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Related Concept Videos

Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
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.
Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
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,...
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...

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Related Experiment Video

Updated: May 24, 2026

Formation of Dispersible Taohong Siwu Tablets
05:44

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Formulation design, challenges, and development considerations for fixed dose combination (FDC) of oral solid dosage

Divyakant Desai1, Jennifer Wang, Hong Wen

  • 1Drug Product Science and Technology , Bristol-Myers Squibb Co., New Brunswick, NJ 08903, USA. divyakant.desai@bms.com

Pharmaceutical Development and Technology
|February 21, 2012
PubMed
Summary

Fixed dose combination (FDC) products combine multiple drugs into one pill, improving patient convenience and treatment outcomes for chronic conditions. This review explores FDC formulation trends and strategies for pharmaceutical scientists.

Related Experiment Videos

Last Updated: May 24, 2026

Formation of Dispersible Taohong Siwu Tablets
05:44

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Area of Science:

  • Pharmaceutical Science
  • Drug Delivery Systems

Background:

  • Fixed dose combination (FDC) products are increasingly utilized for managing complex diseases like hypertension, diabetes, HIV, and tuberculosis.
  • These products offer significant patient benefits, including enhanced convenience, reduced pill burden, and potential cost savings.
  • The aging global population necessitates polypharmacy, making FDC products crucial for simplifying treatment regimens and improving adherence.

Purpose of the Study:

  • To provide pharmaceutical scientists with an overview of current trends in fixed dose combination (FDC) product formulation development.
  • To present decision trees to guide the selection of optimal formulation development strategies for FDCs.
  • To highlight advanced formulation technologies relevant to FDC development.

Main Methods:

  • Review of recent literature and industry trends in FDC formulation.
  • Discussion of established and emerging formulation technologies for FDCs.
  • Inclusion of decision-making frameworks for formulation strategy selection.

Main Results:

  • The number of FDC products has steadily increased, indicating a continuing trend in pharmaceutical development.
  • Key formulation technologies like multi-layer tablets, multiparticulate systems, active film coating, and hot-melt granulation are detailed.
  • Specialized formulation technologies are also briefly introduced to broaden the scope.

Conclusions:

  • FDC products are vital for optimizing treatment and improving patient compliance, especially in aging populations with comorbidities.
  • The strategic selection of formulation technologies is critical for successful FDC product development.
  • Continued innovation in formulation science will drive the future growth and application of FDC products.