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Published in: Drugs & Therapy Perspectives 10/2017

Open Access 01-10-2017 | Original Research Article

Stability of medicines after repackaging into multicompartment compliance aids: eight criteria for detection of visual alteration

Authors: Valerie Albert, Michael Lanz, Georgios Imanidis, Kurt E. Hersberger, Isabelle Arnet

Published in: Drugs & Therapy Perspectives | Issue 10/2017

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Abstract

Introduction

Multicompartment compliance aids (MCA) are widely used by patients. They support the management of medication and reduce unintentional nonadherence. MCA are filled with medicines unpacked from their original packaging. Swiss pharmacists currently provide MCA for 1–2 weeks, although little and controversial information exists on the stability of repackaged medicines.

Objective

We aimed to validate the usefulness of a simple screening method capable of detecting visual stability problems with repackaged medicines.

Methods

We selected eight criteria for solid formulations from The International Pharmacopoeia: (1) rough surface, (2) chipping, (3) cracking, (4) capping, (5) mottling, (6) discoloration, (7) swelling, and (8) crushing. A selection of 24 critical medicines was repackaged in three different MCA (Pharmis®, SureMed™, and self-produced blister) and stored at room temperature for 4 weeks. Pharmis® was additionally stored at accelerated conditions. Appearance was scored weekly.

Results

Six alterations (rough surface, cracking, mottling, discoloration, swelling, and crushing) were observed at accelerated conditions. No alteration was observed at room temperature, except for the chipping of tablets that had been stuck to cold seal glue.

Conclusion

The eight criteria can detect alterations of the appearance of oral solid medicines repackaged in MCA. In the absence of specific guidelines, they can serve as a simple screening method in community pharmacies for identifying medicines unsuitable for repackaging.
Literature
3.
go back to reference Haywood A, Glass BD. Evidence of stability of medicines repackaged in compliance aids: a review. Curr Drug Saf. 2016;11(1):69–77.CrossRefPubMed Haywood A, Glass BD. Evidence of stability of medicines repackaged in compliance aids: a review. Curr Drug Saf. 2016;11(1):69–77.CrossRefPubMed
4.
go back to reference Gilmartin JF, Raimi-Abraham BT, Jani Y, et al. Taking the guesswork out of supplying multicompartment compliance aids: do pharmacists require further guidance on medication stability? Int J Pharm Pract. 2015;23(5):367–9. doi:10.1111/ijpp.12183.CrossRefPubMed Gilmartin JF, Raimi-Abraham BT, Jani Y, et al. Taking the guesswork out of supplying multicompartment compliance aids: do pharmacists require further guidance on medication stability? Int J Pharm Pract. 2015;23(5):367–9. doi:10.​1111/​ijpp.​12183.CrossRefPubMed
5.
go back to reference Haywood A, Mangan M, Glass B. Stability implications of repackaging paracetamol tablets into dose administration aids. J Pharm Pract Res. 2006;36(1):25–8.CrossRef Haywood A, Mangan M, Glass B. Stability implications of repackaging paracetamol tablets into dose administration aids. J Pharm Pract Res. 2006;36(1):25–8.CrossRef
7.
go back to reference USP-NF. United States Pharmacopeia and National Formulary (USP39-NF34), Second Supplement. The United States Pharmacopeial Convention Rockville, MD. 2016. p. Chapter 1136. USP-NF. United States Pharmacopeia and National Formulary (USP39-NF34), Second Supplement. The United States Pharmacopeial Convention Rockville, MD. 2016. p. Chapter 1136.
8.
go back to reference Guo Y. Impact of solid-state characteristics to the physical stability of drug substance and drug product. In: Ed Huynh-Ba K, editor. Handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices. New York: Springer Science + Business Media; 2009. p. 241–61.CrossRef Guo Y. Impact of solid-state characteristics to the physical stability of drug substance and drug product. In: Ed Huynh-Ba K, editor. Handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices. New York: Springer Science + Business Media; 2009. p. 241–61.CrossRef
18.
go back to reference Church C, Smith J. How stable are medicines moved from original packs into compliance aids? Pharm J. 2006;276(7384):75–81. Church C, Smith J. How stable are medicines moved from original packs into compliance aids? Pharm J. 2006;276(7384):75–81.
19.
go back to reference Snape TJ, Aastles AM, Davies J. Understanding the chemical basis of drug stability and degradation. Pharm J. 2010;285(7622):2. Snape TJ, Aastles AM, Davies J. Understanding the chemical basis of drug stability and degradation. Pharm J. 2010;285(7622):2.
21.
go back to reference Massey LK. Permeability properties of plastics and elastomers: a guide to packaging and barrier materials. 2nd ed. New York: Plastics Design Library/William Andrew Publishing; 2003. Massey LK. Permeability properties of plastics and elastomers: a guide to packaging and barrier materials. 2nd ed. New York: Plastics Design Library/William Andrew Publishing; 2003.
22.
go back to reference U.S. Food and Drug Administration. ICH guidance for industry Q1A (R2) stability testing of new drug substances and products. 2003. Accessed 18 Nov 2015. U.S. Food and Drug Administration. ICH guidance for industry Q1A (R2) stability testing of new drug substances and products. 2003. Accessed 18 Nov 2015.
Metadata
Title
Stability of medicines after repackaging into multicompartment compliance aids: eight criteria for detection of visual alteration
Authors
Valerie Albert
Michael Lanz
Georgios Imanidis
Kurt E. Hersberger
Isabelle Arnet
Publication date
01-10-2017
Publisher
Springer International Publishing
Published in
Drugs & Therapy Perspectives / Issue 10/2017
Print ISSN: 1172-0360
Electronic ISSN: 1179-1977
DOI
https://doi.org/10.1007/s40267-017-0431-9

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