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\title{Comparative Study of Different Brands of Alprazolam}
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             \author[1]{Dr. Safila  Naveed}

             \author[2]{Fatima  Qamar}

             \affil[1]{  Jinnah University for women Karachi}

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\date{\small \em Received: 11 December 2013 Accepted: 4 January 2014 Published: 15 January 2014}

\maketitle


\begin{abstract}
        


Benzodizapenes are the most widely used anxiolytic drug. They have largely replaced barbiturates and meprobamate in the treatment of Anxiety because they are safer and more effective. Alprazolam belongs to this class of drugs, it is used for the treatment of the anxiety symptoms of panic disorders.Present study deals with a brief overview of the comparative study of different brands of Alprazolam tablets according to Pharmacopeia (BP) & United States Pharmacopeia (USP) . for this reason.3 differen brands of Alprazolam 0.5 mg tablets have been evaluated using quality control test of thickness, hardness, weight variation and friability to assess that whether these 3 brands are pharmaceutically equivalent.

\end{abstract}


\keywords{thickness, hardness, weight variation and friability, alprazolam.}

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\let\tabcellsep& 	 	 		 
\section[{Introduction}]{Introduction}\par
lprazolam is a triazolobenzodiazepine. It is used in anxiety states and panic disorders \hyperref[b0]{[1,}\hyperref[b1]{2]}. Benzodiazepines are commonly used for deliberate self poisoning. It has been observed that in approximately one third of cases of deliberate self poisoning benzodizapenes are being used \hyperref[b2]{[3]}. Alprazolam is a newer benzodiazepine and is used more commonly in overdose and no previous series of alprazolam poisonings were found. 14 case reports have been published including 5 reported deaths,2 in which alprazolam was ingested alone \hyperref[b3]{[4]}. According to reports published by American Association of Poison Control Centers National Data Collection System indicated that alprazolam was involved in thirty four fatal deliberate self poisonings over ten years 1992-2001 compared with thirty fatal deliberate self poisonings involving diazepam \hyperref[b4]{[5]}. This reveals significant alprazolam toxicity if prescribing practices in the United States (US) mirror Australian trends where diazepam is prescribed at five to ten times the rate of alprazolam. A British study showed the fatal toxicity index (deaths per million prescriptions) for diazepam was 4.0 compared with 5.9 for alprazolam. \hyperref[b5]{[6]}. These data suggest that alprazolam is more toxic in overdose than other benzodiazepines.\par
In human liver this drug is metabolized by CYP3A enzymes to hydroxylated metabolites . 4-hydroxy alprazolam (4-OHALP) is the major and less active metabolite while ?-Hydroxy alprazolam (?-OHALP) is the Author ? ?: Faculty of Pharmacy Jinnah University for women Karachi. e-mails: safila117@yahoo.com, fatimamudassar2009@hotmail.com minor and active metabolite. There is an intrinsic difference in the biotransformation of alprazolam in liver and brain. As P450 enzymes present in brain is one-10th to one-15th of liver \hyperref[b6]{[7]} II.    The official range of hardness stated in BP/USP is not less than 4.00 Kg of pressure is required to break a tablet, so all of the samples were tested for hardness. 
\section[{d) Friability}]{d) Friability}\par
To evaluate how well the tablets stands up to coating, packing, shipping and other processing friability test were conducted. From each brand of legal and illegal products, 20 tablets were taken and de dusted before weighing, after weighing the tablet were placed in drum of friability tester of which each tablet rotated 100 times. Finally 20 tablets of each brand were de dusted and reweighed and their percentage losses of weight were calculated. According to BP \& USP the total weight loss should not be more than one percent and no tablet should show any type of break or crack.\par
Thickness Test: Thickness of above mentioned tablets including average , standard deviation, upper and lower limits are in accordance with BP/USP III. 
\section[{Results}]{Results}\par
Weight Variation Test: Wt. variation test of alprazolam tablets proved statistically that all the tablets were in accordance to the BP/USP requirements. (Table  {\ref -}  
\section[{Discusion}]{Discusion}\par
Uniformity of weight is compendia standard while hardness and friability are non compendia standards to assess the quality of the tablet. Friability is now included in USP. 
\section[{a) Weight Variation}]{a) Weight Variation}\par
The table 1-3 indicate that weight variation values of Neuxam , Alp , Nervin showed that among three brands Alp has the highest value of the mean as compared to other brands. The requirements are met with weight variation qaccording to USP that is ,weight of not more than two tablets out of all brands differs from the average weight by more than 7.5\% b) Friability\par
The table 3 and figure  {\ref 5}(\%weight loss for Nexaum , Alp , Nervin ) showed that the Nexaum has the highest \% weight lost and Alp has the lowest \% weight lost when compared to Nervan.\par
All the three brands have less than 1\% of weight lost which showed that these brands met the USP requirement. 
\section[{c) Hardness}]{c) Hardness}\par
The official range of hardness stated in BP/USP is not less than 4.00 Kg of pressure is required to break a tablet, so all of the samples were tested for hardness.\par
The table and figure showed that Nervin has the highest hardness value and Alp has showed lowest hardness value. It shows that Alp showed to meet the USP requirement while the other two brands are beyond the USP limit.     \begin{figure}[htbp]
\noindent\textbf{}\includegraphics[]{image-2.png}
\caption{\label{fig_0}}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{}\includegraphics[]{image-3.png}
\caption{\label{fig_1}A}\end{figure}
  \begin{figure}[htbp]
\noindent\textbf{A} \par 
\begin{longtable}{P{0.29078947368421054\textwidth}P{0.4194078947368421\textwidth}P{0.13980263157894737\textwidth}}
Dosage form\tabcellsep Average\tabcellsep Percentage\\
\tabcellsep weight\tabcellsep deviation\\
Uncoated\tabcellsep 80 mg or less\tabcellsep 10\\
and film coated\tabcellsep More than 80 mg but\tabcellsep \\
tablets\tabcellsep less than 250 mg\tabcellsep 7.5\\
\tabcellsep 250 mg or more\tabcellsep 5\\
c) Hardness\tabcellsep \tabcellsep \end{longtable} \par
 
\caption{\label{tab_0}Table A :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{1} \par 
\begin{longtable}{P{0.1691326530612245\textwidth}P{0.2645408163265306\textwidth}P{0.1951530612244898\textwidth}P{0.22117346938775512\textwidth}}
\tabcellsep \multicolumn{2}{l}{Different Brands}\tabcellsep \\
\multicolumn{3}{l}{Tablets Neuxam Alp}\tabcellsep Nervin\\
1\tabcellsep 179\tabcellsep 195\tabcellsep 165\\
2\tabcellsep 173\tabcellsep 199\tabcellsep 158\\
3\tabcellsep 180\tabcellsep 200\tabcellsep 150\\
4\tabcellsep 178\tabcellsep 200\tabcellsep 156\\
5\tabcellsep 180\tabcellsep 202\tabcellsep 159\\
6\tabcellsep 190\tabcellsep 200\tabcellsep 156\\
7\tabcellsep 190\tabcellsep 203\tabcellsep 151\\
8\tabcellsep 178\tabcellsep 205\tabcellsep 156\\
9\tabcellsep 179\tabcellsep 198\tabcellsep 160\\
10\tabcellsep 176\tabcellsep 205\tabcellsep 154\\
11\tabcellsep 173\tabcellsep 200\tabcellsep 160\\
12\tabcellsep 176\tabcellsep 195\tabcellsep 158\\
13\tabcellsep 180\tabcellsep 199\tabcellsep 151\\
14\tabcellsep 177\tabcellsep 203\tabcellsep 156\\
15\tabcellsep 173\tabcellsep 198\tabcellsep 150\end{longtable} \par
 
\caption{\label{tab_2}Table 1 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{2} \par 
\begin{longtable}{P{0.12444751381215469\textwidth}P{0.07748618784530387\textwidth}P{0.05870165745856354\textwidth}P{0.1808011049723757\textwidth}P{0.0962707182320442\textwidth}P{0.08922651933701657\textwidth}P{0.22306629834254144\textwidth}}
\multicolumn{4}{l}{Tablets Average}\tabcellsep Standard\tabcellsep Upper limit\tabcellsep Lower limit\\
\tabcellsep \tabcellsep \multicolumn{2}{l}{(Gm)}\tabcellsep deviation\tabcellsep (X+3S)\tabcellsep (X-3S)\\
\multicolumn{2}{l}{Neuxam}\tabcellsep \multicolumn{2}{l}{0.17985}\tabcellsep 0.005687\tabcellsep 0.196911\tabcellsep 0.162789\\
Alp\tabcellsep \tabcellsep \multicolumn{2}{l}{0.20025}\tabcellsep 0.002712\tabcellsep 0.2083\tabcellsep 0.19211\\
\multicolumn{2}{l}{Nervin}\tabcellsep \multicolumn{2}{l}{0.15665}\tabcellsep 0.004308\tabcellsep 0.16957\tabcellsep 0.1437\\
\tabcellsep \tabcellsep \tabcellsep \multicolumn{3}{l}{Table 3 : Weight Variation Test}\\
Tablets\tabcellsep \multicolumn{2}{l}{Result (Gm)}\tabcellsep \multicolumn{3}{l}{BP/USP Specification}\tabcellsep Deviation from BP/USP Specification\\
Neuxam\tabcellsep \multicolumn{2}{l}{0.17985}\tabcellsep \tabcellsep \\
Alp Nervin\tabcellsep \multicolumn{2}{l}{0.20025 0.15665}\tabcellsep \multicolumn{3}{l}{Deviation should be ±7.5\%}\tabcellsep Within specified limit\end{longtable} \par
 
