Empty hard gelatin capsules

Sino-Ethiop Associate (Africa) PEC (SEAA) was established in March 2001 as a joint venture between an Ethiopian company, Zaf Pharmaceuticals PEC, and two Chinese companies (China Associate Croup and Dandong JINWAN Croup). SEAA produces empty hard gelatin capsules and sells them to pharmaceutical factories in Africa and the Middle East. Recently, SEAA completed its expansion project and doubled its production capacity, to 2.4 billion capsules annually. SEAA has recently acquired Certificate of PIC/S conformity. It will be shown later that companies established through joint venture have been generally successful. 

After tablets, hard gelatin capsules are the most common solid dosage form. Hard gelatin capsules are rigid two-piece capsules made from gelatin, water and colourants. The capsules are produced as empty shells consisting of a cap and body, which during the manufacture of the finished product are separated, filled with the formulation and then rejoined. 

Unlike hard gelatin capsule shells which are manufactured empty and subsequently filled in a separate operation, soft gelatin capsules are manufactured and filled in one operation. This is a specialised process and tends to be performed by a limited number of companies. One consequence, therefore, of selecting a soft gelatin capsule formulation is that the product will probably be manufactured by a contract manufacturer. A desire to keep all manufacturing in-house is one of the reasons for companies considering the use of liquid-filled hard gelatin capsules as an alternative. 

Figure 5. Brittleness test of capsules, a pressure resistance test, b hardness test. Capsules were filled with com starch in case of a and empty capsules were tested in case of b. n=30. Open symbols mean the data of HPMC capsules and closed symbols mean the data of gelatin capsules.

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