Parenteral guide

Appropriate resources should be consulted for compatibility and stability information before mixing components (e.g., manufacturer s information, Trissel s Handbook on Injectable Drugs, and King Guide to Parenteral Admixtures). 

The Guide to Inspections of Lyophilization of Parenterals, published by the US Food and Drug Administration, July 1993, contains among others the chapters Lyophilization Cycle and Controls , Cycle Validation and Lyophilizer Sterilization/Design . 

Preformulation testing provides a basic dossier on the compound and plays a significant role in identifying possible problems and suitable approaches to formulation. Such dossiers already exist for the common excipients. The requirement for aqueous solubility is paramount and preformulation can identify salt forms that are appropriate for further development. Stability and solubility studies wiU indicate the feasibility of various types of formulation such as parenteral liquids and their probable shelf lives. Similar information can be garnered for solid products from the solid physical properties. By performing these studies on a series of candidate compounds, the optimum compound can be identified and further biological and chemical studies guided to provide the best results. 

Intrauterine infusion (intra-amniotic or extra-amniotic) has been reported to be associated with fewer gastrointestinal symptoms and less fever than parenteral or intra-vaginal administration (122). In intra-amniotic use, the puncture must be guided by ultrasonography, and before injection a control aspiration of some amnio tic fluid is required in order to avoid intrauterine or intravascular injection. Uterine rupture has been described with intra-amniotic treatment. 

Aspartame is GRAS listed, and is accepted as a food additive in Europe and is in the FDA Inactive Ingredients Guide. It is included in non-parenteral medicines licensed in the UK, and is listed in the USP-NF, BP, JP, and EP. Aspartame is the subject of a monograph in the Food Chemicals Codex issued by the National Academy of Sciences. This document is very similar to the corresponding USP-NF monograph. 

Furthermore, the drafted guide suggests that the level of end-product testing for those products will depend on the associated risk connected to the scale of operation, shelf life of the product, frequency of preparation, as well as type of product (parenterals, orals) and type of facility where the product has been prepared. 

FDA Guide to Inspections ofLyophilization of Parenterals, Rockville, MD, Food and Drug Administration, July 1993. 

Catania, P.N. King Guide to Parenteral Admixtures King Guide Publications Napa, CA. 

Some compendial requirements have been instituted to guide packaging practices for drugs that are characterized by their route of administration. These guidelines are designed to enhance patient safety and prevent undesirable outcomes. The administrative modes discussed here include oral, parenteral, and topical. 

GRAS listed. Accepted as a food additive in Europe. Included in the FDA Inactive Ingredients Guide (injections, nasal, ophthalmic, and oral preparations). Included in parenteral and nonparenteral preparations licensed in the UK. 

GRAS listed. Included in the PDA Inactive Ingredients Guide (inhalations injections ophthalmic preparations oral capsules, solutions, suspensions, syrups, and tablets rectal topical, and vaginal preparations). Included in nonparenteral and parenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients. 

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