Preformulation studies of Glipizide: First step towards developing stable Osmotic Drug Delivery System

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.

Design Formulation and in vitro Evaluation of Gastroretentive Microspheres of Selegiline Hydrochloride for Parkinson’s Disease by Design Expert

“…Preformulation studies offer the required details to determine the nature of the drug substance and provide a framework for combining the drug with pharmaceutical excipients to develop a dosage form. [16][17][18]…”

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“…Hypertension is common and a leading cause of stroke and to a lesser extent, ischemic heart disease 5, 6 . Preformulation Study: Investigation of a drug substance's physical and chemical properties alone and when combined with excipients for biopharmaceutical, physicochemical and analytical inquiry to support potential trial formulations by determining the compatibility of first excipients with the active component 7,8,9 . The drug's organoleptic properties, such as colour, odour and taste, were observed, and the melting point was determined using the capillary method.…”