Prescription assessment product design

Preparations for cutaneous (or dermal) application may be used for local treatment as well as for transdermal administration with a systemic effect. The chapter focuses on preparations with a local effect and on design of formulation and method of preparation of those prepared in pharmacies. The interaction between skin, active substance and base, the anatomy of the skin and biopharmaceutical aspects of cutaneous preparations are discussed as well as the therapeutic effect of the base. Because of the important role of the pharmacist in prescription assessment some recommendations for the communication with the physician are given. One aspect is how to proceed with a request for the mixing of two licensed medicines or for the addition of an active substance or an excipient to a licensed product. The formulation design is generally following the several phases of the multicomponent preparations. Based on the... 

GPP touches upon the processes assessment of the physician s prescription or formulation design in the Documentation paragraph a pharmaceutical assessment of therapeutic rationale, safety data, toxicity, biopharmaceutical aspects, stability and product design should be carried out, before preparation takes place. No further details are established however. 

The ICH QIO guideline is developed as a PQS model for the whole life cycle of an industrially made product. It therefore starts with the design phase of the product and ends with product discontinuation. It does not include however the very first step the therapeutic issues (prescription assessment, benefit/risk balance) which are relevant for pharmacy preparations. 

Modem fire protection techniques have developed through multidiscipline activities in science and engineering and involve careful selection of materials, end-use product design and manufacture, and fire performance and risk assessment. Reducing the flammability of materials is still an essential primary fire safety consideration. PP is an inherently flammable material and therefore flame retardant treatment of the polymer is an essential consideration in relation to fire safety. For material scientists, however, it is also very important to be aware of developments in fire safety science and engineering including the transition from prescriptive to functional regulation of fire safety in many coimtries. 

---