INFLUENCE OF DRUG SOLUBILITY AND POLYMERS SUPPLY SOURCE ON THE PHYSICAL PERFORMANCE OF MATRIX TABLETS Original Article MUSTAFA E. MUSTAFA 1 , ABUBAKR O. NUR *2 , ZUHEIR A. OSMAN 2 , SARA A. AHMED 2 1 Department of Pharmaceutical Sciences, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, 2 Received: 29 Aug 2014 Revised and Accepted: 29 Sep 2014 Department of Pharmaceutics, Faculty of Pharmacy, University of Khartoum. Email: aomohamed@uofk.edu ABSTRACT Objective: The aim of this study is to explore the possible effects of drug solubility and commercial supply sources of HPMC and PVP on physical properties of matrix tablets. Methods: Two different supply sources (A and B) for Hydroxy Propyl Methyl Cellulose (HPMC) as matrix forming polymer and Polyvinyl Pyrrilidone (PVP) as matrix supportive polymer were used with either Chlorphenaramine maleate (CPM), as a water soluble drug or Atenolol (ATN), as a water insoluble drug, to produce a series of matrix formulations using direct compression according to a 2 3 Results: Matrix hardness and friability properties demonstrated to be influenced by PVP supply source as an individual factor alone or in combination with drug solubility factor, moreover, both properties were found to be less affected by drug solubility and HPMC supply source, as individual factors. Compared to other factors, drug solubility was found to have a substantial influence on drug dissolution efficiency (DE) and diffusion exponent of the drug release (n) of different matrices. full factorial design. Matrices were then qualified for friability, hardness, and drug release attributes. Conclusion: Variation in commercial PVP supply source and drug solubility could possibly result in matrices with different physical performance. Keywords: Drug solubility, HPMC supply source, PVP supply source, Matrix hardness, Matrix friability, Matrix release. INTRODUCTION Polymers are substances or materials that have a high molecular weight and consisting of repeated units named as monomers. Pharmaceutical applications of polymers are numerous and cover a wide range of utility [1,2]. This might be attributed to their biodegradability, pharmacological inertness, compatibility and low cost. The wide range of physicochemical properties offered by these materials may be utilized to improve both the clinical and non clinical (e. g., manufacturing, stability) properties of dosage forms. Polymers can be categorized into two classes, water soluble (hydrophilic) and water insoluble (hydrophobic) polymers. Hydroxypropyl methyl cellulose (hypromellose, HPMC) is a hydrophilic polymer available in several grades that vary in viscosity and extent of substitution. It is widely used in oral, ophthalmic and topical pharmaceutical formulations [3]. Polyvinylpyrrolidinone (PVP) is a hydrophilic polymer available in several grades. In addition to utilization of PVP in tablets production, it is used as a suspending, stabilizing, or viscosity increasing agent in a number of topical and oral suspensions and solutions. Incorporation of a drug in a polymeric matrix is one of the methods to develop controlled release dosage forms. The widespread application of the matrix as a dosage form for non conventional drug delivery is attributed to simplicity, versatility and reproducibility of its fabrication method. Numerous researches dealing with the pharmaceutical application of HPMC in matrices for sustained release drug delivery have been reported [4-6] and addition of PVP-K30 in HPMC-based matrix is believed to support the matrix for constant drug release through enhancing swelling-erosion balance of the matrix [7]. Many factors have been reported to affect the performance and drug release of matrix tablets [8,9]. However, the individual or mutual influences of drug solubility and the commercial supply source of polymers on matrix performance have received less attention among formulation scientists. The objective of this study is to explore the possible effects of drug solubility and supply source of included polymers (HPMC K4M and PVP K-30) on the characteristics of matrix tablets using Atenolol and Chlorpheneramine maleate as sparingly and free water soluble model drugs, respectively. MATERIALS AND METHODS Materials The following materials were used as received: Hydroxypropylmethylcellulose (HPMC K4M 4000 cps, pharmaceutical grade) was obtained from two different supply sources, A and B. Polyvinyl pyrrolidone (PVP K-30, pharmaceutical grade) was obtained from the same two different supply sources of HPMC (A and B) and were Magnesium stearate (Mg stearate) was a product of Huzhou donated by Amipharma Laboratories Ltd. (Sudan) and Citypharm Pharmaceutical Industries (Sudan), respectively. Zhanwang Pharmaceutical Co., Ltd. (China) and was donated by Shanghai-Sudan Pharmaceutical Model drugs used in this study (Chlorpheniramine Maleate and Atenolol) were pharmaceutical grade products of Co., Ltd. (Sudan). Supriya Chemicals Experimental design Pvt. Ltd and Ipca Laboratories Ltd (Mumbai, India), respectively, and were received as gift samples from Amipharma Laboratories Ltd. (Sudan). Other materials and reagents were analytical grade obtained from different commercial sources. Fabrication of formulations and screening within this study were conducted following 2 3 full factorial screening design (Table 1) where three variables, namely, supply source of HPMC, supply source of PVP k-30 and drug solubility were each examined at two possible levels to determine their effects on the physical performance of produced matrices through 8 experimental runs as presented in Table 1. International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 6, Issue 10, 2014 Innovare Academic Sciences