Disintegration of Hard Gelatin Capsules

Based in New Jersey, Dr. John Botzolakis has built a career as a nutritional and pharmaceutical professional over the course of more than three decades. At the same time he has served as the CEO and president of Soma Labs, Inc., Dr. John Botzolakis has written articles for publication in professional journals on various topics including the use and efficacy of disintegrating agents used in hard gelatin capsules

The pharmaceutical industry offers two kinds of gel capsules in either one-piece or two-piece forms. While soft gelatin capsules normally contain oil-based medication, hard gelatin capsules hold pharmaceuticals in the form of powder. Hard capsules contain a number of ingredients that aid in dilution and lubrication. Immediate-release capsules also commonly include a mixture of several different disintegrants, including croscarmellose sodium, sodium starch glycolate, crospovidone, alginic acid, and corn starch. These elements help capsule manufacturers control the disintegration process and dissolution of the active substances.

High solubility plays a key role in disintegration times for hard gelatin capsules. If the capsules contain disintegrants or are highly water soluble, water will quickly break down the outer layer and release the contents. Ideally hard gel capsules should disintegrate within 10 minutes of ingestion.

Invention Addresses Medication Taste, Odor, and Manufacturing Issues

John Botzolakis leverages more than 30 years of experience in the nutrition and pharmaceutical industries to serve as the founder, president, and CEO of Soma Labs, a contract vitamin and supplement manufacturer based in New Jersey. As an independent researcher, John Botzolakis is also listed as the primary inventor on three patents, including one titled Drug in Combination with Flavor Masking Agent and Method for Making Same.

The patent documents provide background on the invention, explaining that the majority of drugs are intended for oral ingestion, so the drugs must be modified for delivery based on dosage requirements and occasionally protected from fast moisture absorption. However, some hygroscopic drugs contain unpleasant odors and tastes, which can lead to patient compliance violations as people are less willing to consume the appropriate dosage. Manufacturers also have trouble with hygroscopic and waxy drugs because they are difficult to process during encapsulation and tableting.

To address these issues, the inventors developed a wet granulation process that leads to a protective silicon dioxide coating that covers unpleasant odor and taste, while also improving the granule manufacturing process.