Stability parenteral

Wang, W. J. Chien, Y. W. Sterile Pharmaceutical Packaging Compatibility and Stability. Parenteral Drug Association, 1984, Tech. Rep. 5. 

Y John Wang, Yie W Chien. Sterile pharmaceutical packaging compatibility and stability. Parenteral Drug Association, Inc., Technical Report No. 5, 1984. 

The therapeutic utility of systemically administered ASON had been limited by their short plasma half life (sometimes even less than 3 min). This is due to their sensitivity to nuclease digestion. When the first-generation ASON were chemically modified, e.g., by replacing the oxygen in the phosphodiester bond with sulfur (phosphorothiorate) they obtained an increased stability in biological fluids while their antisense effect has been maintained. First-generation agents can be delivered via intravitreal injection, parenterally, by topical cream, enema, and inhaled aerosol. These antisense... 

VITAMIN S12. Fhtients with pernicious anemia are treated with vitamin B12 by tiie parenteral route (IM) weekly stabilized. The parenteral route is used because tiie vitamin is ineffective orally due to the absence of tiie intrinsic factor in tiie stomach, which is necessary for utilization of vitamin B12. After stabilization, maintenance (usually monthly) injections are necessary for life... 

M Jumaa, BW Muller. The effect of oil components and homogenization conditions on the physicochemical properties and stability of parenteral fat emulsions. Int J Pharm 163(1—2) 81—89, 1998. 

Improvement of the properties of a drug may be achieved by the chemical modification of the parent drug. The preparation of an ester, salt, or other modification of the parent structure may be employed with parenteral drugs to increase stability, alter drug solubility, enhance depot action, avoid formulation... 

If the solubility of a drug is to be reduced to enhance stability or to prepare a suspension, the for-mulator may prepare water-insoluble salts. A classic example is procaine penicillin G, the decreased solubility (7 mg/mL) of which, when compared with the very soluble penicillin G potassium, is utilized to prepare stable parenteral suspensions. Another alternative to preparing an insoluble drug is to use the parent acidic or basic drug and to buffer the pH of the suspension in the range of minimum solubility. 

Studies of polymorphs in recent years have pointed out the effects of polymorphism on solubility and, more specifically, on dissolution rates. The aspect of polymorphism that is of particular concern to the parenteral formulator is physical stability of the product [8]. Substances that form polymorphs must be evaluated so that the form used is stable in a particular solvent system. Physical stresses that occur during suspension manufacture may also give rise to changes in crystal form [9]. 

Salts of sulfur dioxide, including bisulfite, metasulfite, and sulfite, are the most common antioxidants used in aqueous parenterals. These antioxidants maintain product stability by being preferentially oxidized and... 

When oils are used as vehicles in ophthalmic fluids, they must be of the highest purity. Vegetable oils such as olive oil, castor oil, and sesame oil have been used for extemporaneous compounding. These oils are subject to rancidity and, therefore, must be used carefully. Some commercial oils, such as peanut oil, contain stabilizers that could be irritating. The purest grade of oil, such as that used for parenteral products, would be advisable for ophthalmics. 

An elastomeric closure is a packaging component that is, or may be, in direct contact with a drug product. Elastomer selection for parenteral packaging principally involves consideration of chemical, physical, and biological properties, with emphasis on the stability profile of the drug/container system. Typical elastomeric closure compositions are listed in Tables 1 1. Although certain packaging applications frequently call to mind certain elastomer types, it is not feasible to prescribe specific... 

Vacuum retention determines the ability of an elastomeric closure to maintain vacuum in a container-closure system when vacuum retention is a requirement. In certain instances it impacts on the long-term stability of a parenteral system. 

Y. J. Wang and M. A. Hanson, Parenteral formulations of proteins and peptides Stability and stabilizers. 

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). 

H. Bundgaard, C. Larsen, E. Arnold, Prodrugs as Drug Delivery Systems XXVII. Chemical Stability and Bioavailability of a Water-Soluble Prodrug of Metronidazole for Parenteral Administration , Int. J. Pharm. 1984, 18, 79-87. 

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