AAPS PharmSci 360: Challenges and Trends in Softgel Formulations

Pharmaceutical Technology® spoke with Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, during AAPS PharmSci 360 to discuss recent challenges and trends in softgel formulations.

“Recent challenges are mostly related to enhancing the solubility and making those solubilized molecules stabilized in the systems, particularly in softgels, and enhancing the bioavailability,” Sukuru said. He noted that there is an increasing demand for non-animal products by the industry, particularly in Europe where gelatin, an animal byproduct, is used as a shell component. Although gelatin is a good material to use in terms of its ability to make robust, subgenerative capsules, it also has some disadvantages, such as cross-linking challenges, Sukuru pointed out. “That is where [there is need] to address both the non-animal byproduct need, using plant-based materials, as well as … the cross linking issues,” he stated.

Sukuru’s talk at the conference, which is on Monday, Oct. 21, at 3:30 pm MT (2:30 pm PT, 5:30 pm ET), centers around the missed opportunity for superior bioavailability and the ability to develop moderated drug release products using softgels. “Softgel is one of the most versatile dosage forms, and you could deliver [a] drug through any orifice in the body, literally,” Sukuru said. “There are products that we manufacture commercially to deliver through oral route, ophthalmic route, nasal, otic, vaginal, and every route of delivery, but it's very underutilized. [Futhermore] there are a lot of myths and misconceptions about softgels being very expensive. No, they are not. In fact … compared to spray drying and some other bioavailability enhancing technologies, they are not.”

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Attendees can visit Catalent at Booth #1141 at AAPS PharmSci 360, which is taking place on Oct. 20–23 in Salt Lake City, Utah.

About the speaker

Karunakar (Karu) Sukuru, RPh, PhD, Global Vice-President-Rx Product Development, Pharma and Consumer Health, Catalent Pharma Solutions

Karunakar Sukuru (Karu) RPh, PhD is the global vice-president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions. With over 29 years of experience in the pharmaceutical industry, he has led the development and manufacturing of various drug delivery systems and technologies and has been responsible for product development and execution of projects globally. Sukuru had technical oversight of more than a dozen contract development and manufacturing organizations worldwide while working at Endo Pharma. In his current role at Catalent, he works with hundreds of pharmaceutical clients, including leading biopharma companies, globally. He has developed innovative controlled release platform technologies in softgel form (three granted patents) and has over 27 pending patent applications in the field of modified shell and fill suitable for capsules for enteric and colonic delivery and lyophilization. After completing his PhD in Pharmaceutics from IIT-BHU, India, in 1995, Sukuru began his career at Natco Pharma in India, where he developed a variety of oral dosage forms for two years. He then joined Banner Pharmacaps in India, and later in Banner Pharmacaps USA, he worked on softgel and gel enrobed tablets. Sukuru joined Endo Pharma in 2006 and Catalent in 2016 as the vice-president of Product Development. He is also a registered pharmacist.