Asian Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Formulation Optimization and Evaluation of Push Pull Osmotic Pump Tablet of Vildagliptin


Affiliations
1 Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner, Dist - Jalgaon, Maharashtra, 424206, India
2 Medley Pharmaceuticals Ltd., Andheri (East), Mumbai - 400 093, Maharashtra, India
     

   Subscribe/Renew Journal


Purpose- The present study was to develop an oral push-pull osmotic pump tablet of vildagliptin, DPP-IV inhibitor drug; which is BCS class I drug. Method- The tablets were prepared by the wet granulation method using polyox and osmotic agent NaCl. The granules were compressed into bilayered tablet by conventional compression machine. The bilayered core osmotic tablets were coated with cellulose acetate in a conventional pan coating. In-vitro dissolution was evaluated using USP dissolution apparatus II in 0.1 N HCl pH 1.2 buffers for 2 hrs and phosphate buffer pH 7.5 for 22 hrs respectively. The formulated optimized batch VP1 were kept to stability studies for 3 months. Result- The formulated optimized batch VP1 of PPOP tablet shows 2hrs lag time with zero order release kinetic. In –vitro drug release was obtained 91.45 % up to 22hrs respectively. Polyox in push-pull layer along with osmotic agent and cellulose acetate controlled the drug release pattern from formulated PPOP tablet. No significant changes were observed upto the period of 3 months of storage during stability study. Conclusion- The PPOP tablet of vildagliptin was able to deliver the drug in controlled pattern over a long period of time by the process of osmosis. Conventional compression and pan coating method can be used to prepare PPOP tablet successfully.

Keywords

PPOP, Bilayered Tablet, Polyox, Sodium Chloride, Vildagliptin, Cellulose Acetate, Factorial Design
Subscription Login to verify subscription
User
Notifications
Font Size


  • Hong Wen, Kinnam Park. Oral Controlled Release Formulation Design and Drug Delivery; Theory to Practice. 1st Edition, Wiley-Blackwell, 127-152, 2010.

  • Jain NK. Advance in Controlled and Novel Drug Delivery. 1st edition, CBS Publisher and Distributor, New Delhi: 18-37, 1997.

  • Vincent Malaterre, Joerg Ogorka, Nicoletta Loggia, Robert Gurny. Evaluation of the Tablet Core Factors Influencing the Release Kinetics and the Loadability of Push–Pull Osmotic Systems.Drug Development and Industrial Pharmacy, 1–7, 2008.

  • https://pubchem.ncbi.nlm.gov/compound/vildagliptin.

  • http://www.drugbank.ca/drugs/DB04876.

  • Bolton Sanford. Pharmaceutical Statistic. 3rd edition, James Swarbrick, North Carolina: 336-394.

  • Jain NK. Pharmceutical Product Development. 2nd edition, CBS Publisher and Distributor Pvt, Ltd, New Delhi: 369-394.

  • Varsha B. Pokharkar, Prathmesh P. Kenjale, Manjusha A. Joshi, Umesh N. Khataver, Vividha V. Dhapte. Paroxetine Hydrochloride Push-Pull Osmotic Pump Tablets: Designing an Innovative, Scalable Push-Pull Osmotic Drug Delivery System Using Qbd Approach. Drug Delivery Letters, Vol. 10, Issue 2: 104-116, 2020.

  • Pooja V. Kadu, Kailas N. Tarkase. Formulation Development Evaluation of Bilayer Push Pull Osmotic Pump Tablet of Atenolol Using 32 Factorial Design. International Journals of Drug Research and Technology, ISSN: 2277-1506 Vol. 6(3), 150-163.

  • Gus LaBella, Manish Rane, and Piyush Patel The Influence of Manufacturing Method on Physical Properties and Drug Release from Push-Pull Osmotic Pump (PPOP) Products, Colorcon, Inc., Harleysville, PA USA, 2014.

  • Bhairav Bhushan A, Wagh Yogesh B, Saudagar Ravindra B. Formulation and Evaluation of Push-Pull Osmotic Tablet of Cyproheptadine Hydrochloride. World Journal of Pharmaceutical Research, ISSN 2277– 7105, Volume 5, Issue 7, 1810-1829.

  • Sanford Bolton, Charles Bon, Pharmaceutical Statistics Practical and Clinical Applications. Fourth Edition, Revised and Expanded. Marcel Dekker INC; New York Basel volume 135,551-558.

  • Shahrzad Missaghi, Piyush Patel, Thomas P. Farrell, HiepHuatan and Ali R. Rajabi-Siahboomi. Investigation of Critical Core Formulation and Process Parameters for Osmotic Pump Oral Drug Delivery. AAPS Pharm SciTech, Vol. 15, No. 1, 169-160, February 2014.

  • Wei Li, Gani Du, Xinggang Yang, Zhihong Zhang, ShufangNie, Bo Peng and Weisan Pan, In Vitro And In Vivo Evaluation of A Novel Push–Pull Osmotic Pump with Orifices on Both Side Surfaces, Drug Development and Industrial Pharmacy. ISSN: 0363-9045,1350-1355.

  • Xiaohong Liua, Shang Wanga, Liqing Chaiab, Dong Zhanga, Yinghua Suna, Lu Xuc, Jin Suna. A Two-Step Strategy to Design High Bioavailable Controlled-Release nimodipine Tablets: The Push–Pull Osmotic Pump in Combination with the Micronization/Solid Dispersion Techniques. International Journal of Pharmaceutics. 529– 539.

