Formulation of oral solid-dose drugs in hard capsules offers many advantages, from the protection of potent or sensitive compounds to unique branding opportunities. However, these benefits can only be achieved by using high-quality empty capsules from reliable suppliers. Hard shell capsules offer unique advantages over other forms of solid oral dosage forms (SODFs). In addition to simplifying the development and manufacture of SODFs, they are also very flexible in dosage concentrations and delivery methods, and when sealed with tape, they increase barriers to counterfeiting and tampering

    For SODF formulated in hard-shell capsules, the quality and safety of the dosage form are directly related to the quality and safety of the hard capsules used to manufacture them. To ensure the successful production of SODF in hard-shell capsules, it is essential to work with a capsule manufacturer who can ensure the supply of empty capsules that consistently meet or exceed customer requirements.

    The raw materials used in capsule making include food additives, color additives, and ingredients generally recognized as safe. While there is significant overlap between regulations for the use of these ingredients in food supplements and pharmaceuticals in most countries (e.g. US, UK, EU, Japan, and Canada), there are some differences.

    Release testing of all empty capsule batches for sensory, physical, chemical, microbiological parameters, and AQL defects are performed in-house and in a qualified third-party laboratory to ensure that all capsules produced in our facility are of the quality level for which they were designed. In addition to providing the data for the certificate of analysis, the release test data also provides assurance for a smooth encapsulation process, allowing the production of defect-free filled capsules.

    Traceability of raw materials throughout the capsule manufacturing process is critical to ensuring the safety of hard-shell capsules used in SODF products.

    Xinchang County Hexin Capsules Co., Ltd. is an Empty Pharmaceutical Capsules Manufacturer from China, producing and selling Clear Vegetarian Capsules such as Empty HPMC Capsules.