The Need for LBFs and Challenges in Oral Biologic Formulation (AAPS PharmSci 360)

Editor's note: this interview was originally published on PharmTech.com.

The Pharmaceutical Technology Group spoke with Karunakar Sukuru, RPh, PhD, global vice president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, at AAPS PharmSci 360 about the advantages and new challenges with lipid-based formulations (LBFs). Sukuru also discussed the challenges of addressing bioavailability in the search for developing oral formulations for biologics.

“Lipid-based drug delivery systems are not new,” Sukuru said, noting, though, that although lipid-based drug delivery systems exist, there is, today, an increased need for them, particularly considering that of the almost 8500 or so molecules—small molecular entities—in development, 70% of them are poorly bioavailable. “Because [these small molecules] are either poorly soluble, or poorly soluble and poorly absorbed, [that] is where the lipid-based formulation comes into play … they have a very demonstrated and valuable utility,” he stated. LBFs enhance bioavailability, so that a molecule may not necessarily need to have aqueous solubility.

Meanwhile, delivering biologics or proteins through an oral route is very challenging because of their high molecular weight. “[There] [are] certain limitations; the body does not allow absorb[tion of] these high molecular weights … with most monoclonal antibodies or biologics, they are in the hundreds of 1000s of Daltons [in size],” Sukuru pointed out. “However, there are a lot of efforts going on, and novel formation and answers are showing good promise, where they open the tight junctions, facilitating the absorption of the molecules,” he added. Another challenge he emphasized is stabilizing the biologic molecule once it is delivered to the intestine, where it would otherwise be destroyed by an acidic environment.

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Attendees can visit Catalent at Booth #1141 at AAPS PharmSci 360, which is taking place on Oct. 20–23, 2024 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.