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.
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.
The holder of a doctorate degree in pharmaceutical sciences from the University of Maryland, John Botzolakis has served in executive roles for pharmaceutical companies such as Soma Labs, Inc. and Kabco Pharmaceuticals. In his executive positions, John Botzolakis has written and supervised the implementation of numerous Standard Operating Procedures (SOPs).
SOPs are detailed guidelines on a company’s procedures regarding areas that are vital for quality, security, and safety. These procedures form the basis of how tasks will be conducted by employees and are written down as guiding policies.
SOPs in the food and nutrition industry are set up to guarantee the safety of food. They include procedures for cooking and heating food, packaging, and sanitizing work areas. Certain regulatory authorities such as the Food and Drug Administration (FDA) require SOPs to be part of compliance procedures for companies involved in that industry. In other industries, they are voluntary best-practice guidelines, such as the IFRS for financial companies.
SOPs offer workers confidence that their work is being supported by the management and that it is part of industry best-practice. The procedures also protect consumers by ensuring the final products are dependable and consistent with best-manufacturing processes.
John Botzolakis has over three decades of experience in the pharmaceutical and nutrition industries. The president and chief executive of Soma Labs, Inc, John Botzolakis has been invited as a public speaker in numerous pharmaceutical symposia.
Occasionally, career professionals are called upon to speak publicly on an issue, whether before their peers, boardroom executives, or in a conference. It is important to get the essentials of public speaking right for the message to be properly conveyed.
One imperative before making any public presentation is to plan well. Planning entails structuring the details of the presentation appropriately. It is about finding the right sequence of ideas and writing them down in an organized fashion. The ideas should flow seamlessly, back up the points with facts, and must be accompanied by a good introduction.
Have the audience’s expectations in mind when planning your introduction. You want to grab their attention from the start. You can do this by starting with an interesting statistic, a story, a fact relevant to your topic, or a catchy headline.
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.
An experienced pharmaceutical professional, Dr. John Botzolakis has conducted research that produced several patents. In 1988, while a research associate at Warner Lambert, Dr. John Botzolakis filed U.S. Patent No. 4,910,023 with two of his colleagues. The invention is a process for applying a coating to unpleasant tasting hygroscopic pills, making them easier for patients to use and protecting them from moisture.
Dr. Botzolakis’ patent is particularly helpful for the drug gemfibrozil. Gemfibrozil is prescribed to reduce lipids in the patient’s bloodstream and is classified as a fibrate. The medicine functions by reducing the liver’s triglyceride production, resulting in lower LDL levels and higher HDL levels as well.
Gemfibrozil is taken in pill form, and patients are typically instructed to take doses twice daily, 30 minutes before they eat in both the morning and evening. The drug should be taken in combination with a diet low in fat and cholesterol. Patients are often prescribed the drug under the brand name Lopid.
Natural Products Association
John Botzolakis is the founder, president, and CEO of Soma Labs, a company that makes vitamins and nutritional supplements. The mission upheld by John Botzolakis and Soma Labs is “to provide the highest quality products to the nutritional industry by taking a scientific approach in the development and manufacture of nutritional products.”
At Soma Labs’ production facility in Middlesex, New Jersey, the quality control process follows the Good Manufacturing Practices (GMPs) as outlined by the Natural Products Association (NPA). The NPA, which was formerly known as the National Nutritional Foods Association, is a nonprofit organization founded in 1936 to assist suppliers, retailers, and consumers of natural foods and supplements.
The purpose of the NPA’s Good Manufacturing Practices is to provide a set of guidelines to ensure that natural products are made according to the strictest quality measures. These practices are followed by many manufacturers across the entire natural products industry.
The NPA established GMPs specifically for dietary supplements in 1999, updating them in 2007 to reflect changes in FDA regulation. As before, the goal of the current GMPs is to set best practices and quality control measures in the industry, as well as to give consumers and retailers of natural products a universal set of standards to follow.