faqs
Simple answers to commonly asked questions.
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Qualicaps two-piece hard capsules are made from either animal-sourced gelatin, normally premium 100% bovine bone unless specified otherwise, or plant-sourced hypromellose.
There are two types of capsules: two-piece hard capsules that can be filled with a range of materials, from powders and pellets to liquids, and much thicker-walled “softgel” capsules made as a single-sealed unit together with a liquid or semi-solid fill. Capsules are easy to swallow because of their shape and are great for masking odors and tastes. Tablet formulations typically contain more excipients than capsules, including binders that aid in holding the tablet together. Many tablets are now offered in a capsule shape, called “caplets”, and are usually film-coated with various materials, including gelatin, to make them easier to swallow.
Capsules are water-soluble and are designed to start releasing their contents within minutes after swallowing, dissolving fully in the stomach. For more information about the in-vivo performance of the different Qualicaps® pharmaceutical capsule products, please refer to our Scientific Reviews, or contact us.
No; all Qualicaps® capsules are gluten-free and can be taken safely by individuals that show intolerance. Gluten is a protein found in wheat, rye, barley and oat products, none of which are used in the manufacture of two-piece hard capsules.
Hypromellose is the official Pharmacopeia name for hydroxypropyl methylcellulose (HPMC). It is a cellulose derivative made from plants and a principal raw material in capsules that presents an alternative to using materials of animal origin, like gelatin. Quali-V® capsules are made using hypromellose; in fact, they were the first patented ones made available to the pharmaceutical industry.
Yes; Qualicaps® band-sealing equipment can seal either Quali-V® or gelatin capsules. Quali-Seal Kits are available in both gelatin and hypromellose and can be colored to create differentiation and bolster product recognition.
Yes, we have documents for Kosher certification and can also provide Halal certification upon request. For further information on either of these certifications, please contact us and specify the Quality Assurance area.
Qualicaps® capsules that are maintained according to recommended storage conditions in protective sealed packaging have a shelf life of five years. Stability test results of properly kept capsules confirm that they maintain their moisture content properties and physical dimensions for the 5-year time period. For more information regarding warehousing and handling conditions, please refer to our Technical Manuals or contact us and specify the Quality Assurance area.
Capsule-based DPIs are simple to use and are breath-actuated, enabling efficient drug delivery to patients’ lungs. Patients can check that the correct dosage has been administered, as most capsules employed in DPIs are transparent and therefore allow the visual verification of powder emptying. Among other benefits, DPIs are also an environmentally-friendly device, as no solvents are used, unlike pressurized Multi-Dose Inhalers (MDIs).
Quali-V®-I are specifically designed for superior aerosolization properties, such as powder release and moisture content. With regard to the latter, Quali-V®-I capsules do not become brittle when exposed to low humidities, unlike gelatin capsules, and as a result, the puncture holes made by pins or blades in the device are more regular in size and shape, shedding less particles from the capsule shell. Their lower moisture content provides a more stable environment for labile APIs and contributes to their superior powder emptying characteristics.
Yes, Drug Master Files for the US and Canada have been registered for our pharmaceutical-grade capsule portfolio (Quali-G™, Quali-V®, Quali-V®-I). For additional details, please contact us and specify QC/QA & Regulatory.
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