Orally Disintegrating Tablets in Fixed Dose Combination containing Ambroxol Hydrochloride and Salbutamol Sulphate prepared by Direct Compression Technique: Formulation Design, Development and In-Vitro Evaluation

Aim: The aim of the study deals with the formulation design, development and in-vitro evaluation of orally disintegrating tablets of ambroxol hydrochloride and salbutamol sulphate in combination for the treatment of respiratory disorders by using superdisintegrants in combination with suitable binder & excipients. Direct compression method was used to prepare tablets.
Material and Methods: In the present research work, the different concentrations of sodium starch glycolate (SSG) as superdisintegrant were used to optimize the concentration of SSG in the formulation of orally disintegrating tablets. Different concentrations of microcrystalline cellulose and PVP K-30 were also studied along with optimized SSG concentration. The tablets were evaluated for hardness, friability, weight variation, wetting time, in vitro disintegration time and % drug content uniformity. Optimized formulation was further evaluated by in-vitro release study, drug-excipient compatibility and accelerated stability study.
Result and Discussion: The optimized concentration of sodium starch glycolate was found to be 4% on the basis of lowest disintegration time. The 1% concentration of MCC was selected as optimum binder concentration on the basis of lowest disintegration time. Orally disintegrating tablets passed all the quality control tests viz., weight variation, hardness, friability, in-vitro disintegration time, drug content (%) and wetting time. The formulation satisfied the requirements of FDA for rapid dissolving tablets and allowed more than 85% drug to be released within 30 min. The FTIR study reveals that there was no interaction between drug and excipients. The accelerated stability study shows that formulation is quite stable at normal temperature and humidity conditions as well as at extreme temperature conditions.
Conclusion: It was concluded that by adopting a systematic formulation approach, ODT of ambroxol hydrochloride and salbutamol sulphate in fixed dose combination could be formulated using superdisintegrants in combination with appropriate binder & excipients which was found to be economical and industrially feasible.