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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...
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,...
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: 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...
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...
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.

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Characterisation Data of common pharmaceutical excipient Powders and Tablets for Formulation Development.

Dingeman L H van der Haven1, Maria Mikoroni2, René Jensen2

  • 1University of Cambridge, Department of Materials Science & Metallurgy, 27 Charles Babbage Road, Cambridge, CB3 0FS, United Kingdom.

Scientific Data
|July 1, 2026
PubMed
Summary

This study provides crucial reference data on pharmaceutical excipients like micro-crystalline cellulose (MCC), dibasic calcium phosphate dihydrate (DCPD), and partially pre-gelatinised corn starch (PGS). The data aids in optimizing drug formulation design and production processes.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Excipients are vital for drug formulation performance and patient acceptance.
  • Key excipients include micro-crystalline cellulose (MCC), dibasic calcium phosphate dihydrate (DCPD), and partially pre-gelatinised corn starch (PGS).
  • Publicly available reference data for these essential pharmaceutical powders are lacking.

Purpose of the Study:

  • To generate a comprehensive data set for MCC, DCPD, and PGS.
  • To characterize individual powder grains, including particle size, crushing strength, and geometry.
  • To evaluate the mechanical properties of tablets formed from these excipients and their mixtures.

Main Methods:

  • Detailed characterization of individual excipient grains (MCC, DCPD, PGS).
  • Tablet compression using a compaction simulator.
  • Extensive mechanical testing of manufactured tablets.

Main Results:

  • An extensive data set detailing the physical properties of MCC, DCPD, and PGS has been compiled.
  • Mechanical properties of tablets made from these excipients and their mixtures were systematically evaluated.
  • The generated data provides a valuable reference for pharmaceutical applications.

Conclusions:

  • The presented data set serves as a critical reference for the pharmaceutical industry.
  • This information will support educators and process developers in drug formulation.
  • Availability of this data facilitates improved drug product design and manufacturing.