Quality pharmaceutical capsule

A similar need exists in the quality control of pharmaceutical capsules and coated tablets, where their bulk content may be required. Although in many applications conventional Raman spectroscopy has proven to be very effective, in some cases the Raman signal or interfering fluorescence emanating from the capsule shell or tablet coating can severely reduce the sensitivity of conventional Raman spectroscopy. 

One disadvantage of soft gelatin capsules is that such products often must be contracted out to a limited number of firms having the necessary filling equipment and expertise. Materials must be shipped to the soft gelatin capsule facility, and products must be shipped back to the pharmaceutical manufacturer for final packaging and distribution. Additional quality control measures may be required. 

Eli Lilly founds a pharmaceutical company under his own name that pioneers a gelatin capsule to hold medicine and fruit flavoring for liquid medicine. The company later became successful in the discovery of new drugs and quality control in manufacturing. 

Two sets of standards are set for empty capsules, analytical and functional. Capsules, like all other pharmaceutical preparations, must comply with cGMP norms and must be made of materials that comply with pharmacopeial chemical and microbiological standards. However, these tests do not indicate whether a capsule will run well on a filling machine. Series of functional tests are applied by the manufacturers. The critical dimensions of a capsule (the lengths and diameters of the caps and bodies) are checked. It is a continuous production process, and there will be a very small proportion of visually defective capsules. Standard statistical sampling methods are used to estimate quality from samples. The manufacturers and users agree on acceptable quality levels (AQL). The faults are... 

Polymers are widely used in various pharmaceutical formulations, such as traditional oral formulations (tablets and capsule) and complex parenteral formulations (such as microspheres, nanoparticles, implants, and in situ forming gels). Dissolution testing is used in formulation development, quality control for batch release of product, and in vitro-in vivo correlations. FDA has a database listing dissolution methods for around 1000 formulations such as tablets, capsules, granules, and injectable suspensions. These methods provide information about the standardized USP apparatus used, testing speed, type and volume of release medium, and the recommended sampling points. For detailed informadon abont the seven standardized dissolution apparatuses, method development, and validation of compendial methods, the reader is referred to USP Chapters 711,... 

GACP, GMP and GLP standards. During the industrial manufacturing of herbal medicinal products not only the raw material is subject to rigid quality control, but also the quality of the semi-manufactured and finished product is monitored (in-process controls) and evaluated (end controls on content, identity, purity). Finally a pharmaceutical dosage form should comply with the applicable pharmacopoeial standards (e.g., crush strength of tablets, disintegration time of tablets and capsules, uniformity of mass and content [11-13]). 

Two preparations of Cordyceps, called Jinshuibao and Jinshukang are produced by Jiangxi Pharmaceutical Co. Ltd. The Jinshuibao capsule Cordyceps have equal effects as the Cordyceps sinensis drug. It is used for the treatment of chronic bronchitis, sexual dysfunction, hyperlipemia, menstrual disorder, pains in the loins and abdomen, leucorrhea, senile weakness, cardiovascular diseases, liver cirrhosis, and in supplementary tumor treatment. In 56 cases with cancer, Jinshuikang capsule significantly improved the immune functions and raised the quality of life of the patients [35]. As shown in Table 8, the immune and humoral cell functions are markedly increased after treatment [36]. 

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