Formulation Development and Evaluation of Fast Disintegrating Tablets of Ambroxol Hydrochloride for Pediatrics- A Novel Approach for Drug Delivery

Abstract:

Objective: The objective of the present study was to prepare the fast disintegrating tablet of Ambroxol Hydrochloride for respiratory disorders such as bronchitis, asthma and cough for pediatrics. Material and Methods: The tablets were prepared by direct compression technique. Superdisintegrants such as Sodium Starch Glycolate was optimized. Different binders were optimized along with optimized superdisintegrant concentration. The tablets were evaluated for hardness, friability, weight variation, wetting time, disintegration time and uniformity of drug content. Optimized formulation was further evaluated by in-vitro dissolution test, drug-excipient compatibility and accelerated stability study. Results: Sodium Starch Glycolate was optimized as 4% for formulation on the basis of least disintegration time. 1% Microcrystalline Cellulose was selected as optimum binder concentration on the basis of least disintegration time. Percent weight variation and content uniformity was well within the acceptable limit. The friability was less than 1%. The wetting time and disintegration time was practically good for all formulations. The results obtained with FTIR studies and accelerated stability study showed that there was no interaction between the drug and excipients used in the formulation. Conclusion: It was concluded that by employing commonly available pharmaceutical excipients such as superdisintegrants, hydrophilic and swellable excipients and proper filler a fast disintegrating tablet of Ambroxol Hydrochloride for pediatrics used in respiratory disorders were formulated successfully with desired characteristics which disintegrated rapidly; provide rapid onset of action and enhance the patient convenience and compliance.

Key Words: Ambroxol Hydrochloride, Fast disintegrating tablet, Sodium starch glycolate, Optimization study, In-vitro Disintegration time.