The Plackett-Burman model-An Improved Alternative to Identify the Significant Factors Implied in the Preparation of Tramadol Hydrochloride Microsphere

Abstract:

Background and Purpose: According to Process Analytical Technology perspective, drug product quality should be ensured by manufacturing process design. Initial step of the process analysis is investigation of critical process parameters (CPPs). Quality is considered to be the major tool in pharmaceutical industry and failures in the quality of upcoming new chemical entities have been seen in the recent years due to complications in the formulation process. This paper describes the use of Design of Experiments tool for selection of the CPPs. Methods: Albumin microspheres were prepared by heat denaturation method. Different factors like Drug Conc., amount of Tween, Glutaraldehyde conc., Stirring speed were selected as independent variables at two levels in the Plackett and Burman (PB) design. By using software the effect of different factors were studied. The microspheres were characterized for percentage burst effect, percentage encapsulation efficiency. Results: The CPPs affecting encapsulation efficiency were Drug Conc., amount of Tween, Glutaraldehyde conc., Stirring speed. FTIR study showed compatibility of the drug with excipients without having any significant interactions. Conclusion: The study concludes that the statistical PB design could be useful to identify influencing variables such as Drug Conc., amount of Tween, Glutaraldehyde conc., Stirring speed.

Key words: Microspheres, Plackett Burman design, Tramadol Hydrochloride (TH).