Soft capsule formulation technology presents an advantage to certain drug substances by overcoming its solubility and physical constraints that may inhibit use of alternate dosage forms. The technology can provide a product differentiation advantage. The relatively established quality-by-design (QbD)-based formulation and process development approaches for soft capsules can result in a lower development cost, potentially reducing time-to-market. The soft capsule formulation technology is an ideal candidate for 505(b)(2) submission pathway, and at the same time best for emerging small-molecule pipelines. The availability of dedicated soft-capsule development and commercialization sites catering to a wide range of batch sizes fitting a spectrum of fill formulation types makes the technology highly accessible. The dosage form can be used to improve bioavailability of Class II and IV drug substances and improve product stability. Emergence of vegetarian capsule shell formulations annuls the dietary concerns stemming from use of animal-based gels. New developments in soft capsule technology allows for considering the dosage delivery system as one of the preferred solid oral formulations that can achieve a high rate of patient compliance.

Peer-reviewed research

Submitted: Aug. 3, 2022
Accepted: Sept. 2, 2022

About the authors

Sam Turner is director of Technology and Development; Naresh Talwar, PhD, is director of Product Development; and Ajay Pazhayattil^*, M.Pharm, DBA, [email protected], is vice-president, Scientific and Regulatory Affairs; all at Capcium.

^*To whom all correspondence should be addressed.

Article details

Pharmaceutical Technology
Volume 46, Number 11
November 2022
Pages: 32–35

Citation

When referring to this article, please cite it as S. Turner, N. Talwar, and A. Pazhayattil, “Novel Formulations and Line Extensions with Soft Capsule Technology,” Pharmaceutical Technology 46 (11) 32–35 (2022).