Dietary Supplements GMP Registration


Good Manufacturing Practices (GMPs) are guidelines that provide a system of processes, procedures and documentation to assure a product has the identity, strength, composition, quality and purity that appear on its label. These GMP requirements are listed in Section 8 of NSF/ANSI 173 which is the only American National Standard in the dietary supplement industry developed in accordance with the FDA’s 21 CFR part 111. NSF International independently registers manufacturers as meeting GMP requirements. The program is open not just to manufacturers of dietary supplements but also to manufacturers of ingredients and raw materials, as well as distribution, warehousing and packaging companies, who want to demonstrate their commitment to public safety.

Formulation and modifying drug release from Hard and Soft Gelatin Capsules for Oral drug delivery


Author: V. Deva Prasad Category: Life Sciences Abstract: Capsule is the most versatile of all dosage forms. Capsules are solid dosage forms in which one or more medicinal and inert ingredients are enclosed in a small shell or container usually made of gelatin. There are two types of capsules, “hard” and “soft”. The hard capsule is also called “two pieces” as it consists of two pieces in the form of small cylinders closed at one end, the shorter piece is called the “cap” which fits over the open end of the longer piece, called the “body”. The soft gelatin capsule is also called as “one piece”. Capsules are available in many sizes to provide dosing flexibility. Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell. The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most frequently utilized dosage. This proves the oral bioavailability of poorly soluble compounds, delivery of low and ultra-low doses of a compound using softgel also ensures decreased plasma variability. This has led to the commercial pharmaceutical and nutraceutical industries opting for the development of alternative shell forming materials instead of the traditional capsule shell material gelatin. This review discusses establishment and the ongoing development of the manufacturing technology for liquid and semisolid capsules with focus on progress and challenges of soft and hard gelatin capsules formulation in oral administration for improved solubility and as an absorption-enhancing technique. These considerations form a basis for new applications in oral drug delivery.   Keywords: Buccal drug delivery, folding endurance, index, in-vitro drug release, Permeation enhancers, swelling, Thiolated polymer DOI: 10.21276/IJRDPL DOI URL: Full Text:

The Benefits of Softgel Encapsulation


The debate over softgels versus tablets is a long-standing one that unfortunately won’t go away anytime soon. In light of this, we thought it would be useful to continue with our blog posts that explain the benefits of softgel encapsulation. As you likely know, we at Captek have been developing, testing, manufacturing, and customizing softgels for our customers since 1996. This longevity in the business has brought with it a clear understanding of how and why softgel capsules offer benefits and advantages to the front-line consumer and to supplement providers. Along with traditional gelatin softgels, we offer vegetarian/vegan capsules – both of these options include a long list of advantages over tablets: Flexible shapes make softgels easier to swallow. Sensitive ingredients are fully encapsulated and protected from tampering. Customers report reduced stomach discomfort when digesting softgels. Softgels are ideal for oils and fat-soluble formulations. Vegetarian and vegan encapsulation with the use of carrageenan ensures that people with dietary restrictions have greater freedom in their supplement, vitamin and mineral choices. Can be designed to be digested and broken down in a specific area of the gastrointestinal tract. Resistant to heat and temperature fluctuations, making them easy to transport and store. Consumers who have issues with the coating on tablets do not experience similar problems with softgel capsules.  In addition when you consider the ability to provide custom colors, shapes, sizes, and laser etching – softgels do come out ahead of tablets. Our team at Captek is capable of producing over 2.5 billion softgels annually in our 85,000 square foot facility that includes production, an analytical laboratory, a pilot laboratory and warehousing space. If you need assistance with soft gel product development, ingredient sourcing, analytical and stability testing or research and development support – our team can be counted on. This debate over soft gels versus tablets is one that won’t disappear overnight, but as you can read we are very confident that the softgel capsules and encapsulations offer a long list of advantages to all levels of consumers.

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