Article

Optimization and Development of Swellable Controlled Porosity Osmotic Pump Tablet for Theophylline

Tropical Journal of Pharmaceutical Research (ISSN: 1596-5996) Vol 8 Num 3 01/2009;
Source: OAI

ABSTRACT Purpose: To develop swellable controlled porosity osmotic pump tablet of theophylline and to define the formulation and process variables responsible for drug release by applying statistical optimization technique. Methods: Formulations were prepared based on Taguchi Orthogonal Array design and Fraction Factorial design for core and coating, respectively. The tablets were prepared by direct compression and wet granulation methods; spray coated with ethyl cellulose solution containing varying amounts of PEG 400 and plasdone. Drug release from the osmotic drug delivery system was studied using USP Type I paddle type apparatus. The membrane morphology of the delivery system was determined by scanning electron microscopy (SEM). Results: Optimization results indicated that the release rate of theophylline from the swellable controlled porosity osmotic pump tablet is directly proportional to the levels of osmotic agent, solubilizing agent and pore former in the tablet core and the membrane, respectively. SEM showed the formation of pores in the membrane through which drug release occurred. The best formulation showed 98.2 % drug release and complied with USP requirements. Conclusion: The results confirmed that the factors responsible for drug release were osmotic agents (core) and pore former (membrane). Also, the preparation of swellable controlled porosity osmotic pump tablet was facilitated by coating the core tablet with pore forming agent, thus eliminating the need for the more expensive laser drilling.

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    ABSTRACT: Extensive research into circadian rhythms and their influence on biological systems has given rise to the science of chronobiology and subsequently chronotherapy, the science of delivering drugs in synchrony with biological rhythms. The field of chronotherapeutics paves the way for advances and complexities in current drug delivery technology. The ultimate goal of current chronopharmaceutical research strives to design ideal chronotherapeutic drug delivery systems that respond to such therapeutic needs. Considering the fact that physiological events such as heart rate, blood pressure, plasma concentration of hormones, plasma proteins and enzymes display constancy over time, drug delivery systems with constant release profiles have thus been favored. However, due to circadian rhythms, the conventional paradigm of constant drug delivery may not be what is needed. Instead, precisely timed drug delivery systems are required in order to correlate drug delivery with circadian rhythms to provide maximum therapeutic efficacy for chronotherapeutic diseases when most needed. The aim of this review paper is to outline the concepts in designing chronopharmaceuticals from a clinical viewpoint of major chronotherapeutic diseases such as asthma, allergic rhinitis, cardiovascular disorders, rheumatoid arthritis and cancer as well as relatively minor niche areas of interest such as in glaucoma, diabetes, immunity, pain, gastric ulcers, epilepsy and even HIV/AIDS that would require chronotherapy. In addition this review paper attempts to concisely assimilate and explicate the role of circadian rhythms in these various disease states and provide a focused overview of the current state-of-the-art in designing strategies for chronopharmaceutical formulations employed for treating chronotherapeutic diseases.
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