Formulation and Evaluation Oral Dispersible Tablets of Vibegron

In the present work, taste masking of Vibegron was carried out by using strong cation exchange resin tulsion 344. These taste-masked complexes were further formulated into the Oro dispersible tablet by the direct compression method using Ac-Di-Sol and Avicel as a super disintegrant. Vibegron is used in treating OAB symptoms. This thesis has described the production of a taste masked dosage form from initial determination of threshold bitterness concentration of the pure drug through to the development of a final taste masked prototype formulation.

An attempt has been made in the current work to use cation exchange resins (Indion 234 and Tulsion-344) which is used in the long drug therapy of AIDS and Vibegron used to treat overactive bladder, a common problem in geriatric patients. It was found that the taste masked 1:2 ratio of LMV: HP-β-CD inclusion complex increases the bulk of final ODT blend (above 1000 mg) which is not feasible for formulation of ODTs. So in this study the ODTs of LMV: HP-β-CD inclusion complex (1:1 ratio) showing acceptable bitterness in human taste panel studies was used in formulation of ODTs. In all formulations, the dispersion produced was soft (without grittiness) with a good mouth feel, and the bitter taste was fully masked.

In vitro drug release profile of all optimized ODT formulations showed around 90% of drugs release within 10 to 15 minutes in acidic buffer (pH 1.2), implying that the drug will be absorbed fast, increasing the chances of bioavailability. A three-month stability analysis was carried out. For the optimized formulations, there was no noticeable difference in time disintegration, hardness, friability, or drug content.

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Table 1: Formulation of ODTs of Vibegron:Tulsion 344 Complex

Following excipients are mentioned in the study besides other: Mannitol (Parteck-M), Microcrystalline cellulose (Avicel PH 101), Crosscarmellose Sodium (Ac-Di-Sol), Aerosil, HP-β-CD

G. Nagaraju1, V. Sirisha, Kavati Ramakrishna, Prof HAREESH Dara, Formulation and Evaluation Oral Dispersible Tablets of Vibegron, Article, January 2019, International Journal of Pharmacy and Biological Sciences-IJPBSTM (2019) 9 (2): 1524-1529, Online ISSN: 2230-7605, Print ISSN: 2321-3272, DOI: 10.21276/ijpbs.2019.9.2.184, https://www.researchgate.net/publication/386556261

Read also our introduction article on Disintegrants and Superdisintegrant Excipients here: