Gummi Formulations Comprising Amenamevir Solid Dispersions with Polyvinyl Alcohol

Abstract

The aim of the present study was to determine whether solid dispersions (SDs) are applicable to gummi formulations. Amenamevir was selected as a model of a poorly water-soluble drug, and polyvinyl alcohols (PVAs) with various degrees of hydrolysis (PVA 66, PVA 80, PVA 88, and PVA 66/88) were used as SD carriers. Design of experiments (DOE) was used to develop a gummi formulation that was suitable for an amenamevir SD using SD with PVA 66. Dissolution studies and clinical sensory tests on 11 formulations calculated by DOE revealed that a gummi formulation comprising 10.5% gelatin and 22.8% water was suitable for SD of the drug. Gummi formulations comprising amenamevir SDs with various PVAs were prepared using the determined gummi formulation, and their ability to dissolve amenamevir, their stability, and their oral absorption in dogs were evaluated. The results suggested that PVA 66, PVA 66/88, and PVA 80 were appropriate in terms of dissolution, stability, and in vivo absorption, respectively. Considering these results comprehensively, it was concluded that PVA 80, which enabled the highest degree of absorption, was the most suitable SD carrier for gummi formulations. Thus, it was possible to apply a PVA SD of amenamevir to gummi formulations.

Oral Drug Delivery Systems Applied to Launched Products: Value for the Patients and Industrial Considerations

“…HPMC maintained the supersaturation of the widest range of drugs, , whereas other polymers were more effective for many other drugs . It is difficult to predict which polymer shows the best dissolution and supersaturation for a target drug without experimental screening. , Academia and industry have intensively researched a range of hydrophilic polymers for SDs, such as copolyvidone, PVP, poly­(vinyl alcohol), , and aminoalkyl methacrylate (AAM) copolymer E. , The dissolution, supersaturation, and storage stability are also affected by differences in molecular weight, degree of substitution, and amount of impurities in lots and batches of the polymers.…”

Improved Palatability of Gummy Drugs of Epinastine Hydrochloride Using Organoleptic Taste-Masking Methods

“…We have previously prepared gummy drugs containing bitter-tasting acetaminophen, aripiprazole, and amenamevir. [6][7][8][9] Because the unpleasant taste and poor palatability of drugs generally result in poor adherence, it is important to develop pharmaceutical formulations to overcome these issues. Tastemasking methods including physical, chemical, and organoleptic masking methods are used to mask the unpleasant tastes of drugs, and they play an important role in dosage formulations.…”