APPLICATION OF ANOVA STATISTICS AND DISSOLUTION DATA MODELING OF OPTIMIZED NIMODIPINE DISPERSIBLE TABLET AT VARIOUS CONCENTRATIONS OF CO-PROCESSED POLYMER (LUDIPRESS®) AND SUPER DISINTEGRANT BY DIRECT COMPRESSION METHOD.
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Keywords
dissolution, ANOVA, Superdisintegrant;, ludipress
Abstract
Objective: The study aims to formulate a fast dispersible tablet of Nimodipine using central composite rotatable Design technology using two independent variables such as ludipress (20-55%) and crospovidone (3-5%) hardness, disintegration and friability were dependent variables.
Method: Nine different formulations were designed each formulation of each powder blend was subjected to precompression testing such as tapped density, bulk density, angle of repose, Hausner's ratio, and cars index, and tablets were compressed by Direct compression method. Tablets were subjected to several compendial and non-compendial test
Results All nine formulations F1-F9 average weight was found to be 203.4±0.47-212.5±0.34 mg, Hardness was found to be within the limit 3.89±0.24-5.07±0.05kg. Tablet thickness and diameter were found to be in the range of 3.005±0.045 and 10.9±0.023. All test formulations F1-F9 disintegration was found to be within less than 3 minutes (8-20 seconds)
friability of all test formulation tablets was found to be within the limit of less than 1% (0.3-0.8% ). Percentage Assay of all formulations was found to be in the range of 97.86±0.04-101.3±0.07. ANOVA statistics and p-value were determined for all three responses of the optimized formulations model F value for all dependent responses hardness, friability, and disintegration was found to be 9.16, 5.34, and 6.07. The p-values for all dependent responses were found to be 0.004, 0.004, and 0.005. Fit statistics adequate precision showed signal-to-noise ratio which was found to be 8.136, 5.651, and 6.027 value which indicated the navigation of the design space. r2 value of all the responses was found to be 0.9 for hardness, 0.64 for friability, and 0.66 for disintegration which shows a significant correlation between dependent and independent variables. multiple point dissolution studies of all formulations F1-F9 were conducted at acetate buffer pH 4.5 and 0.3% sodium dodecyl sulfate (SDS). Samples were drawn at 5, 10, 15, 20, 30 and 45 minutes. Several kinetic models were applied to the dissolution data such as the First Order, Hixson Crowell, Higuchi, and Weibull models based on an r2 value close to 0.9 all the tested formulations F1-F9 followed the First Order and Weibull model. Similarity (f2) and dissimilarity factors (f1) were also calculated by choosing F3 formulations as standard based on a high drug release of 97.89% at 45 minutes. All test formulations were found to be in the limit Similarity (f2) (3-4) and dissimilarity factors (f1) (69-79). Conclusion: Nine different Nimodipine dispersible tablets were easily formulated by direct compression method and all tested compressed tablets passed pharmacopeial and non-pharmacopeial tests. All test formulations disintegrated within the specified limit hence a combination of ludipress and crospovidone was found to be an effective excipient in the field of formulation and development.
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Hira Akhtar
Department of Pharmaceutics, Nazeer Hussain University, Karachi Pakistan
Muhammad Ali
Faculty of Pharmacy and Pharmaceutical Sciences, Department of Pharmaceutics, University of Karachi
Syed Zohaib Hussain
Department of Pharmaceutics, Nazeer Hussain University, Karachi Pakistan
Rabia Humayoon
Jinnah college of Pharmacy, Sohail University
Saira Shahnaz
Department of Pharmacy Practice, Nazeer Hussain University, Karachi Pakistan
Hidayat ullah
Student of Department of Pharmacy, Nazeer Hussain University, Karachi, Pakistan
Amna Shaikh
Department of Pharmacology, Nazeer Hussain University, Karachi Pakistan
khawaja Zafar Ahmed
Department of Pharmacology, SBB Deewan University, Karachi, Pakistan
Shoaib Nawaz
Department of Pharmacy, University of Lahore, Sargodha Campus, Pakistan
Imran Ahmed
Department of Pharmacy Practice, Nazeer Hussain University, Karachi Pakistan
Syed Muhammad Yaseen
Student of MBBS, Jinnah Medical and Dental College, Karachi, Pakistan
Rukhsar Islam
Student of Department of Pharmacy, Nazeer Hussain University, Karachi, Pakistan
Muhammad Faizan Raza Alwani
Student of Department of Pharmacy, Nazeer Hussain University, Karachi, Pakistan
Hina Furqan
Faculty of Pharmacy, Department of Pharmaceutical Chemistry, Salim Habib University, Karachi
Raahim Ali
Michigan Tech University, Hougton