Drug products preparations

Sample preparation refers to a family of solid/liquid handling techniques to extract or to enrich analytes from sample matrices into the final analyte solution. While SP techniques are well documented, few references address the specific requirements for drug product preparations, which tend to use the simple dilute and shoot approach. More elaborate SP is often needed for complex sample matrices (e.g., lotions and creams). Many newer SP technologies such as solid-phase extraction... 

This study will cover the range of 0.05-5% of compound X, impurity Y, and degradant Z in the drug product. Prepare five standard solutions at 0.05%, 0.2%, 0.5%, 2%, and 5% of the nominal concentration of compound X in the drug product and make one injection per preparation. 

One of the important requirements of any packaging material is that it should not release any component into the drug product. Preparation of containers free of any leachables such as monomeric component is especially important for the containers of ophthalmics, parenteral products, and any liquid products. It was shown that di(2-ethylhexyl) phthalate was released from the PVC bags and that caused haziness of the taxol solution (37), USP/NF offers the protocol of chemical, spectral, and water vapor permeation tests and tolerances for plastic containers (55). Among those, chemical test is designed to give a quantitative assessment of the extractable materials in both organic solvents and water. 

Bioavailahility studies are used to compare different formulations of the drug product, or different batches of the same formulation and, as discussed in Chapter 8, generic copies of a reference drug. Their comparative value is based on the premise that, if similar amounts of identical active substance are delivered to the site of action at similar rates, then a similar biological response can be expected, which leads to the conclusion that the two preparations are bioequivalent. 

In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. 

Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include ... 

Nebulizer formulation conforms to sterile product preparation, which means that drug stability in solution in the presence of additives must be evaluated. Historically, it was sufficient to use antimicrobial agents in the formulation, notably benzalkonium chloride. Adding antimicrobials is not now considered an acceptable approach to the formulation of nebulizer solutions. The solubility of the drug is important since it may impact upon the performance of the solution in a selected nebulizer. Additives may form complexes with the drug. 

To determine whether human testing for a new drug or new drug product is reasonable, it is first necessary to conduct preclinical studies and to submit the IND. The necessary information needed to prepare the IND is outlined in Table 1. The IND is to contain information on appropriate prior animal studies for safety evaluation, any available clinical data, adequate drug identification and manufacturing instructions, and a detailed outline of the proposed clinical study, routs of administration, approximate number of patients to be used, and an estimate of the length of treatment and an environmental impact statement. 

Description of the methods, facilities, and controls used to prepare and distribute the drug product... 

The business of BioZone Laboratories concerns development, manufacturing, and marketing of products and technologies, such as drugs and preparations, cosmetics, and nutritional supplements. All product lines are supported by proprietary technologies, and research and development activities are considered to be of a core importance for the business. The IP estate is also available for commercialization, particularly in the prescription area, for which several drug delivery systems and a prescription version of Inflacin were developed. 

General provisions contain recommendations that are considered the minimum current good compounding practices for the preparation of drug products by state-licensed pharmacies for dispensing or administration to humans or animals. The document contains definitions of compounding and manufacturing. 

Organization and personnel describe that in the dispensing of all prescriptions, the pharmacist has the responsibility and authority to inspect and approve or reject all components, drug product containers, closures, in-process materials, and labeling. It also has the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for fhe proper maintenance, cleanliness, and use of all equipmenf used in prescription compmmding practice. 

Labeling control of excess products explains that in the case where a quantity of a compounded drug product in excess of that to be initially dispensed in accordance with Subpart A is prepared, the excess product shall be labeled or documentation referenced... 

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