 100.53 &
  \cAlignHack 27\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {\textit{In-vitro} drug release data of formulation F1 to F9} }
\label{tw-fe6ccd178fcb}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.1432\linewidth-2\tabcolsep}p{\dimexpr.08470000000000002\linewidth-2\tabcolsep}p{\dimexpr.07840000000000001\linewidth-2\tabcolsep}p{\dimexpr.0937\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}p{\dimexpr.10\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}{\multirow{2}{*}{\cAlignHack Time  \mbox{}\protect\newline (min)}} & \multicolumn{9}{p{\dimexpr(.8568\linewidth-2\tabcolsep)}}{\cAlignHack \% Drug Release}\\
\rowcolor{kwdboxcolor} & \cAlignHack F1 & \cAlignHack F2 & \cAlignHack F3 & \cAlignHack F4 & \cAlignHack F5 & \cAlignHack F6 & \cAlignHack F7 & \cAlignHack F8 & \cAlignHack F9\\
\tblmidrule 
\cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0\\
\cAlignHack 3 &
  \cAlignHack 24 &
  \cAlignHack 23 &
  \cAlignHack 35 &
  \cAlignHack 27 &
  \cAlignHack 26 &
  \cAlignHack 24 &
  \cAlignHack 39 &
  \cAlignHack 63 &
  \cAlignHack 65\\
\cAlignHack 6 &
  \cAlignHack 31 &
  \cAlignHack 35 &
  \cAlignHack 46 &
  \cAlignHack 35 &
  \cAlignHack 39 &
  \cAlignHack 31 &
  \cAlignHack 61 &
  \cAlignHack 76 &
  \cAlignHack 86\\
\cAlignHack 9 &
  \cAlignHack 38 &
  \cAlignHack 41 &
  \cAlignHack 58 &
  \cAlignHack 49 &
  \cAlignHack 51 &
  \cAlignHack 53 &
  \cAlignHack 83 &
  \cAlignHack 83 &
  \cAlignHack 95\\
\cAlignHack 12 &
  \cAlignHack 53 &
  \cAlignHack 50 &
  \cAlignHack 72 &
  \cAlignHack 63 &
  \cAlignHack 68 &
  \cAlignHack 68 &
  \cAlignHack 97 &
  \cAlignHack 95 &
  \cAlignHack 100\\
\cAlignHack 15 &
  \cAlignHack 64 &
  \cAlignHack 59 &
  \cAlignHack 79 &
  \cAlignHack 75 &
  \cAlignHack 80 &
  \cAlignHack 81 &
  \cAlignHack 98 &
  \cAlignHack 99 &
  \cAlignHack -\\
\cAlignHack 18 &
  \cAlignHack 71 &
  \cAlignHack 70 &
  \cAlignHack 85 &
  \cAlignHack 86 &
  \cAlignHack 89 &
  \cAlignHack 95 &
  \cAlignHack 98 &
  \cAlignHack - &
  \cAlignHack -\\
\cAlignHack 21 &
  \cAlignHack 78 &
  \cAlignHack 82 &
  \cAlignHack 92 &
  \cAlignHack 97 &
  \cAlignHack 97 &
  \cAlignHack 99 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
\cAlignHack 24 &
  \cAlignHack 82 &
  \cAlignHack 89 &
  \cAlignHack 99 &
  \cAlignHack 99 &
  \cAlignHack 100 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
\cAlignHack 27 &
  \cAlignHack 85 &
  \cAlignHack 94 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
\cAlignHack 30 &
  \cAlignHack 91 &
  \cAlignHack 97 &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack - &
  \cAlignHack -\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {r\ensuremath{^{2 }}Values for Best Formulation F9} }
\label{tw-60d40d29c6c6}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.33\linewidth-2\tabcolsep}p{\dimexpr.33\linewidth-2\tabcolsep}p{\dimexpr.34\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Formulation code & \cAlignHack Zero order & \cAlignHack First order\\
\tblmidrule 
\cAlignHack F9 &
  \cAlignHack 0.789 &
  \cAlignHack 0.999\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {\textit{In-vitro} Release Profile of F9 Formulation Stability Studies} }
\label{tw-fe19f0a80b6b}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2941\linewidth-2\tabcolsep}p{\dimexpr.3816\linewidth-2\tabcolsep}p{\dimexpr.3243\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}\cAlignHack Time & \cAlignHack Initial & \cAlignHack 1 Month\\
\tblmidrule 
\cAlignHack 0 &
  \cAlignHack 0 &
  \cAlignHack 0\\
\cAlignHack 3 &
  \cAlignHack 65 &
  \cAlignHack 64\\
\cAlignHack 6 &
  \cAlignHack 86 &
  \cAlignHack 87\\
\cAlignHack 9 &
  \cAlignHack 95 &
  \cAlignHack 95\\
\cAlignHack 12 &
  \cAlignHack 100 &
  \cAlignHack 100\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
The inspection by condition monitoring of films and so by feel or touch, it explains that films are having surface texture and they are elegant. The thicknesses of the films were in the range of 0.234 mm to 0.271 mm. The weights of films have been noticed being in the range of 83 to 91. Folding endurance of films had been noticed being in the scope of 38\ensuremath{\pm} 1 to 57 \ensuremath{\pm} 2. The surface PH of all films has been encountered got really be neutral since there was no change in colour inside the litmus paper [Table~\ref{tw-3457fe5ca677}].  The disintegration time of such ready films were all in the scope of 19 sec to 32 sec.


