Related Experiment Video
Updated: May 26, 2026
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Overview of drug product development
1The Dow Chemical Company, Engineering Sciences, Solids Processing, Midland, Michigan, USA.
Current Protocols in Pharmacology
|December 8, 2011
Summary
This overview details the evolution of drug delivery systems, emphasizing the collaborative, multidisciplinary approach required for developing active pharmaceutical ingredient (API) dosage forms. It covers the journey from preformulation to commercial manufacturing.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery
- Formulation Development
Background:
- Drug delivery system development has advanced significantly over 20 years.
- This process integrates biology, chemistry, engineering, and pharmaceutics.
- Drug products (dosage forms) are crucial for administering active pharmaceutical ingredients (APIs).
Purpose of the Study:
- To provide an overview of approaches for creating small-molecule API dosage forms.
- To cover the entire development lifecycle from preformulation to commercial manufacturing.
Main Methods:
- Review of interdisciplinary approaches in drug delivery system development.
- Discussion of formulation strategies for small-molecule APIs.
Main Results:
- The development of drug products requires a rigorous, collaborative, and multidisciplinary scientific approach.
- Established methodologies exist for creating dosage forms for various stages, from preclinical testing to commercial use.
Conclusions:
- The creation of effective drug delivery systems is a complex process.
- Scientific rigor and interdisciplinary collaboration are key to successful formulation development and manufacturing.
Related Concept Videos
01:28Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
01:26Drug Administration and Therapy Phases: Overview
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
01:26Drug Discovery: Overview
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:22Biopharmaceutical 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...
01:28Biopharmaceutics and Pharmacokinetics: Overview
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the appropriate...