YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
ISSN-L : 0031-6903

This article has now been updated. Please use the final version.

Comparison of the Pharmaceutical Characteristics of Brand-name and Generic Pramipexole Extended-release Tablets and their PTP Package Usability
Shigeo AkiyamaChieko MaidaEtsuko MiyamotoNobuyuki Doi
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JOURNAL FREE ACCESS Advance online publication

Article ID: 19-00029

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Abstract

The pramipexole extended-release (long acting) tablet, a D2 receptor agonist commonly used for the treatment of Parkinson's disease, has increasingly demonstrated usability for patients with long acting performance and patient adherence improvements. As a generic drug it is sold by six companies while a brand name drug is also marketed. As these formulations are hygroscopic it is described as such in package inserts so that tablets will only be removed from the PTP (Press-Through Package) immediately before ingestion. It is often dispensed in ODP (One-Dose Packaging) as determined by a patient's physical functions and symptom characteristics. With ODP, quality control and ease of removal from the PTP are important factors. In this study we examined the stability of tablets in the ODP (25℃ RH75%) while also comparing the ease of handling of the seven products currently marketed in Japan. In the tablets’ ODP, changes such as swelling and decreases in tablets hardness were observed in six formulations. Differences were found among the products in comparison of packaging material, required tablet extrusion strength, and ease of removal. Given the differences in PTP materials and hygroscopicity it is suggested that pharmacists must not only consider the drug formulations of products but also contribute to improvements in medication adherence for patients with poor hand-finger function.

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© 2019 The Pharmaceutical Society of Japan
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