This present work aimed to mask the bitter taste of Ambroxol hydrochloride and formulate it into a patient-friendly dosage form. The use of solid dosage forms can pose significant administration challenges in children, mentally challenged and uncooperative patients. To overcome this challenge, a complexation technique using KYRON -T-114, an ion-exchange resin, was used to mask the bitter taste. The drug loading onto the ion-exchange resin was optimized for the drug to resin, effect of pH, and effect on soaking time. The resinate was evaluated for taste masking and characterized by FT-IR and DSC.
The taste-masked drug was then formulated into a fast-dissolving tablet (FDT), which was evaluated for various parameters such as hardness, friability, drug content, weight variation, content uniformity, friability, water absorption ratio, in-vitro disintegration time, and in-vitro drug release studies. IR and DSC spectra revealed no possible interactions between the drug and polymer.
Maximum loading was obtained at a drug-resin ratio of 1:2, pH 7, and soaking time of 30 minutes. A successful taste masking of resinate was confirmed by the time intensity method. The data obtained from post-compression parameters was superior to conventional formulation. The F3 batch with a disintegration time of 30.4±0.64 sec and dissolution of 98.4±2.69 was selected as the optimized formulation.
The optimized formulation was compared with the traditional marketed formulation and was found superior. The results revealed that Ambroxol hydrochloride had been successfully taste-masked and formulated into an FDT as a suitable alternative to traditional tablets. Overall, the study successfully demonstrated the feasibility of developing a patient-friendly dosage form for Ambroxol hydrochloride.
Author(s) Details:
Bimal Debbarma,
Institute of Pharmacy, Assam Don Bosco University, Tapesia, Assam-782402, India.
Please see the link here: https://stm.bookpi.org/ACPR-V4/article/view/12926
Keywords: Ambroxol hydrochloride, KYRON -T-114, taste masking, sodium starch glycolate, crospovidone