U.S. Patent No. 4,910,023 Helps With All Orally-Ingested Drugs

Dr. John E. Botzolakis has extensive experience in the pharmaceutical and nutritional industries. For over 30 years, he has contributed greatly to the industry with three patents and multiple publications, mainly focused in the areas of solid dosage development and instrumentation for process control. His latest patent, U.S. Patent No. 4,910,023, “Drug in Combination with Flavor Masking Agent and Method for Making Same,” is an improvement on the suitability of orally-ingested drugs.

All drugs must be delivered at a correct dosage and often require time-released agents to protect the drug from rapid moisture absorption of the body. Hydroscopic drugs (i.e. drugs that have the ability to attract and hold water molecules from their environment) often have an unpleasant taste and their waxy coating often presents problems during the encapsulation process. Dr. Botzolakis’ patent is essentially a silicon dioxide coating that masks the unpleasant taste of these drugs. The coating also assists in the timely release of the drug by decreasing moisture absorption, which makes the pill become easier to swallow and digest.

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Soma Labs’ Quality Control Program

Soma Labs pic

Soma Labs
Image: somalabs.com

The recipient of a PhD in pharmaceutical sciences from the University of Maryland, John Botzolakis has gained recognition in the pharmaceutical industry by publishing various articles and securing three patents. Drawing on this background, John Botzolakis serves as president and CEO of Soma Labs, a New Jersey company he founded in 1998.

As a contract manufacturer of nutritional supplements and vitamins, Soma Labs has established a comprehensive Quality Control Program with in-process controls based on guidelines set forth by the Food and Drug Administration. Soma Labs also executes and documents every operational process in adherence with the Good Manufacturing Practices established by the National Nutritional Foods Association.

With carefully defined standard operating procedures in place, Soma Labs is able to create uniform and reproducible products and results. The company starts with the highest quality raw materials from reputable suppliers and performs quality control testing to confirm product purity, quality, and strength. When a product is completed, Soma Labs submits it for independent testing as a final quality control measure.

What Are Probiotics?

Soma Labs pic

Soma Labs
Image: somalabs.com

In 1999, Dr. John Botzolakis founded Soma Labs, a contract manufacturer of nutritional supplements and vitamins. At Soma Labs, Dr. John Botzolakis makes products of all kinds, from daily vitamins to special products for pets. One such product is probiotic supplements.

Probiotics have grown enormously in popularity in recent years. The term probiotic means “for life,” and probiotic supplements are taken in the belief that they promote intestinal health. Probiotics themselves are living bacteria and other microorganisms that live in the body and assist with digestion. While probiotics can be found naturally in such fermented foods as yogurt and sauerkraut, probiotics in pill and powder form are becoming increasingly available.

Like other natural remedies, probiotics are regulated by the FDA as a food and not a drug, which means that they are generally safe for consumption but that their health claims are not verified. The National Center for Complementary and Integrative Health is conducting research on probiotics, and the public will know more about their benefits in years to come. To learn more about Dr. Botzolakis’ company, Soma Labs, visit its website at www.somalabs.com.

Soma Labs’ Encapsulation Service

John Botzolakis has dedicated more than three decades to the pharmaceutical and nutritional industries, and in that time he has obtained three patents. John Botzolakis also founded Soma Labs in Middlesex, New Jersey, leading the company as president and CEO.

Soma Labs manufactures vitamins, supplements, probiotics, and other specialty products that help consumers maintain healthy lives. In addition, the company offers a variety of contract services, such as tableting and encapsulation.

From immediate to controlled release and enteric coated tablets and capsules, Soma Labs is equipped to develop tablets and capsules in various sizes. To create the nutritional products, Soma Labs uses various types of tablet press and capsule filling machines, producing up to 100,000 units per hour. Change parts of varying sizes allow the company to customize each type of tablet and capsule.

To learn more about the Soma Labs’ services, visit http://www.somalabs.com.

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.

The 2015 AAPS Annual Meeting and Exposition

With expertise in pharmaceutical product development and business leadership, John Botzolakis serves as the founder, president, and CEO of a contract vitamin and supplement manufacturing company called Soma Labs in New Jersey. John Botzolakis’ work has also resulted in three patents, numerous publications, and various presentations at leading pharmaceutical seminars, including the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting.

In October, the AAPS will host its 2015 Annual Meeting and Exposition at the Orange County Convention Center in Orlando, Florida. Attendees will enjoy seminars on important industry topics, presentations by leading scientists, and networking with professionals from around the world. During the conference, participants will explore seven program themes, such as big data and drug delivery technologies. The keynote speaker at the 2015 AAPS Annual Meeting will be Jack Andraka, the inventor of a cost-effective early-detection test for different types of cancer.

According to the AAPS, the Annual Meeting provides scientists with the most recent developments in the field to help advance research efforts and inform research teams. The five-day conference also provides access to the resources needed to progress concepts to the next stage of development.