Optimization Techniques in Designing of Pharmaceutical Dosage Form

About author
R.T. Dolas*, S.S Siddheshwar, S.B. Somwanshi, A.N. Merekar, R.K. Godge, S. R. Pattan
Department of Pharmaceutics, P.R.E.S.’s, Pravara Rural College of Pharmacy, Loni.
Department of Pharmaceutical Chemistry, P.R.E.S.’s, Pravara Rural College of Pharmacy, Loni.
E-mail: [email protected]

Abstract
Pharmaceutical dosage form design and development usually involves multiple objectives. In past, this task has been through trial and error, supplemented by the previous experience, knowledge and wisdom of the formulator. The final product may be satisfactory but sub-optimal, as a better formulation might still exist for the studied conditions by using traditional approach. Thus, in the traditional approach the primary aim of the formulator may not be in designing the best formulation, but finding a suitable solution under the given set of restrictions. These drug product inconsistencies are generally due to inadequate knowledge of causal factor and response relationship. Nowadays, systematic approaches, usually called as optimization techniques, are being widely practiced to alleviate such inconsistencies. In the present article the insight of optimization techniques is given with respect to its comparison with traditional approach, fundamental concepts, mathematical model, graphic presentation of optimization results, optimization methodologies etc.
Key word: Optimization, dosage form, approach. 
Introduction
Dosage Form Design: Traditional Vs Systematic Approach
Design and development of an immaculate drug product or pharmaceutical process usually involves multiple objectives under its ambit. For decades, this task has been endeavored through trial and error, supplemented by the previous experience, knowledge and wisdom of the formulator. The modification of a formulation is carried out by the analysis of its composition and influence of process factors on dosage form characteristics, changing any one at a time. Using this approach, the solution of a specific problematic property can be achieved, but attainment of the true optimum composition or process can never be guaranteed. The final product may be satisfactory but sub-optimal, as a better formulation might still exist for the studied conditions. Thus, in the traditional approach the primary aim of the formulator may not be in designing the best formulation, but finding a suitable solution under the given set of restrictions. The aforementioned drug product inconsistencies are generally due to inadequate knowledge of causal factor and response relationship. Nowadays, systematic approaches, usually called as optimization techniques, are being widely practiced to alleviate such inconsistencies. These encompass experimental designs, mathematical equations and graphic outcomes, depicting a complete picture of variation of the response as a function of the factor. Systematic approaches are thus far more advantageous, possess greater benefits and overcome various pitfalls inherent to the traditional approaches as these are require fewer experiments to achieve an optimum formulation, reveal interactions, yield the best solution in the presence of competing objectives, make problem tracing and rectification quite easier, simulate the product or process performance using model equation, comprehend the process to assist in formulation development and subsequent scale-up.