\caption{\label{tab_3}Table 2 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{4} \par 
\begin{longtable}{P{0.19720000000000001\textwidth}P{0.204\textwidth}P{0.204\textwidth}P{0.24479999999999996\textwidth}}
\multicolumn{3}{l}{Tablets Neuxam Alp}\tabcellsep Nervin\\
1\tabcellsep 3.3\tabcellsep 3.2\tabcellsep 3.2\\
2\tabcellsep 3.4\tabcellsep 3.1\tabcellsep 3.2\\
3\tabcellsep 3.3\tabcellsep 3.2\tabcellsep 3.2\\
4\tabcellsep 3.2\tabcellsep 3.1\tabcellsep 3.2\\
5\tabcellsep 3.5\tabcellsep 3.1\tabcellsep 3.1\\
6\tabcellsep 3.3\tabcellsep 3.1\tabcellsep 3.1\\
7\tabcellsep 3.3\tabcellsep 3.1\tabcellsep 3.1\\
8\tabcellsep 3.5\tabcellsep 3.1\tabcellsep 3.1\\
9\tabcellsep 3.4\tabcellsep 3.1\tabcellsep 3.1\\
10\tabcellsep 3.3\tabcellsep 3.1\tabcellsep 3.1\end{longtable} \par
 
\caption{\label{tab_4}Table 4 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{5} \par 
\begin{longtable}{P{0.1316901408450704\textwidth}P{0.18556338028169012\textwidth}P{0.17359154929577464\textwidth}P{0.17957746478873238\textwidth}P{0.17957746478873238\textwidth}}
\tabcellsep Average\tabcellsep Standard\tabcellsep Upper limit\tabcellsep Lower limit (X-\\
Tablets\tabcellsep Thickness mm\tabcellsep deviation\tabcellsep (X+3S)\tabcellsep 3S)\\
Neuxam\tabcellsep 3.35\tabcellsep 0.09\tabcellsep 3.64\tabcellsep 3.05\\
Alp\tabcellsep 3.12\tabcellsep 0.04\tabcellsep 3.246\tabcellsep 2.99\\
Nervin\tabcellsep 3.14\tabcellsep 0.05\tabcellsep 3.29\tabcellsep 2.98\end{longtable} \par
 
\caption{\label{tab_5}Table 5 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{6} \par 
\begin{longtable}{P{0.10252918287937743\textwidth}P{0.1554474708171206\textwidth}P{0.15875486381322956\textwidth}P{0.17198443579766537\textwidth}P{0.261284046692607\textwidth}}
\tabcellsep \tabcellsep \tabcellsep \tabcellsep Year 2014\\
\tabcellsep \tabcellsep \tabcellsep \tabcellsep 27\\
\tabcellsep \tabcellsep \tabcellsep \tabcellsep Volume XIV Issue III Version I\\
\tabcellsep \tabcellsep \tabcellsep \tabcellsep ( B )\\
\multicolumn{2}{l}{Tablets Neuxam}\tabcellsep Alp\tabcellsep Nervin\tabcellsep Medical Research\\
1 2 3 4 5 6 7\tabcellsep 7.69 5.05 6.14 7.40 7.88 7.306 7.16\tabcellsep 2.19 2.5 2.47 2.41 2.21 2.05 1.92\tabcellsep 12.2 12.0 11.7 15.2 12.1 10.2 13.2\tabcellsep Global Journal of\\
8\tabcellsep 7.73\tabcellsep 2.73\tabcellsep 14.9\tabcellsep \\
9\tabcellsep 7.60\tabcellsep 2.45\tabcellsep 13.2\tabcellsep \\
10\tabcellsep 3.91\tabcellsep 1.95\tabcellsep 13.8\tabcellsep \end{longtable} \par
  {\small\itshape [Note: © 2014 Global Journals Inc. (US)]} 
\caption{\label{tab_6}Table 6 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{7} \par 
\begin{longtable}{P{0.10625\textwidth}P{0.13522727272727272\textwidth}P{0.2028409090909091\textwidth}P{0.2028409090909091\textwidth}P{0.2028409090909091\textwidth}}
Tablets\tabcellsep Average (Kg)\tabcellsep Standard deviation\tabcellsep Upper limit (X+3S)\tabcellsep Lower limit (X-3S)\\
Neuxam\tabcellsep 6.7866\tabcellsep 1.335725\tabcellsep 10.79377\tabcellsep 2.779426\\
Alp\tabcellsep 2.288\tabcellsep 0.265949\tabcellsep 3.085847\tabcellsep 1.490153\\
Nervin\tabcellsep 12.85\tabcellsep 1.524795\tabcellsep 17.42439\tabcellsep 8.275615\end{longtable} \par
 
\caption{\label{tab_7}Table 7 :}\end{figure}
 		 		\backmatter  			  				\begin{bibitemlist}{1}
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\bibitem[Henderson et al. ()]{b2}\label{b2} 	 		‘Experience with 732 acute overdose patients admitted to an intensive care unit over six years’.  		 			A Henderson 		,  		 			M Wright 		,  		 			S M Pond 		.  	 	 		\textit{Med J Aust}  		1993. 158 p. .  	 
\bibitem[Serfaty and Masterton ()]{b5}\label{b5} 	 		‘Fatal poisonings attributed to benzodiazepines in Britain during the 1980s’.  		 			M Serfaty 		,  		 			G Masterton 		.  	 	 		\textit{Br J Psychiatry}  		1993. 163 p. .  	 
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\end{document}
