SK. Arifa Begum

Pharmacovigilance is an integral part of clinical research. The potential awareness regarding adverse drug reactions has resulted in the emergence of the practice of Pharmacovigilance. Both clinical trials safety and post marketing pharmacovigilance are very significant in ensuring the drug safety. Pharmacovigilance methods can be categorized as Passive surveillance, Active surveillance, Comparative observational studies, targeted clinical investigations and Descriptive studies. The Central Drugs Standard Control Organization (CDSCO) already initiated a nationwide Pharmacovigilance programme under the aegis of Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare and Government of India. The pharmacovigilance system in India has to be refined with the collaboration of pharmacovigilance experts. Implementation of a robust pharmacovigilance program in India in accordance with the objectives and recommendations of World Health Organization by Central Drugs Standard Control Organization is a prerequisite. It is the need of the hour to improve communication between the healthcare professionals and the public; and educating the health professionals well to understand the benefits/ risks of medicines they prescribe. Developing own national database and sharing information with other regulatory agencies will contribute a lot of required information from worldwide data to take the correct decision on medicines and products.

In the present research work mucoadhesive microspheres of Cimetidine were prepared using Ionotropic gelation technique. All the microspheres were characterized for particle size, scanning electron microscopy, FT-IR study, DSC, percentage yield, drug entrapment, stability studies and for in vitro release kinetics and found to be within the limits. Among all the formulations M12 was selected as optimized formulation based on the physicochemical and release studies. In vitro drug release study of optimized formulation M12 showed 99.12% after 12 h in a controlled manner, which is essential for anti ulcer therapy. The innovator Cimetine conventional tablet showed the drug release of 96.15% within 1 h. The drug release of Cimetidine optimized formulation M12 followed zero order and Higuchi kinetics indicating diffusion controlled drug release.

The purpose of the research was to prepare and evaluate Roxatidine acetate HCl floating microspheres by ionotropic gelation method. Fourteen formulations were prepared, among all the formulations F13 was selected as optimized formulation based on the micromeretic and evaluation parameters including drug release studies. In the in vitro release study of formulation, F13 showed 95.65% drug release after 12 h in a controlled manner, which is desired for disease like peptic ulcer. In vitro release profiles from optimized formulation F13 were applied on various kinetic models. The best fit with the highest correlation coefficient was observed in zero order and Higuchi model, indicating diffusion controlled principle. The innovator Rotane 150 mg conventional tablet showed the drug release of 96.45% within 1 h. FT-IR and DSC analyses confirmed the absence of drug-polymer interaction. The results obtained from evaluation and performance study of different types of Roxatidine microspheres showed that system may be useful to achieve a controlled drug release profile, reduce the dose of drug, dosing frequency and improve patient compliance when compared with marketed product. Key words: Roxatidine, buoyancy, HPMC, gum olibanum, microspheres.