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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors 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...
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

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...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical 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,...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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...
Oral Drug Delivery Systems: Introduction01:23

Oral 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.
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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...

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Quality-control analytical methods: considerations in compounding peroral solid dosage forms.

Nicole Vu1

  • 1Analytical Research Laboratories, Inc., Oklahoma City, Oklahoma.

International Journal of Pharmaceutical Compounding
|August 27, 2013
PubMed
Summary
This summary is machine-generated.

Compounding pharmacists must ensure drug dosage uniformity in capsules and tablets using United States Pharmacopeia (USP) Chapter 905 methods. Accurate weighing and blending are crucial for consistent and safe pharmaceutical preparations.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Formulation
  • Quality Control

Background:

  • Pharmacists compounding medications must adhere to United States Pharmacopeia-National Formulary guidelines.
  • Capsules and tablets are preferred dosage forms due to their stability and convenience for drug combinations.

Purpose of the Study:

  • To outline the standards for ensuring dosage unit uniformity in compounded peroral solid formulations.
  • To highlight the importance of specific United States Pharmacopeia (USP) chapters in pharmaceutical compounding.

Main Methods:

  • Discussion of United States Pharmacopeia Chapter 905 standards for uniformity of dosage units.
  • Explanation of the two primary methods for demonstrating uniformity: Content Uniformity and Weight Variation.

Main Results:

  • Dosage units in compounded formulations must demonstrate consistency and uniformity.
  • Accurate weighing and blending are critical steps that directly impact the final preparation's quality.

Conclusions:

  • Adherence to USP guidelines, particularly Chapter 905, is essential for pharmacists in drug compounding.
  • Preventing errors in weighing and blending is paramount to ensuring the integrity of compounded capsules and tablets.