Containers dosage delivery devices

Type of dosage form Container with dosage delivery devices... 

Package Container Closure Design Glass Tube Dosage delivery devices Quality control... 

Besides discussing packaging forms such as bottles, tubes, strips and bags some generally used dosage delivery devices (Sect. 24.4.19), child-resistant containers (Sect. 24.4.20), containers for arthritic patients (Sect. 24.4.21) and stock containers (Sect. 24.4.18) are also... 

Dosage form Lantus is a sterile solution of insulin glargine for use as an injection. Each milliliter of Lantus contains 100 lU insulin glargine. Lantus is available in 5 ml and 10 ml vials and cartridges for use only in a proprietary insulin delivery device (pen). 

Dosage form NovoLog is a sterile, aqueous, clear, and colorless solution that contains insulin aspart 100 units/ml. NovoLog is available in 10 ml vials and 3 ml PenFill cartridges, each containing 100 units of insulin aspart per ml. NovoLog PenFill cartridges are for use with proprietary delivery devices and disposable needles. 

The physicochemical properties of the drug are critical in the design of the dosage form. Solubility, stability, and pH can strongly affect whether a drug can be delivered effectively from a controlled delivery device. Because sustained-release devices often contain multiple doses that if released immediately would reach toxic levels, the physicochemical properties and formulation process may have to be more tightly controlled compared with immediate-release systems. 

Primary container-closure system-related data will need to cover storage, transportation, and use. The choice of materials of construction, their description, and the ability of the container-closure system to protect from moisture and/or light will need to be considered. The compatibility of the container-closure and its contents will need to consider sorption, leaching, and safety. The performance of the container-closure system will also need to be considered in terms of dose delivery from any associated device that is to be supplied as part of the product. Container-closure components will require adequate specifications covering description, identification, critical dimensional tolerances, and test methodology (including pharma-copeial and noncompendial methods). More data are likely to be required for liquid or semi-liquid products than for solid dosage forms. In the latter, product stability data and container-closure system specifications may suffice. 

Solid oral dosage forms containing new chemical entities (NCEs) are commonly formulated into tablets or capsules as their first market image formulation. Subsequent drug product line extension development on these NCEs may evaluate more specialized drug delivery systems. Dissolution testing of standard oral tablets or capsules will commonly utilize the paddle or basket apparatus. In this chapter we focus primarily on the development and subsequent validation of dissolution testing methods that use these two devices. 

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