Unit-dose packaging systems

In hospitals and long-term cate units, unit-dose packages ate used mote and mote. This system aHows better control of the dispensed dmgs in institutional settings and precludes the dispensing of larger numbers of doses than needed. 

Some hospitals are using a bar code scanner in the administration of unit dose drugs. To use this system, a bar code is placed on the patient s hospital identification band when the patient is admitted to the hospital. The bar codes, along with bar codes on the drug unit dose packages, are used to identify the patient and to record and charge routine and PRN dm. The scanner also keeps an ongoing inventory of controlled substances, which eliminates the need for narcotic counts at the end of each shift. 

A change in the container closure system of unit dose packaging (e.g., blister packs) for nonsterile solid dosage fonn products, as long as the new package provides the same or better protective properties and any new primary packaging component materials have been used in and been in contact with CDER-approved products of the same type (e.g., solid oral dosage form, rectal suppository). 

Current challenges facing the development of these systems for macromolecules include moisture control, efficient powder manufacturing, reproducible powder filling, unit dose packaging and development of efficient reliable aerosol dispersion and delivery devices. 

Inhalation solution and suspension drug products are typically aqueous-based formulations that contain therapeutically active ingredients and can also contain additional excipients. Aqueous-based oral inhalation solutions and suspension must be sterile (21 CFR 200.51). Inhalation solutions and suspensions are intended for delivery to the lungs by oral inhalation for local or systemic effects and are used with a specified nebulizer. Unit-dose presentation is recommended for these drug products to prevent microbial contamination during use. The container closure system for these drug products consists of the container and closure and can include protective packaging such as foil overwrap. 

In the revised Q system, Qg is calculated by using the complete beta spectra for the radionuclides of ICRP Publication 38 (see Ref. [1.13]). The spectral data for the nuclide of interest are used with data from Refs [1.14,1.15] on the skin dose rate per unit activity of a monoenergetic electron emitter. The self-shielding of the package was taken to be a smooth function of the maximum energy of the beta spectrum (Fig. 1.2). Qg is given by... 

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