Extending Shelf Life Just Makes Sense

Diven, Dayna G.; Bartenstein, Diana W.; Carroll, Daniel R.

doi:10.1016/j.mayocp.2015.08.007

Cited by 21 publications

(11 citation statements)

References 6 publications

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“…The expiration date of Naproxen tablets, for instance, was extended for an average of 4.5 years. The expiration date of calcium chloride Injection-solution also was extended up to about 7 years [88].…”

Section: Discussionmentioning

confidence: 99%

Expired Medication: Societal, Regulatory and Ethical Aspects of a Wasted Opportunity

Alnahas

Yeboah

Fliedel

et al. 2020

IJERPH

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A massive volume of expired medications amasses annually around the world because of pharmaceutical overprescription, combined with overproduction. The accumulation of pharmaceutical waste imposes ecological, economic and social/ethical burdens. Managing this presumed “waste” has developed into a global challenge due to the absence of specific regulations, unreasonable behavior of the patients, and an improper understanding of the concept of “expired medications” in general. This paper summaries, first, the recent literature reporting practices related to the disposal of unused medications. In this context, 48 papers from 34 countries with a total of 33,832 participants point towards a significant lack of public awareness regarding the appropriate disposal of such biologically potent chemicals. These findings are corroborated by a local survey on the disposal practices of unused medicines among pharmacy students at Saarland University. The regulatory aspects surrounding this topic, often based on the official guidelines for the disposal of expired medications and local waste management strategies, are then discussed in light of these findings. Finally, a closer inspection of the epistemic values of expired medications and different strategies for managing expired medications have been reviewed.

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Section: Discussionmentioning

confidence: 99%

Expired Medication: Societal, Regulatory and Ethical Aspects of a Wasted Opportunity

Alnahas

Yeboah

Fliedel

et al. 2020

IJERPH

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“…A study conducted by the US FDA evaluated over 100 pharmaceutical dosage forms and showed that about 90% of them were safe and effective as long as 15 years past their expiration dates (5). Another other study had similar results, showing that many drugs stored under reasonable conditions retain 90% of their potency for at least 5 years after the expiration date on the label and sometimes much longer (3). Also, it is determined that four products, namely captopril tablets, flucloxacillin capsules, cefoxitin injection, and theophylline tablets, when stored under ambient temperatures maintained at least 98% of label claim for drug content for 18-170 months past the labeled expiration dates (6).…”

Section: Introductionmentioning

confidence: 64%

“…Expired pharmaceutical products have not necessarily lost potency, because the expiration date is only an assurance that the labeled potency will last at least until that time. Most pharmaceutical products continue to be effective and safe for a time after the expiration date (3)(4)(5)(6).…”

Section: Introductionmentioning

confidence: 99%

In Vitro Comparative Quality Evaluation of Non-Expired and 10 Years-Expired Lamotrigine Immediate-Release Tablet Formulations - Pilot Study

Parezanović¹,

Lalić-Popović²,

Goločorbin-Kon³

et al. 2020

Dissolution Technol.

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This study aimed to compare the different physical parameters and dissolution profiles of 10 years-expired with nonexpired lamotrigine (LTG) immediate-release tablet formulations. Dissolution tests were conducted using a validated high-performance liquid chromatography method. Dissolution characteristics of the tablet formulations were evaluated at three points spanning the physiological pH range (pH 1.2, pH 4.5, pH 6.8). Physical characteristics of LTG tablets were determined according to the European Pharmacopoeia. The dissolution profile comparison was carried out using model-independent (statistical) and model-dependent (kinetic) methods to provide detailed information about dissolution data. The t-test was applied to investigate differences between expired and non-expired tablets, and the differences were considered statistically significant if p ≤ 0.05. The results demonstrated no statistical differences in physical characteristics between expired and non-expired tablets; however, there were differences in the dissolution profiles, which could cause different pharmacokinetic profiles. The results of this investigation showed that the drug content did not change significantly. Therefore, the lower dissolution rate for expired LTG tablets is due to an interaction of LTG with one or more excipients in the tablet formulation during aging.

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“…However, only a few more studies investigating the long‐term stability of FFPs beyond their expiration dates can be found in the literature. Most of these studies conclude that actual shelf‐lives are often beyond the expiration dates …”

Section: Introductionmentioning

confidence: 99%

“…Most of these studies conclude that actual shelf-lives are often beyond the expiration dates. [12][13][14][15][16][17] In a previous study, nine parenterals manufactured in the last century were chromatographically investigated with regard to content and degradation products. 18 In spite of their high age of 53-72 years, five out of the nine ampoules were still within the content limits of 95%-105% such as metamizole (Novalgin ® ), furosemide (Lasix ® ), etilefrine (Effortil ® ), synephrine (Sympatol ® ), and caffeine and sodium salicylicum (Caffeinum Salicylicum).…”

Section: Introductionmentioning

confidence: 99%

A long‐time stability study of 50 drug substances representing common drug classes of pharmaceutical use

Zilker

Sörgel

Holzgrabe

2019

Drug Testing and Analysis

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For assurance of the quality of active pharmaceutical ingredients (APIs) used for manufacturing medicines, the analytical requirements of the European Pharmacopoeia serve as a guideline and have a binding character. Within a particular timeframe, an API is considered to comply with predefined specifications. If applicable, it can be used for the manufacturing of a finished pharmaceutical product. The objective of the study presented here was to assess the long‐term stability of 50 drug substances with an age of 20–30 years or even older in some cases. The substances are part of a collection of old pharmaceuticals at the Institute for Pharmacy in Würzburg, Germany, and represent commonly used drug classes containing β‐blockers, β‐sympathomimetic drugs, anticholinergics, anti‐infectives, non‐steroidal anti‐inflammatory drugs, antipsychotics, antihistaminic drugs, and one antiarrhythmic drug. The content and the degradation profile of the items were determined by means of potentiometric titration and liquid chromatography techniques based on pharmacopoeial approaches for impurity profiling covering all process and degradation related substances. The results of the study show that 44 out of 49 tested substances still complied with specifications of the current pharmacopoeias. For metipranolol, which is not monographed in any pharmacopoeia, a small degradation by hydrolysis was observed. In one lot of ampicillin sodium, atenolol, atropine, penbutolol, and salbutamol, at least one impurity did not meet the acceptance criteria, respectively. Some impurities were not related to degradation. However, a surprisingly high chemical stability of the old drug substances was revealed after more than two decades of storage.

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Extending Shelf Life Just Makes Sense

Cited by 21 publications

References 6 publications

Expired Medication: Societal, Regulatory and Ethical Aspects of a Wasted Opportunity

Expired Medication: Societal, Regulatory and Ethical Aspects of a Wasted Opportunity

In Vitro Comparative Quality Evaluation of Non-Expired and 10 Years-Expired Lamotrigine Immediate-Release Tablet Formulations - Pilot Study

A long‐time stability study of 50 drug substances representing common drug classes of pharmaceutical use

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