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

Abstract

ÖZAmaç: Solunum bozukluklarının tedavisi için oral-dağılan AMB hidroklorür ve salbutamol sülfat kombinasyon tabletlerinin (ODT) geliştirilmesi ve kombine süper dağıtıcıların uygun bağlayıcı ve eksipiyanlar ile kombine kullanımı ile in vitro değerlendirmenin yapılmasıdır. Tabletleri hazırlamak için doğrudan basım kullanıldı. Gereç ve Yöntemler: Bu araştırmada, oral dağılan tabletlerin formülasyonunda SNG konsantrasyonunu optimize etmek için farklı SNG konsantrasyonları süper dağıtıcı olarak kullanıldı. Farklı konsantrasyonlarda MCC ve PVP K-30 da optimize SNG konsantrasyonu ile birlikte çalışıldı. Tabletler, sertlik, Objectives: To design a formulation and develop ODTs of AMB hydrochloride and salbutamol sulphate in combination for the treatment of respiratory disorders and perform an in vitro evaluation using superdisintegrants in combination with a suitable binder and excipients. Direct compression was used to prepare the tablets. Materials and Methods: In the present research work, different concentrations of SSG as a superdisintegrant were used to optimize the concentration of SSG in the formulation of ODTs. Different concentrations of MCC and PVP K-30 were also studied along with the optimized SSG concentration. The tablets were evaluated for hardness, friability, weight variation, wetting time, in vitro DT, and percentage drug content uniformity. The optimized formulation was further evaluated in an in vitro release study, and drug-excipient compatibility and accelerated stability study. Results: The optimized concentration of SSG was found as 4% on the basis of the lowest DT. The 1% concentration of MCC was selected as the optimum binder concentration on the basis of the lowest DT. ODTs passed all the quality control tests viz., weight variation, hardness, friability, in vitro DT, drug content (%) and wetting time. The formulation satisfied the requirements of the FDA for rapid-dissolving tablets and allowed more than 85% drug to be released within 30 min. The fourier transform infrared spectroscopy study revealed that there was no interaction between the 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: By adopting a systematic formulation approach, ODTs of AMB hydrochloride and salbutamol sulphate in fixed-dose combination can be formulated using superdisintegrants in combination with appropriate binder and excipients; this was found to be economical and industrially feasible.

Comprehensive evaluation of extemporaneous preparation containing ambroxol HCl and salbutamol sulfate: Compatibility, chemometrics, and stability study

“…These FTIR spectra showed similar profiles with few variations at the wavenumber range of 900-600 cm −1 indicating the presence of drug excipients (Aminu et al, 2021). However, the FTIR profiles of the sample showed were similar compared to the FTIR spectra of a fixed-dose combination containing ambroxol hydrochloride and salbutamol sulfate prepared by direct compression in the previous study (Sharma et al, 2018).…”