Investigating the physical stability of repackaged medicines stored into commercially available multicompartment compliance aids (MCAs).

Bahijja Tolulope Raimi-Abraham,Alba Garcia Del Valle,Susan Anne Barker,Mine Orlu,Carlota Varon Galcera

doi:10.1111/jphs.12176

Abstract

BackgroundCompliance aids are devices which have been developed and are currently used to assist individuals in their medicines management. The use of compliance aids involves the transfer of medicines from the manufacturers' original packaging and repackaged into an multicompartment compliance aid (MCA). MCAs do not guarantee the same level of protection compared to manufacturer's original packaging.ObjectiveThe aim of this study was to investigate the stability profile of atenolol, aspirin and lansoprazole dosage forms repackaged together in two different commercially available MCAs.MethodsIn a laboratory in the United Kingdom, the physical stability of the formulations repackaged into two commercially available brands of MCAs was evaluated. After 8 weeks of storage (under controlled ambient conditions), changes in the disintegration (tablets only) and dissolution properties (all formulations) were examined in accordance with British Pharmacopoeia (BP) specifications.Key findingsFindings from this study confirm that changes in solid‐dosage form quality are observed when repackaged into MCAs compared to manufacturers packaging resulting in differences in in‐vitro dissolution performance. However, even with these changes, overall product performance was acceptable and within BP specifications.ConclusionThere is a need for greater collaboration in this area between manufacturers, hospital and community pharmacists, academics and policymakers to increase the data available on the physical stability and in turn performance of medicines repackaged into MCAs.

Highlights

Compliance aids, referred to as multicompartment compliance aids (MCAs) or dose administration aids (DAAs), are devices which have been developed and are currently used to assist individuals in their medicines management.[1]
There is a need for greater collaboration in this area between manufacturers, hospital and community pharmacists, academics and policymakers to increase the data available on the physical stability and in turn performance of medicines repackaged into MCAs
For MCA2, the equivalent values were 43, 63 and 63%. These results suggest that the dissolution profiles of atenolol FT change after repackaging into either MCA1 or MCA2 and subsequent storage for 8 weeks, whereas the dissolution profiles of both aspirin DT and lansoprazole GR-C are still comparable with the time 0 profiles

Summary

Introduction

Compliance aids, referred to as multicompartment compliance aids (MCAs) or dose administration aids (DAAs), are devices which have been developed and are currently used to assist individuals in their medicines management.[1] The rationale with most MCAs is that one compartment corresponds to a single administration time-point and all of the patient’s solid-dose medicines prescribed for that time-point are dispensed into that compartment.[2,3,4] Where the frequency of administration does not exceed four times a day, a 28-compartment MCA provides the patient with a 7-day dosing regimen for their solid-dose medication.[2,3] Participants at a public engagement event in 2013 entitled ‘How to improve medicines for older people?[5] felt that MCAs were widely available to improve patient outcomes in terms of medicine management, these aids may (in some cases) hinder compliance as oppose to improving it This could occur due to loss of contextual information on the appropriate use of their medicine when received in an MCA, often leading to an inability to identify which drug is used to treat their specific conditions. MCAs do not guarantee the same level of protection compared to manufacturer’s original packaging

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Conclusion