Original Articles
Nansri Saha Ghosh, Soumik Ghos
Abstract
The “objective” of this project work was to formulate a stable safe and effective film coated immediate release solid dosage form of “Ranitidine HCl” that spontaneously release the drug when expose into GIT for producing anti-ulcer effect. One of the major steps in formulation development activity is the development of “Film coating formulation and process” using hydroxy propyl methyl cellulose (HPMC-2208) and starch acetate film former. More particularly the dosage form is adapted for water soluble drugs and comprises a plurality of coated particles, wherein each has multiple layers about a core containing a drug active. The development of a tablet containing a moisture sensitive drug is subject to those high temperatures and high humidity during the film coating process. HPMC-2208 and starch acetate (SA) (50 : 50), used as an excipient for immediate release of drug, on the release profiles and bioavailability of the poorly water-soluble Ranitidine(RT) from a tablet. Although RT is a poorly water-soluble drug, it was rapidly dissolved from the RT-HPMC-SA and due to the improvement of its dissolution rate in the presence of HPMCand starch acetate. Analysis of parameters for diameter, thickness, average weight, hardness and uniformity of weight satisfies the limit of the specification for the immediate release formulation. Dissolution studies showed that all the three baches prepared having 98.9, 99.8 & 99.9 % dissolution for the Batch I, Batch II & Batch III respectively. The “scope” of this dissertation work is to maintain the solubility, dissolution and disintegration rate to probably improve oral bioavailability of the drug for producing process therapeutic effect