Pharmacopoeial Standards and Specifications for Pharmaceutical Aerosols: In-Process and Finished Products Quality Control Tests

Abstract

Pharmaceutical aerosol is a pressurized system that depends on the power of a compressed or liquefied gas to expel the contents from the container. Therapeutic performance of pharmaceutical aerosols is affected by various factors such as actuator tube design, orifice diameter, concentration of surfactant in the system, moisture content and deposition of emitted dose, vapor pressure of propellants, spray pattern, efficiency of valve crimping and measurement of particle size aerosols. Unique feature of this dosage form is the presence of propellants, whose properties like flash point, viscosity and density and presence of active ingredients, containers, valves and actuators also modify the aerosol performance. A pharmaceutical aerosol must satisfy certain standards to claim it to be a quality drug. The main standard for the quality of any drug is the intrinsic and extrinsic elements which contribute directly or indirectly to the safety, potency, efficacy, stability, patient acceptability and regulatory compliance of the products. In process quality control (IPQC) tests are performed in order to remove error from every stage in production. After the manufacturing process is complete finished product quality controls (FPQC) test are performed with respect to the specification of the pharmacopoeias with a view to checks that the quality parameters are within the acceptable limits or not. So, the total quality of pharmaceutical aerosols depends on both IPQC and FPQC tests. The objective of this study is to provide various in-process and finished product quality control tests for pharmaceutical aerosols as per pharmacopoeial standards and specifications.