PREFORMULATION STUDY IN THE DEVELOPMENT OF A TABLET FORMULATION FOR THE TREATMENT OF ULCERATIVE COLITIS

Abstract

Ulcerative colitis (UC) is one of the inflammatory bowel diseases that lead to formation of ulcers or sores with
inflammation along the inside of the colon. The sores generated found to interfere with the normal digestive or
physiological processes. Drug administration through oral cavity is still highly preferred route in case of chronic conditions
where frequent dosing is required. Most of conventional formulations used in colon diseases showed low efficacy
associated with limited entry of drug at the site of action. Therefore amount and rate of drug that reaches the site of action is
the key factor in the management of UC. The selection of drug depends on its physicochemical properties along with its
compatibility with excipients to be used in the formulation. Therefore, the present research was aimed to study the
preformulation parameters for selected drug (Mesalamine) along with its compatibility profile. This data could help in
development of the site specific drug delivery system for an effective treatment of UC. In preformulation studies several
parameters have been investigated such as solubility, particle size, density, flowability, assay and loss on drying content and
drug-excipient compatibility. Mesalamine was found to be compatible with excipients used in formulation. The drug
showed good flowability as well as considerable stability.