STUDY OF THE REUSE OF CAPSULE CUTOUTS AND REPROVED CAPSULES AS RAW MATERIAL IN THE PRODUCTION PROCESS OF HARD GELATIN CAPSULES

Abstract

Inside of pharmaceutical industries there is a complex tangled of process and systems that always try to work the best way to improve their results, permitting the expansion of their activities and rise of their outputs. Empty hard gelatin capsules are marketed as a pharmaceutical ingredient to be filled with many kinds of medicines and have great relevancy to the product commercialized to the patient. Manufacturers of this pharmaceutical input are part of one of the bases of the world supply chain of products for drug manufacture and that’s why it is important that it´s procedures are capable of keep up their customer necessities. The objective of this paper is to develop and apply methodologies to reuse side products and therefore reduce costs with raw material and by using quality control and stability studies guarantee the safety of the developed methods. In this study were developed three specific methodologies to make the reuse of capsule cutouts, full colored and colorless capsules possible. Each methodology was tested in small and large scale, with all the products of this study being analyzed by quality control areas. The study has shown that it is possible to apply reuse methodologies on side products, avoiding the annual discard of tons of materials and consequently reducing fabrication costs. Concluding that it is possible to conciliate industrial process optimization and cost reduction with good manufacturing procedures.