Improved Protocol and Data Analysis for Accelerated Shelf-Life Estimation of Solid Dosage Forms

Waterman, Kenneth C.; Carella, Anthony J.; Gumkowski, Michael J.; Lukulay, Patrick; MacDonald, Bruce C.; Roy, Michael C.; Shamblin, Sheri L.

doi:10.1007/s11095-006-9201-4

Cited by 107 publications

(73 citation statements)

References 10 publications

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“…The use of accelerated stability studies is a wellestablished technique that has been widely used for more than 60 years to predict the shelf life and storage conditions of drugs and drug products (Baertschi 2007;Huynh-Ba 2008;Karstensen 1990;Waterman & Carella 2007). Whereas the experimental approaches may vary between studies, the general principles are the same and are based on the extrapolation of the rate of degradation at two or more temperatures above the intended condition, using the Arrhenius Relationship (Eq.…”

Section: Introductionmentioning

confidence: 99%

Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)

Nadig

Kuzmission

et al. 2016

AAPS Open

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The computer program ASAPprime® has been used successfully for some time to predict the stability of active pharmaceutical ingredients (APIs) in solid-dosage forms. In this study, we have demonstrated that the ASAPprime® program can also be used to predict the slow-down in dissolution of two APIs in an immediate release tablet. The tablets were pre-equilibrated at 25°C at different relative humidities (30-75 %), sealed in aluminum pouches and stored at temperatures ranging from 50-60°C for 3, 7 or 14 days. The storage times were selected to encompass the time needed to produce a slowdown in dissolution such that the amount of the two APIs fell below the acceptance criteria of no less than 80 % dissolved in 20 min. Up to 6 months of stability data from a 40°C/75%RH open dish study were also included in the modeling. The effects of temperature (T in°K) and relative humidity (RH) were then shown to be related to the isoconversion (IC) time by an empirical, modified Arrhenius equations, where IC is the time for the amount dissolved to equal 80 % of the label claim. These studies showed that while the slowdown in dissolution of API 2 was influenced more by the relative humidity than API 1, the overall slowdown in dissolution was more sensitive to changes in temperature than changes in relative humidity. In addition to showing that ASAPprime® could be used to model the effects of temperature and relative humidity on dissolution, the software was also used to demonstrate that no special precautions were necessary to protect the tablets from moisture and they could be stored in Aclar blisters®. It was also shown that the water content of the tablet was not a critical quality attribute and need not be included in the drug product specification.

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Section: Introductionmentioning

confidence: 99%

Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)

Nadig

Kuzmission

et al. 2016

AAPS Open

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“…However, when physical changes occur, the reaction rates typically do not follow Arrhenius model, then a model can be designed to predict stability profile throughout the expiration dating period. With such model, predictive stability studies can support the selection of packages and/or formulations, to justify excursions and provide insight on in-use stability (Genton & Kesselring 1977;Waterman et al 2007). In addition, these data could also be used to justify the retest period for clinical trial material and to justify lean post-approval protocols.…”

Section: Topic C: Challenges and Best Practices For Successful Predicmentioning

confidence: 99%

Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD

Huynh‐Ba¹,

Larner²,

Strickland³

et al. 2017

AAPS Open

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“…From the ASAP stability data, one Maillard degradation product was identified as being most likely to breach the impurity specification limits of 0.3% w/w within 2 years. The data relating to this impurity were separated out from that for the summed monosaccharides and fed into a humidity corrected Arrhenius equation (32) in order to calculate in use periods for the three capsule blends using the API engineered from various particle engineering technologies. Table V shows the predicted shelf life of the capsule blends incorporating the three types of API particles.…”

Section: Drug Product (Formulation) Stabilitymentioning

confidence: 99%

Towards Integrated Drug Substance and Drug Product Design for an Active Pharmaceutical Ingredient Using Particle Engineering

2011

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Abstract. A novel experimental approach describing the integration of drug substance and drug production design using particle engineering techniques such as sonocrystallization, high shear wet milling (HSWM) and dry impact (hammer) milling were used to manufacture samples of an active pharmaceutical ingredient (API) with diverse particle size and size distributions. The API instability was addressed using particle engineering and through judicious selection of excipients to reduce degradation reactions. API produced using a conventional batch cooling crystallization process resulted in content uniformity issues. Hammer milling increased fine particle formation resulting in reduced content uniformity and increased degradation compared to sonocrystallized and HSWM API in the formulation. To ensure at least a 2-year shelf life based on predictions using an Accelerated Stability Assessment Program, this API should have a D [v, 0.1] of 55 μm and a D [v, 0.5] of 140 μm. The particle size of the chief excipient in the drug product formulation needed to be close to that of the API to avoid content uniformity and stability issues but large enough to reduce lactam formation. The novel methodology described here has potential for application to other APIs.

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Improved Protocol and Data Analysis for Accelerated Shelf-Life Estimation of Solid Dosage Forms

Abstract: The new protocols and analyses provide accurate and precise shelf-life estimations in a reduced time from current state of the art.

Cited by 107 publications

References 10 publications

Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)

Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)

Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD

Towards Integrated Drug Substance and Drug Product Design for an Active Pharmaceutical Ingredient Using Particle Engineering

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