Related Experiment Video
Updated: May 2, 2026
10:43
Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
Published on: June 27, 2014
19.6K
Comparing suppository mold variability which can lead to dosage errors for suppositories prepared with the same or
Kenneth S Alexander1, Gabriella Baki2, Christine Hart2
1University of Toledo, College of Pharmacy and Pharmaceutical Sciences, Toledo, OH 43614, USA. kenneth.alexander@utoledo.edu
International Journal of Pharmaceutical Compounding
|March 4, 2014
Summary
Accurate dosing requires calibrated suppository molds. This study presents a straightforward method for calibrating standard aluminum suppository molds, ensuring precise medication delivery.
Area of Science:
- Pharmaceutical Technology
- Compounding Pharmacy
- Drug Delivery Systems
Background:
- Accurate dosing is critical in pharmaceutical compounding.
- Suppository molds exhibit variations affecting final product weight and dosage.
- Standardization of suppository mold calibration is essential for reproducible results.
Purpose of the Study:
- To present a method for calibrating standard aluminum suppository molds (6-, 12-, 50-, and 100-well).
- To ensure accurate and reproducible dosing in suppository preparations.
Main Methods:
- Calibration of suppository molds using water to determine volume.
- Standardization using cocoa butter to establish the density factor.
- Testing of ten different standard aluminum suppository molds.
Main Results:
- The described method is straightforward to implement.
- The calibration technique effectively accounts for variations between mold cavities.
- The method provides a reliable way to standardize suppository molds.
Conclusions:
- The presented method is appropriate for the calibration of standard aluminum suppository molds.
- Proper mold calibration is crucial for achieving accurate suppository dosing.
- This technique supports consistent and reliable pharmaceutical compounding practices.
Related Concept Videos
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
226
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,...
226
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
420
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
420
01:24Dosage Regimen: Individualization
398
Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
398
01:19Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
241
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
241
01:14Drug Dissolution: Requirements and Profile Comparison
500
The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
500
01:22Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
259
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
259