Research Journal of Pharmacy and Technology

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Preformulation Studies of Glipizide: First Step Towards Developing Stable Osmotic Drug Delivery System


Affiliations
1 Department of Pharmaceutics, School of Pharmacy, Dr. Vishwanath Karad, MIT World Peace University, Pune 411038, Maharashtra,, India
2 2Senior Research Associate, Wockhardt Research Center, Aurangabad, Maharashtra, India
3 Department of Pharmaceutics, Dr. D Y Patil Institute of Pharmaceutical Sciences and Research, Pimpri Pune, 411018, Maharashtra,, India
4 Department of Pharmacognosy, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra,, India
     

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Objective: The goal of this research study was to conduct a preformulation analysis of glipizide in order to establish a stable, robust as well as therapeutically effective system. Methods: Glipizide was characterized to determine its flow properties. Solubility was determined in different pH-varying solvents and its purity was determined by infrared spectrum and absorption maxima. Standard UV curve was developed to aid in further analytical research studies. Finally loss on drying (LOD) and drug-excipients compatibility tests were performed. Results: Glipizide has poor flow and compressibility properties (BD 0.222 g/ml, TD 0.425 g/ml, Carr’s index 47.78%, Hauser’s ratio 1.915). Solubility of drug was found to increase with increase in pH. The purity of drug was confirmed by infrared spectrum which showed characteristics peaks and by uv spectroscopy which exhibited maxima at 276 nm. The standard curve obtained was linear with correlation coefficient (R2 =0.998) and equation y = 0.0144x +0.0078. There were no drug excipient interactions which was clear as no visual changes in drug samples were observed with respect to discoloration, liquefaction and odor. Conclusion: The drug candidate under consideration was pure glipizide which had poor flow property suggesting use of granulation technique during tablet manufacturing and it was stable with selected excipient at reported ratio at 40oC / 75 % RH for 4 weeks.

Keywords

Preformulation, Glipizide, Drug characterization, Drug-excipients compatibility studies.
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  • Chaurasia G. A Review on Pharmaceutical Preformulation Studies in Formulation and Development of new Drug Molecules. Int J Pharm Sci Res. 2016; 7(6), 2313-2320.

  • Desu PK, Vaishnavi G, Divya K and Lakshmi U. An overview on preformulation studies. Indo American Journal of Pharmaceutical Sciences. 2015; 2(10): 1399-1407

  • Nandgude TD and Bhise KS. Characterization of drug and polymers for development of colon specific drug delivery system. Asian J Biomed Pharm Sci. 2011; 1: 17-21.

  • Nirav Patel, Nagesh C, Jinal Patel, Chandrashekhar S and Jani Devdatt. Formulation and Evaluation of Floating Tablet Containing Glipizide. Asian J. Pharm. Tech. 2012; 2(4): 135-140.

  • Sola D, Rossi L, Schianca GP, Maffioli P, Bigliocca M, Mella R, Corlianò F, Fra GP, Bartoli E and Derosa G. Sulfonylureas and their use in clinical practice. Arch Med Sci. 2015; 11(4): 840-848.

  • Wåhlin-Boll E, Almér L and Melander A. Bioavailability, Pharmacokinetics and Effects of Glipizide in Type 2 Diabetics. Clin Pharmacokinet. 1982; 7: 363–372.

  • Rakhi BS, Mobin AT and Mansoor AK. Comparative Evaluation of Flow for Pharmaceutical Powders and Granules. AAPS Pharm Sci Tech. 2008; 9: 250-258.

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  • More S, Nandgude T, Poddar S. Vesicles as a tool for enhanced topical drug delivery. Asian J Pharm. 2016; 10: 196-209.

  • Nandgude TD, Bhise KS and Gupta VB. Characterization of hydrochloride and tannate salts of diphenhydramine. Indian J Pharm Sci. 2008; 70(4): 482-486.

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  • Sopanrao Muley S, Nandgude T and Poddar S. Formulation and Optimization of Lansoprazole Pellets Using Factorial Design Prepared by Extrusion-Spheronization Technique Using Carboxymethyl Tamarind Kernel Powder. Recent patents on drug delivery & formulation. 2017; 11(1): 54-66.

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  • Prashant R, Rakesh M, Tanaji N and Sushilkumar P. Solubility and dissolution enhancement of albendazole by spherical crystallization. Asian journal of biomedical and pharmaceutical sciences. 2016; 6(52): 09-14.

  • Siya D, Sinai K, Shilpa B, Ajeet MG and Pankaj G. Biopharmaceutical Classification System: A Brief Account. International Journal of Research Methodology. 2017; 1(1): 20-46.

  • Ardita V, Simon Ž and Albin K. A review of methods for solubility determination in biopharmaceutical drug characterization. Drug Development and Industrial Pharmacy. 2019; 45(11): 1717-1724.

