Package dose metering

Manufacture of immunological veterinary medical products Manufacture of medicinal gases Manufacture of herbal medicinal products Sampling of starting and packaging materials Manufacture of liquids, creams, and ointments Manufacture of pressurized metered-dose aerosol preparations for inhalation... 

Inhalation drug products include inhalation aerosols (metered dose inhalers) inhalation solutions, suspensions, and sprays (administered via nebulizers) inhalation powders (dry powder inhalers) and nasal sprays. The CMC and preclinical considerations for inhalation drug products are unique in that these drug products are intended for respiratory tract-compromised patients. This is reflected in the level of concern given to the nature of the packaging components that may come in contact with the dosage form or the patient. 

A change in the primary packaging components for any product when the primary packaging components control the dose delivered to the patient (e.g., the valve or actuator of a metered-dose inhaler). 

Inhalation drug products, also referred to as orally inhaled and nasal drug products (OINDPs including inhalation aerosols and solutions, nasal aerosols and sprays), have a high likelihood of packaging component-dosage form interaction,and therefore have individual USFDA guidance documents. As an example, consider the metered dose inhaler (MDI), shown... 

Additional multiple-unit containers are in widespread use such as collapsible tubes, metered-dose inhalers, and aerosol containers. The f/j / /AF provides standards for aerosols and containers used for aerosols in Aerosols, Metered-Dose Inhalers, and Dry Powder Inhalers (601) and Pharmaceutical Dosage Forms (1151). Commonly used for ointments and pastes, the collapsible tube container is often constructed of plastic, metal, or some lamination of plastic and metallic layers. Although such preparations can be packaged in jars or bottles, collapsible tubes can offer better protection from contamination and from environmental hazards. The metered-dose inhaler and aerosol container are other specific multiple-unit dosage form examples that are commonly fabricated from metal and are closely tied to the process of medication administration. " ... 

For the use of an inhaled medication (e.g., p2-agonists, corticosteroids, antivirals, cromolyn, etc.), it is crucial for the child and parents to understand the mechanism of the metered dose inhaler (MDI) or nebulizer, if used. The package insert should also be reviewed for information about the specific drug product. A decision may also need to be made as to whether a spacer may be needed for use with the medication canister. 

Repackage product and produce matching placebo Obliterate all product labeling and packaging matching placebo in identical container dosage system Metered-Dose Inhalers ... 

There are increasing pressures on the pharmaceutical industry to use environmentally friendly materials in products, which are biodegradable or recyclable and do no harm to the environment. Examples are the replacement of CFCs in pressurised metered dose aerosols and the replacement of polyvinyl chloride (PVC) for alternative packaging materials in some countries. Any special restrictions on the use of materials in the product need to be identified at the product design stage. The choice of appropriate materials to suit product, customer and environment may also have cost implications. 

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