Dosage forms challenges

Identification testing of pharmaceutical compounds is one of the more interesting types of tests for formulated products in the QC laboratory. Both the physical and chemical properties of the molecule and dosage form challenge the analyst by requiring expertise in wet and instrumental chemistry to correctly identify the material under study. 

Nickerson B, editor. Sample preparation of pharmaceutical dosage forms challenges and strategies for sample preparation and extraction. New York Springer 2011. 

Behind the relatively straightforward compositional nature of ophthalmic solutions, suspensions, and ointments, however, lie many of the same physicochemical parameters that affect drug stability, safety, and efficacy, as they do for most other drug products. But additionally, specialized dosage forms present the ophthalmic product designer with some extraordinary compositional and manufacturing challenges. These... 

To challenge the ability of MR dosage forms to resist exposure to high ionic strength, the ionic strength of any of the above-mentioned media can be increased, typically with sodium chloride in the first instance. However, it must be said that the osmolarity in the GI tract rarely falls outside the range 50-600 mOsm/Nm and that if this range is exceeded an artefactual discrimination may result. 

In accordance with the provisions of the Dietary supplement Health and Education Act 1994, in the United States botanical dosage forms can be marketed as dietary supplements provided the label makes no medical claim however, structure-function claim is allowed. In most countries other than the United States, botanical preparations are regulated as drugs thus posing a different set of challenges. This fact must be taken into consideration in standard setting. 

Drugs can be beneficially used in therapy as solids, liquids, and gases. The form most commonly used in drug therapy is solid, followed by liquid and then gas. Liquid drugs can pose an interesting challenge in dosage-form development since many of the liquids are volatile substances and, as such, must be physically sealed from the atmosphere to prevent their loss. 

The in vivo approach overcomes some of these limitations because a single dosage form may be applicable to a large population of patients. Delivery in vivo, however, is fraught with considerably greater complexities and challenges than those encountered in the ex vivo approach. The in vivo approach must achieve delivery in the... 

The sterile solutions are filled in different sizes of vials and ampoules. One dosage form is lyophilized injection and filled in A-ml vials. To ensure the sterility during the aseptic processing, it was decided to revalidate the A-ml vials sterilization/depyrogenation cycle once in a year by one heat penetration study and endotoxin challenge test. 

The crystalline nature of these lipids provides challenges in the manufacture of certain types of food products. To address successfully these sometimes conflicting and demanding objectives, it is clear that specific encapsulation processes must be designed to formulate pure bioactive substances into their appropriate dosage forms and also to improve their overall efficacy and safety (Augustin and Hemar, 2009 McClements et al, 2008, 2009). 

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