Pharmaceutics Overview

Study Notes

Pharmaceutics is the discipline of pharmacy that deals with the development, formulation, and manufacturing of pharmaceutical products.
It involves the application of pharmaceutical sciences to design, develop, and test pharmaceutical products.

Pharmaceutical formulation: The process of combining active pharmaceutical ingredients (APIs) with excipients to create a dosage form.
Dosage form: A physical form of a pharmaceutical product, such as a tablet, capsule, or injection.
Excipients: Inert substances added to APIs to enhance their stability, bioavailability, and patient acceptability.
Pharmaceutical manufacturing: The process of producing pharmaceutical products on a large scale, involving various stages such as mixing, granulation, and packaging.

Physicochemical properties: Solubility, pH, and particle size of the API.
Biopharmaceutical properties: Absorption, distribution, metabolism, and excretion (ADME) of the API.
Formulation factors: Excipients, dosage form, and manufacturing process.

Preformulation: Characterization of the API and selection of excipients.
Formulation development: Design and optimization of the dosage form.
Manufacturing process development: Scale-up and validation of the manufacturing process.
Quality control and assurance: Testing and evaluation of the pharmaceutical product to ensure its quality, safety, and efficacy.

Good Manufacturing Practices (GMPs): Guidelines for ensuring the quality of pharmaceutical products.
Current Good Manufacturing Practices (cGMPs): Updated guidelines for pharmaceutical manufacturing.
Regulatory agencies: FDA (USA), EMA (Europe), and other national regulatory agencies that oversee the development and approval of pharmaceutical products.

Pharmaceutics involves development, formulation, and manufacturing of pharmaceutical products, applying pharmaceutical sciences to design, develop, and test pharmaceutical products.

Pharmaceutical formulation combines active pharmaceutical ingredients (APIs) with excipients to create a dosage form.
Dosage form refers to the physical form of a pharmaceutical product, such as a tablet, capsule, or injection.
Excipients are inert substances added to APIs to enhance stability, bioavailability, and patient acceptability.

Physicochemical properties include solubility, pH, and particle size of the API.
Biopharmaceutical properties include absorption, distribution, metabolism, and excretion (ADME) of the API.
Formulation factors include excipients, dosage form, and manufacturing process.

Preformulation involves characterization of the API and selection of excipients.
Formulation development involves design and optimization of the dosage form.
Manufacturing process development involves scale-up and validation of the manufacturing process.
Quality control and assurance involve testing and evaluation of the pharmaceutical product to ensure its quality, safety, and efficacy.

Good Manufacturing Practices (GMPs) are guidelines for ensuring the quality of pharmaceutical products.
Current Good Manufacturing Practices (cGMPs) are updated guidelines for pharmaceutical manufacturing.
Regulatory agencies, such as the FDA (USA) and EMA (Europe), oversee the development and approval of pharmaceutical products.