  • Brahmankar DM, Jaiswal SB. Biopharmaceutics and Pharmacokinetic- A Treatise, 3rdedition, Vallabh Prakashan, Delhi: 434-436.2015.

  • Bhavana Habib, Jyoti Mittha. Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets. Asian Journal of Pharmaceutical Analysis. 2021; 11(4):255-8.

  • Vaishali V. Karkhanis, Anandkumari D. Captain. Development and Validation of a Liquid Chromatographic Method for Estimation of Vildagliptin in Tablet Dosage Form. Asian J. Research Chem. 6(12): December 2013; Page 1166-1168.

  • Hindustan Abdul Ahad, HaranathChinthaginjala, Syed Rahamtulla, Barji Prasanna Pallavi, ChakaliShashanka, JangamPrathyusha. A Comprehensive report on Solid Dispersions by Factorial Design. Asian Journal of Research in Chemistry. 2021; 14(4):297-1.

  • R. Sakthikumar, R. Lathaeswari, R. Senthamarai, T.N.K. Suriyaprakash, A. Anithaa. Formulation and Evaluation of Propanolol HCl Controlled Porosity Osmotically Controlled Tablet. Research J. Pharma. Dosage Forms and Tech. 2010; 2(6): 378-380.

  • A. Ankarao, CH. Babu Rao, N. Devanna. Formulation and Evaluation of Buccoadhesive Bilayered Tablets of Terbutaline Sulphate. Research J. Pharma. Dosage Forms and Tech. 2012; 4(1):32-35.

  • D. Varun, B.V.P. Deepthi, P.V. AyodhyaNeelima, G. Suma Latha, M. Srikar, B. Anuhya, V. Siva Lalitha. Formulation and In Vitro Assessment of Controlled Release Matrix Tablets of Abacavir. Research J. Pharma. Dosage Forms and Tech. 2011; 3(6): 298-303.

  • Satish K Mandlik, DS Nandare, MM Joshi, PD Chudiwal, KS Jain. Statistical Optimization of Orodispersible Tablets Containing Telmisartan Using Factorial Design and Response Surface Methodology. Research J. Pharm. and Tech. 2 (3): July-Sept. 2009; Page 548-551.

  • Loujain Anis Dayoub, FidaAmali. Development of a new visible Spectrophotometric analytical method for determination of Vildagliptin in Bulk and Pharmaceutical Dosage Forms. Research J. Pharm. and Tech. 2020; 13(6): 2807-2810.

  • Vaishali P. Patel, Krishna A. Bhatt, Mrunali M. Shah, Dharti M. Patil, Rakshita S. Patel, Divya M. Desai, Prachi H. Parmar. Development and Validation of Spectrophotometric Estimation of Vildagliptin through Oxidative Coupling Reaction using MBTH Reagent in Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2021; 14(1):62-66.

  • D. Gnanasekaran, R. Gandhimathi. Quantification of Novel Dpp4 Inhibitor-Vildagliptin by Spectrophotometric and Chromatographic Techniques: Brief Review. Research Journal of Pharmacy and Technology. 2021; 14(10):5603.


Abstract Views: 66

PDF Views: 0




  • Formulation Optimization and Evaluation of Push Pull Osmotic Pump Tablet of Vildagliptin

Abstract Views: 66  |  PDF Views: 0

Authors

M. M. Bari
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner, Dist - Jalgaon, Maharashtra, 424206, India
Ashwini V. Patil
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner, Dist - Jalgaon, Maharashtra, 424206, India
R. J. Ubhale
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner, Dist - Jalgaon, Maharashtra, 424206, India
S. D. Barhate
Department of Pharmaceutics, Shree Sureshdada Jain Institute of Pharmaceutical Education and Research, Jamner, Dist - Jalgaon, Maharashtra, 424206, India
Mohd Nasir
Medley Pharmaceuticals Ltd., Andheri (East), Mumbai - 400 093, Maharashtra, India

Abstract


Purpose- The present study was to develop an oral push-pull osmotic pump tablet of vildagliptin, DPP-IV inhibitor drug; which is BCS class I drug. Method- The tablets were prepared by the wet granulation method using polyox and osmotic agent NaCl. The granules were compressed into bilayered tablet by conventional compression machine. The bilayered core osmotic tablets were coated with cellulose acetate in a conventional pan coating. In-vitro dissolution was evaluated using USP dissolution apparatus II in 0.1 N HCl pH 1.2 buffers for 2 hrs and phosphate buffer pH 7.5 for 22 hrs respectively. The formulated optimized batch VP1 were kept to stability studies for 3 months. Result- The formulated optimized batch VP1 of PPOP tablet shows 2hrs lag time with zero order release kinetic. In –vitro drug release was obtained 91.45 % up to 22hrs respectively. Polyox in push-pull layer along with osmotic agent and cellulose acetate controlled the drug release pattern from formulated PPOP tablet. No significant changes were observed upto the period of 3 months of storage during stability study. Conclusion- The PPOP tablet of vildagliptin was able to deliver the drug in controlled pattern over a long period of time by the process of osmosis. Conventional compression and pan coating method can be used to prepare PPOP tablet successfully.

Keywords


PPOP, Bilayered Tablet, Polyox, Sodium Chloride, Vildagliptin, Cellulose Acetate, Factorial Design

References