Modified release capsules of Ambroxil, Preformulation and evaluation

The aim and objectives of the present study was to develop a pharmaceutically equivalent, stable, cost effective and quality improved formulation of Ambroxol pellets to present it in the form of capsules (Modified release capsules). To achieve this goal various prototype formulation trails were taken and evaluated with respect to the various quality control such as dissolution, assay, acid resistance and moisture content. The active pharmaceutical ingredient Ambroxol was subjected to preformulation study, and the results obtained with selected excipients showed good compatibility with Ambroxol. Ambroxol coated pellets were formulated by using commercially available pellets and Ambroxol coated pellets were filled by capsule filling machine. The stability of the capsules and pellet was determined by conducting “Accelerated stability testing” in 40°C ± 2°C / 75% ± 5%RH, 30ºC ± 2 ºC/ 65% ± 5% RH and 25±2°C/60±5% RH conditions for 1 month. Finally, after the duration, the product was analyzed for content and dissolution study. By the stability studies, the formulated Ambroxol modified release capsules and pellets proved to be stable throughout the period of the storage. The Ambroxol modified release pellets were loaded in size 4 capsules. It showed good results in formulation of stable dosage. Modified release pellets have minimum volume in size, greater surface area and more surface of disintegration time for pellets in capsules. Small volumes of pellets enter into the systemic circulation very fast. Moreover no accumulation of drug in the body occurs.

Author(s): Abdul Althaf. S, Venkateswarulu. Y and Umal Khair. S.

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