Formulation design is crucial to ensure that our products meet quality expectations. By applying QbD principles, we can systematically understand the relationship between critical formulation factors and their impact on Critical Quality Attributes (CQAs). Key elements to consider: 1. Quality Target Product Profile (QTPP): Defines the desired quality characteristics of the final product. 2….
A pharmaceutical manufacturing process usually consists of a series of unit operations to produce the desired quality product. Unit operations may be executed in batch mode or in a continuous manufacturing process. A process is generally considered well-understood when: (1) all critical sources of variability are identified and explained (2) variability is managed…
Over the years, QbD’s focus has been on the process design, understanding, and control, as discussed in the ICHQ8 (R2) guidance. It should be emphasized that product design, understanding, and control are equally important. Product design determines whether the product is able to meet patients’ needs, which is confirmed with clinical studies. Product design…
The BCS categorizes drug substances into four BCS classes as follows: What is High Solubility? The highest dose strength of the drug can be dissolved in ≤ 250 mL of aqueous media at a pH from 1 to 6.8 (including pH = pKa, pH = pKa + 1 and pH = pKa-1) and a temperature of 37 °C ± 1 °C. What is High Permeability? The fraction…
Pharmaceutical formulations are the specific compositions and preparations of API (s) and excipients. These formulations are designed to ensure the safe and effective delivery of medications. There are several types of pharmaceutical formulations, each tailored to meet specific patient needs and drug characteristics. Here are some common types of pharmaceutical formulations: Tablets and Capsules:…
QbD, or Quality by Design, is a systematic approach to pharmaceutical development and manufacturing that aims to ensure product quality by design, rather than by testing and inspection after production. But the principle of QbD can be applied to all stages of the product lifecycle, from research and development to commercial production. Key Components…
Pharmaceutical formulation development is the process of developing and optimizing drug formulations for commercial production. It involves formulating drugs into various dosage forms to ensure their effectiveness, stability, and safety for patients. In the world of pharmaceuticals, formulation development plays a crucial role in bringing new drugs to market. This process involves the identification,…
The drug approval process in the United States is overseen by the Food and Drug Administration (FDA), which ensures that drugs marketed in the country are safe and effective. Here are the general steps involved: 1. Preclinical Testing Before testing on humans, drugs undergo extensive laboratory and animal testing to assess their safety and…
