Parenteral preparations infusions

Preservatives In addition to those processing controls mentioned above (Section 3.1.4.3), the sterility of a product may be maintained through the addition of antimicrobial preservatives. Preservation against microbial growth is an important aspect of multidose parenteral preparations as well as other formulations that require preservatives to minimize the risk of patient infection upon administration, such as infusion products [52], Aqueous liquid products are prone to microbial contamination because water in combination with excipients derived from natural sources (e.g., polypeptides, carbohydrates) and proteinaceous active ingredients may serve as excellent media for the growth [57], The major criteria for the selection of an appropriate preservative include efficiency against a wide spectrum of micro-... 

GRAS listed. Accepted for use as a food additive in Europe. Included in the EDA Inactive Ingredients Guide (injections ophthalmic preparations oral capsules, solutions, and tablets). Included in parenteral (intravenous infusions and injections) and nonparenteral medicines (ear drops eye lotions oral capsules, chewable tablets, effervescent powders, effervescent tablets, granules, and tablets suppositories and suspensions) licensed in the UK. 

The variability associated with drug absorption from the gastrointestinal tract can be overcome by using a parenteral preparation (dosage form). It should preferably be administered either by intravenous infusion or slow intravenous injection to avoid circulatory overload. Intraosseous administration is a useful alternative to intravenous injection of some antimicrobial agents (e.g. sodium ampicillin or amoxycillin, cefotaxime, ceftriaxone, gentamicin or amikacin sulphate) in neonatal foals (Fig. 7.1) (Golenz et al, 1994) and puppies (Lavy et al, 1995). This particularly applies when the neonate is in a state of septic shock and/or dehydration. Total plasma protein concentration is an inaccurate index of hydration status unless monitored (repeatedly measured) and interpreted in conjunction with packed cell volume (PCV). 

As a consequence, knowledge of photochemical stability and possible photochemical stability problems is of great importance in regard to parenteral preparations, especially infusions (see Table 14.1). Few systematic studies have been performed. Several factors can influence photochemical stability of dilute solutions and disperse systems, which constitute the main part of parenteral formulations. This chapter is focused on the different parameters that, theoretically, may influence photochemical stability of parenterals. Of course, the best way to stabilize the preparations is by preventing exposure to optical irradiation, an option not often accomplished in practice. Thus, it is valuable to know the factors that can influence photochemical stability of the products, as well as to prepare protocols for the management of parenterals at each hospital ward based on this knowledge. 

Parenteral preparations are filled into various types of containers, depending on the nature of the product. Single-dose injections are filled into glass ampoules sealed by fusion or ex tempore into plastic syringes. Multidose injections are delivered in glass vials sealed with rubber closures with mechanical properties suitable for multiple piercing. Concentrates and powders for injections or infusions are also... 

Parenteral preparations are regularly prepared aseptically a short time or immediately prior to administration. Compounds susceptible to hydrolysis or oxidative decomposition in solution are preferentially stored as dry powders, concentrates under an inert atmosphere, or in combination with stabilizers. Concentrates for injections or infusions (European Pharmacopoeia, 2002) are diluted prior to administration, usually with sterilized Water for injection (European Pharmacopoeia, 2002) or sterile, isotonic solutions of sodium chloride, glucose, dextran, or buffer (see Table 14.3). Powders for injections or infusions (European Pharmacopoeia, 2002) are dissolved or suspended in the same media. Vitamins are aseptically added ex tempore to TPN preparations due to poor stability and the risk of precipitation (Hutchinson, 1998), as are trace metals that may influence the stability of the TPN formulation. A limited number of drugs may also be dissolved in the TPN infusion prior to administration (Hutchinson, 1998). 

B. The propylene glycol diluent in parenteral preparations may cause myocardial depression and cardiac arrest when infused rapidly (> 40-50 mg/min [0.5-1 mg/kg/min]). The mechanism is not known. The injectable form of phenytoin also is highly alkaline and can cause tissue necrosis if it infiltrates. Fosphenytoin, a water-soluble prodmg, does not contain the propylene glycol diluent and does not cause these toxic effects. 

In the current years the delivery of macromolecules is explored as an alternative route of parenteral preparation, such as injections or infusions, with special attention to oral, buccal, and pulmonary delivery. Different applications of chitosan-based nanoblends for delivery of therapeutic macromolecules are provided herein [53]. 

The Ph. Eur. defines parenteral preparations as sterile preparations intended for administration by injection, infusion or implantation into the human or animal body . They are categorised as ... 

Parenteral preparations injection solutions, infusion solutions... 

For infusion bags PVC and PP are used. PVC- as well as PP-bags can be steam sterilised. Infusion bags have to meet the requirements of the Ph. Eur. for containers for parenteral preparations [32]. The Ph. Eur. also describes a test for the release of phthalates (plasticisers) from the PVC. This test has limitations and does not seem to predict every practical situation in practice the release may be much higher than is predicted by this test [40]. 

This concept has been applied successfully to the development of broad-spectrum antibiotics suitable for use in infections involving P-lactamase-producing organisms. A clinically useftil example is co-amoxiclav which is a mixture of amoxidllin (as the trihydrate or sodium salt) and davulanic add (as potassium davulanate) and is available as oral (tablet, oral suspension) and parenteral (intravenous infusion and injection) preparations. 

IV Do not administer undiluted potassium - Potassium preparations must be diluted with suitable large volume parenteral solutions, mixed well and given by slow IV infusion. 

To overcome the problem of DEHP leaching into parenteral infusions containing lipophilic components, a triple-layered tubing material has been used. This type of tubing is made of a PVC outer layer, while its innermost layer, which comes into contact with the drug solution, is made of inert PE. In spite of this arrangement, it has been shown that, depending on the preparation, DEHP from the PVC outer layer may be released in the infusion solution. 

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