Related Experiment Video
Updated: Jun 8, 2026
11:27
A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Package selection for moisture protection for solid, oral drug products.
Kenneth C Waterman1, Bruce C MacDonald
1Pfizer Global Research and Development, Eastern Point Road, Groton, Connecticut 06340, USA. ken.waterman@pfizer.com
Journal of Pharmaceutical Sciences
|September 17, 2010
Summary
Selecting appropriate packaging for solid oral drugs involves assessing moisture protection for chemical and physical stability. This method predicts drug stability over time by calculating internal relative humidity and using stability assessment programs.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- Solid oral drug products require careful packaging to maintain chemical and physical stability.
- Moisture ingress is a primary concern affecting drug product shelf-life and efficacy.
- Existing methods for packaging selection often lack a quantitative approach to moisture management.
Purpose of the Study:
- To present a systematic approach for selecting optimal packaging for solid oral drug products.
- To integrate chemical and physical stability considerations with moisture protection.
- To provide a scientifically-based method for packaging selection and evaluation.
Main Methods:
- Quantifying initial moisture content of dosage form components.
- Calculating moisture transfer using moisture vapor transfer rate (MVTR).
- Estimating internal relative humidity (RH) using moisture sorption isotherms and desiccants.
- Predicting chemical stability via an Arrhenius equation and Accelerated Stability Assessment Program (ASAP).
- Defining physical stability thresholds based on critical RH levels.
Main Results:
- A comprehensive methodology for predicting drug product stability within various packaging configurations.
- Integration of moisture dynamics, desiccant performance, and drug degradation kinetics.
- A framework for assessing the impact of storage conditions and packaging changes on stability.
- Recommendations for maintaining physical dosage form integrity based on RH thresholds.
Conclusions:
- The described process enables scientifically-driven packaging selection for solid oral drug products.
- This approach allows for explicit accounting of the effects of storage conditions and packaging modifications.
- It provides a robust tool for ensuring long-term drug product quality and safety.
Related Concept Videos
01:23Oral Drug Delivery Systems: Introduction
Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
01:27Drug Delivery Systems: Different Types
Conventional oral drug products, termed immediate-release (IR) formulations, are engineered to promptly release their active pharmaceutical ingredient (API) upon ingestion, typically in tablets or capsules. This rapid release often results in swift drug absorption and consequent pharmacodynamic effects, although the timing and intensity can vary depending on the drug's properties. Prodrugs within these formulations require metabolic conversion to activate their pharmacodynamic effects,...
01:11Oral Drug Delivery Systems: Delayed-Release Systems
Delayed-release drug delivery systems are specialized pharmaceutical formulations designed to postpone the release of active compounds until the drug reaches a specific region of the gastrointestinal (GI) tract, typically the intestine. These systems are essential for drugs that may cause gastric irritation, are unstable in acidic environments, or need to exert therapeutic effects locally in the intestinal or colonic regions.The core feature of delayed-release systems is the use of enteric...
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
01:26Oral Drug Delivery Systems: Continuous-Release Systems
Continuous-release drug delivery systems offer a strategic approach to maintaining therapeutic drug levels over extended periods following oral administration. By modulating the release rate of active pharmaceutical ingredients, these systems minimize fluctuations in plasma concentrations, which enhances clinical efficacy and reduces the need for frequent dosing. Such characteristics make them particularly advantageous in managing chronic diseases where patient adherence and stable drug...