  • Prakash Goudanavar, Doddayya Hiremath, Spandana D and Reddy SR. Development and Evaluation of Fast Disintegrating Tablets of Granisetron HCl with Natural and Synthetic Polymers. Asian J. Pharm. Res. 2011; 1(3): 72-77.

  • Karkhanis VV, Captain AD and Patel PH. Development and Validation of UV Spectrophotometric method for estimation of Glipizide in Bulk and Pharmaceutical Dosage Forms. Int J Pharm Sci Res. 2013; 4(5): 1865-1867.

  • Asma Afroz, Tasnuva Haque, Mesbah Uddin Talukder and Ashraful Islam SM. Spectrophotometric Estimation of Rosuvastatin Calcium and Glimepiride in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2011; 1(4): 74-78.

  • Bogomolov A, Mannhardt J and Heinzerling O. Accuracy Improvement of In-line Near-Infrared Spectroscopic Moisture Monitoring in a Fluidized Bed Drying Process. Front Chem. 2018; 6: 388-398.

  • Ragade SM, Bari MM and Barhate SD. Formulation and Evaluation of Candesartan Cilexetil Mouth Dissolving Tablet by using Natural Superdisintegrant. Asian J. Pharm. Res. 2018; 8(3): 136-144.

  • Kumaraswamy G, Gandla Lalitha, Swetha K, Suthakaran R and Ramesh Babu G. A Validated RP-HPLC Method for Simultaneous Estimation of Pseudoephedrine and Terfinadine in its Bulk and Pharmaceutical Dosage forms. Asian J. Pharm. Tech. 2014; 4(4): 200-204.

  • Shivram K, Patil DM, Shah ND, Thite RU, Joshi AS and Motka NP. An Unrealistic Drift in Assay on Anhydrous Basis towards Content Limit. Indian J Pharm Sci. 2009; 71(6): 679-684.

  • Srinivasarao K, Adithya B, Sandeep I, Sankeerth PT, Teja D, Manikiran S and RamaRao N. An Overview on Preformulation for Pharmaceutical Product Development and Drug Excipient Incompatibility Studies. International Journal of Pharma and Chemical Research. 2017; 3(2): 354-368

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  • Hemant Patel. Study of Different Granulation Processes during Formulation Development, Evaluation, Characterization of Granules and Capsule Formulations. Asian J. Pharm. Res. 2014; 4(2): 92-113.

  • Krishna Reddy Y and Nagaraju A. Formulation and In vitro Evaluation of Sustained Release Matrix Tablet of Azathioprine. Asian J. Pharm. Tech. 2020; 10(2): 65-70.


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  • Preformulation Studies of Glipizide: First Step Towards Developing Stable Osmotic Drug Delivery System

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Authors

Manish Wani
Department of Pharmaceutics, School of Pharmacy, Dr. Vishwanath Karad, MIT World Peace University, Pune 411038, Maharashtra,, India
Pradeep Rodge
2Senior Research Associate, Wockhardt Research Center, Aurangabad, Maharashtra, India
Akshay Baheti
Department of Pharmaceutics, School of Pharmacy, Dr. Vishwanath Karad, MIT World Peace University, Pune 411038, Maharashtra,, India
Satish Polshettiwar
Department of Pharmaceutics, School of Pharmacy, Dr. Vishwanath Karad, MIT World Peace University, Pune 411038, Maharashtra,, India
Tanaji Nandgude
Department of Pharmaceutics, Dr. D Y Patil Institute of Pharmaceutical Sciences and Research, Pimpri Pune, 411018, Maharashtra,, India
Firoj Tamboli
Department of Pharmacognosy, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra,, India

Abstract


Objective: The goal of this research study was to conduct a preformulation analysis of glipizide in order to establish a stable, robust as well as therapeutically effective system. Methods: Glipizide was characterized to determine its flow properties. Solubility was determined in different pH-varying solvents and its purity was determined by infrared spectrum and absorption maxima. Standard UV curve was developed to aid in further analytical research studies. Finally loss on drying (LOD) and drug-excipients compatibility tests were performed. Results: Glipizide has poor flow and compressibility properties (BD 0.222 g/ml, TD 0.425 g/ml, Carr’s index 47.78%, Hauser’s ratio 1.915). Solubility of drug was found to increase with increase in pH. The purity of drug was confirmed by infrared spectrum which showed characteristics peaks and by uv spectroscopy which exhibited maxima at 276 nm. The standard curve obtained was linear with correlation coefficient (R2 =0.998) and equation y = 0.0144x +0.0078. There were no drug excipient interactions which was clear as no visual changes in drug samples were observed with respect to discoloration, liquefaction and odor. Conclusion: The drug candidate under consideration was pure glipizide which had poor flow property suggesting use of granulation technique during tablet manufacturing and it was stable with selected excipient at reported ratio at 40oC / 75 % RH for 4 weeks.

Keywords


Preformulation, Glipizide, Drug characterization, Drug-excipients compatibility studies.

References