Formulation and Evaluation of Medicated Chewing Gums of Chlorpheniramine Maleate

The aim of the present work is development and evaluation of Chlorpheniramine maleate medicated chewing gums and to study the influence of different plasticizers on physicochemical parameters and in vitro drug release profile. Chlorpheniramine maleate is used to relieve symptoms of allergy, hay fever and common cold. Prepared formulations are evaluated for thickness, hardness, weight variation, friability, drug content and drug-excipient interactions. In vitro drug release was performed by modified dissolution apparatus. Better consistency of formulation and faster release of drug was obtained with glycerol (F6) & castor oil (F12). In all formulations, when concentration of plasticizers increases, increased drug release is observed. The formulations prepared with glycerol as a plasticizer i.e., F6 shows good drug release compared to formulations prepared with castor oil. Koppula. Rajitha 1 *, Yamsani. Madhusudhan Rao 2 1 Department of Pharmaceutics, St. Peters Institute of Pharmaceutical Sciences, Hanamkonda, Warangal, TG 2 Department of Pharmaceutics, Vaagdevi College of Pharmacy, Naimnagar, Warangal, TG, India. Submission: 29 April 2016 Accepted: 5 May 2016 Published: 25 May 2016 www.ijppr.humanjournals.com Citation: Koppula. Rajitha et al. Ijppr.Human, 2016; Vol. 6 (2): 72-79. 73 INTRODUCTION Oral route is the most preferred route amongst the patient and clinicians due to various advantages it offers. Man has a habit of chewing the chewing gum since ancient times. Today it is one of the most popular dosage form, used for delivering the many active components [1] . Medicated chewing gum is solid, single-dose preparations that have to be chewed and not swallowed; chewing gums contain one or more active ingredient that is released by chewing [2,3] . Medicated chewing gum offers a highly convenient patient–compliant way of dosing medications, not only for special population groups with swallowing difficulties such as children and the elderly but also for the general population including the young generation. Various excipients used in the manufacture of chewing gums like elastomers, elastomer solvents, bulking agents, softening agents, sweetening agents, flavouring agents, antioxidants, glidants [4,5,6] . Medicated chewing gums are prepared by different methods like conventional/traditional method, cooling and grinding method and direct compression method [7, 8]. Chlorpheniramine maleate is used to relieve symptoms of allergy, hay fever and common cold. It has poor oral bioavailability as it undergoes extensive first pass hepatic metabolism [9] . So it is a suitable candidate prepare into a medicated chewing gum. In this work, medicated chewing gum of chlorpheniramine maleate was prepared by direct compression method using different concentrations of plasticizers like glycerol and castor oil. MATERIALS AND METHODS Chlorpheniramine maleate was received as a gift sample from Meditab Ltd., India, Polyvinylpyrrolidone obtained from Bliss chemical & pharmaceuticals India Ltd.(Thane). Plasticizers and all other ingredients are obtained from S.D. Fine Chem. Ltd., Mumbai. Drug-Excipient Compatability Studies: FT-IR Studies: The drugexcipient compatibility study was carried out by FTIR (Bruker Alpha E Opus), FTIR spectra of pure drug and optimized formulation were recorded. The baseline correction was done by blank background and 400-4000 cm -1 was used as scanning range. www.ijppr.humanjournals.com Citation: Koppula. Rajitha et al. Ijppr.Human, 2016; Vol. 6 (2): 72-79. 74 Standard Graph for Chlorpheniramine maleate: 100 mg of drug was taken and placed in 100 ml of volumetric flask, 6.8 pH phosphate buffer was used to made the volume to 100 ml, which is equal to 1000 μg/ml, by using this stock solution prepare different dilutions from 10-50 μg/ml and the absorbance was recorded at 265 nm using U.V spectrophotometer. Preparation of chewing gum by direct compression method: Required quantities of drug, PVP, CaCo3 are taken into mortar and mixed. To this melted beeswax and plasticizers were added and mixed well. To this mixture remaining ingredients are added and compressed by using Rotary Tablet Compression Machine (Cadmach, Ahmedabad, India).