The Purpose and Types of US Patents

As founder of Soma Labs, Inc., John Botzolakis, PhD, has established a successful career of some three decades in the pharmaceutical and nutrition industries. Dr. John Botzolakis is the holder of three patents related to pharmaceutical production.

A patent, issued by the United States Patent and Trademark Office (USPTO), grants property rights to an inventor for 20 years from the time an application is filed. Issuance of a patent restricts others from making, using, offering for sale, or importing the invention.

The USPTO offers three types of patents. A utility patent protects the invention of new processes and machines as well as articles of manufacture. The composition of matter and new and useful improvements qualify for that kind of patent. A design patent, which has a shorter term than that or an invention, grants property right of original and ornamental design of an item to be manufactured. Finally, a plant paten protects the invention or asexual reproduction of a distinct plant variety.

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FDA Stipulations on Dietary Products

The owner of three patents related to the field of pharmaceuticals and nutrition, John Botzolakis, PhD, leads Soma Labs, Inc., as president and chief executive officer. John Botzolakis has dedicated 17 years to the vitamins-and-supplements company, during which he implemented a quality control program that meets Food and Drug Administration (FDA) regulations.

To protect the well-being of consumers, the FDA requires companies manufacturing and distributing dietary products, such as vitamins and minerals, to adhere to the following stipulations.

Label supplements accurately. Companies must ensure the quality and purity of a product as outlined in FDA’s Current Good Manufacturing Practice (CGMP). Labels must truthfully represent the product. Supplemental literature, including package inserts, may be used to provide other vital information.

Submit adverse event reports. Whether it is the manufacturer, packer, or distributor, the company that appears on the label is required to notify the FDA any time an adverse event occurs.

Notify use of new dietary ingredients. A manufacturer or distributor may only market a supplement containing a new dietary ingredient if there is reasonable evidence indicating safer consumption with the additional element, according to the Federal Food, Drug, and Cosmetic Act. As such, inclusion of new ingredients must be approved by the FDA.

The Purpose of Enteric Coating

New Jersey resident John Botzolakis holds a master’s degree in pharmaceutical sciences and a doctor of philosophy in industrial-physical pharmacy from the University of Maryland, Baltimore. John Botzolakis leverages his education and more than 30 years of experience in the pharmaceutical and nutrition sectors to lead Soma Labs, a developer and manufacturer of nutritional products.

One of the products available through Soma Labs is enteric coated tablets and capsules, which are oral medications or supplements coated with a polymer that minimizes dissolution as the tablet travels through the body to the small intestine. Without enteric coating, the product can prematurely dissolve in the stomach, causing irritation, instability of the active components and/or lower absorption.

Because enteric coating is made to withstand acidic environments and break down only in non-acidic, or alkaline conditions, a tablet or capsule should always be taken whole to maintain efficacy. Crushing the product is not recommended, as it can reduce the strength of a product. Enteric coating is often used in aspirin as well as arthritis medications. In addition, it is used in certain nutritional supplements, such as fish oil, to ease consumption and eliminate aftertaste.

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.

Entrepreneurship at the University of Maryland School of Pharmacy

Dr. John Botzolakis presently serves as the president and chief executive officer of Soma Labs, Inc. Dr. John Botzolakis received his MS in pharmaceutical sciences and his PhD in industrial-physical pharmacy from the University of Maryland. Among the oldest pharmacy programs in the United States, the University of Maryland (UM) School of Pharmacy sponsors a number of research and discovery initiatives, including the entrepreneurship program.

A core component of the UM School of Pharmacy’s strategic plan, the entrepreneurship program gives students and faculty the opportunity to use their knowledge in practical applications. Over the years, faculty members have drawn upon their scholarly work to develop new technologies, patents, and startup companies, often with the help of students. The UM School of Pharmacy collaborates with a number of statewide initiatives, including the Maryland Department of Business and Economic Development and the Maryland Technology Development Corporation.

To learn more about entrepreneurship at the UM School of Pharmacy, visit http://www.pharmacy.umaryland.edu.