Drug products dosage forms

Returned drug products 21 CFR 211.204— Records of returned drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned drug... 

For both the drug substance (bulk drug) and drug product (dosage form) stability information from accelerated and long-term testing should be provided on at least three batches with a minimum of 12 months duration at the time of submission. 

Biopharmaceutics is the study of the interrelationship of the physicochemical properties of the drug [active pharmaceutical ingredient, (API)] and the drug product (dosage form in which the drug is fabricated) based on the biological performance of the drug (Table 1). 

As described above, the pharmaceutical manufacturing process and end use of the drug product dosage form are the basis for establishing the limits of chemical purity and physical... 

It is not the aim of this article to evaluate formulation aspects that may influence dissolution of drugs from dosage forms. However, it suffices to mention that dissolution rates of drug substances or drug release from formulated products may be influenced (increased or decreased) by factors such as assay selection, the presence of surfactants, polymorphic modification, and by the use of water-soluble carriers in solid dispersions. 

A particular drug or dosage form may have features that rely on the presence of excipients for stabilization, delivery, or other performance parameters. Alternatively, the excipient may need to have additional features to render it suitable for the product in question... 

In the second stage, there was a realization that water could affect the chemical and physical properties of drugs and dosage forms. The fact that water might exist in different states was exemplified by partitioning the water into bound or free moisture. The implication was that the free, or solvent-like, moisture was responsible for most stability and production problems. ... 

Sale of a drug in dosage form is prohibited unless there is a responsible person for the drug in Canada. The responsible person s name and address must appear on the inner and outer labels. If the drug is imported into Canada, the importer s name shall appear on the labels also. The Drug Identification Number (DIN) and in the case of proprietary drugs, general product (GP) followed by the number must be printed on the labels. 

In practical terms, terminal sterilization of liquid parenteral products means sterilizaticMi by saturated steam. Production of free radicals in water prohibits the application of radiation sterilization to aqueous products, but radiation sterilization may be suitable for some solid dosage forms. Dry heat and ethylene oxide are unlikely to be of any value. In the first instance, therefore, saturated steam should be the process of first choice for sterilization of thermally stable drug substances dosage forms should not be formulated in ways that compromise thermal stability. 

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