\bgroup
\fixFloatSize{images/e8eeb3ef-94d3-4ed6-8594-36990335d343-upicture2.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/e8eeb3ef-94d3-4ed6-8594-36990335d343-upicture2.png}{\includegraphics{images/e8eeb3ef-94d3-4ed6-8594-36990335d343-upicture2.png}}{}
\makeatother 
\caption{\boldmath {Dissolution Profile for F1 to F9 Formulations}}
\label{f-9908240acefc}
\end{figure}
\egroup
\textbf{Stability Studies }

Selected formulation F9 was strip packed and stored at 40\ensuremath{^\circ}C \ensuremath{\pm} 2\ensuremath{^\circ}C / 75\% \ensuremath{\pm} 5\% RH [Table~\ref{tw-fe6ccd178fcb}, Table~\ref{tw-60d40d29c6c6}] or indeed a duration of 1 month [Table~\ref{tw-fe19f0a80b6b}]. Samples were evaluated now since storage for 1 month as well as assessed [Figure~\ref{f-9908240acefc}, Figure~\ref{f-0c34d11779bd}].


\bgroup
\fixFloatSize{images/6a8edc96-4118-47d8-9d32-27a7a7aa3686-upicture3.png}
\begin{figure}[!htbp]
\centering \makeatletter\IfFileExists{images/6a8edc96-4118-47d8-9d32-27a7a7aa3686-upicture3.png}{\includegraphics{images/6a8edc96-4118-47d8-9d32-27a7a7aa3686-upicture3.png}}{}
\makeatother 
\caption{\boldmath {\textit{In-vitro} Release Profile of F9 During Stability Studies}}
\label{f-0c34d11779bd}
\end{figure}
\egroup

    
\section{CONCLUSION}
Risperidone orally disintegrating films were successfully prepared with HPMC E15CPS and HPMC E15 \& HPMC E5 combination.  The disintegration time of the prepared films were in the range of 21sec to 32sec. The F9 formulation \textit{in vitro} disintegration time was below of 27 sec. It was concluded that formulations F9 were found to be satisfactory batch and were optimized for the desirable properties.
\section*{Acknowledgement}I would like to thanks to Dr. M. Kishore Babu Garu, Principal of Krishna Teja Pharmacy College, Chadalawada Nagar, Renigunta Road, Tirupathi-517506, Andhra Pradesh, India.

\textbf{Funding Support} \textbf{\space }

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

\textbf{Conflict of Interest}

The authors declare that there is no conflict of interest.
    

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