Parenteral preparations containers

Parenteral preparations containing fixed dose combination of streptomycin with penicillin. 

Trace elements Provide standard parenteral trace element preparation (containing zinc, copper, manganese, chromium, and selenium) daily in PN Assess patient for any possible adjustments needed (e.g., delete copper and manganese from PN if the patient has evidence of severe cholestasis, supplemental zinc and selenium for any Gl or fistula losses) or potential deficiencies... 

FIGURE 7 Influence of a lipid emulsion and daylight on peroxide levels in freshly prepared solutions of parenteral nutrition containing multivitamins (PN + MVI and PN + Lipid + MVI). (PN = parenteral nutrition MVI = multi vitamin preparation.) The data represent the mean SEM,n = 3 the variations are not depicted because of their small size relative to the symbols. The peroxide content rose significantly over time (P < 0.001), and exposure to daylight had a significant effect on peroxide generation (P < 0.001) [33]. 

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. 

For colored glass containers, not intended for parenteral preparations, the measured transmission must not exceed a maximum value of 10% at any wavelength between 290 and 450 nm, irrespective of the size or glass type. The limits for colored glass containers, used for parenteral preparations, depend on their intended fill volume. The respective limits for these containers are given in Table 1 (3,4). 

The use of cosolvents in small-volume parenteral preparations is often critical due to the limited volume of solution that can be administered by a single injection. Thus, the required dose of drug must often be incorporated in 1 or 2mL of solution. Table 6 lists parenteral products containing cosolvents. The cosolvents most often used include ethanol, propylene glycol, glycerin, PEG 400, and, sometimes, dimethylacetamide. Other cosolvents, such as DMSO, have been used as solvents for parenteral formulations of experimental anticancer agents however, their use is restricted due to toxicity and potential incompatibilities with plastic administration devices. ... 

Rubber for closures for containers for aqueous parenteral preparations and for powders for freeze-dried products. In European Pharmacopoeia, 3rd Ed. European Pharmacopoeia Commission Strasbourg, France, 1996Section 3.1.12 in 1999 Addendum. 

Emulsions are formulated for virtually all the major routes of administration, and there are a number of dermatological, oral and, parenteral preparations available commercially. The internal phase may contain water-soluble drugs, preservatives, and flavoring agents whilst the oil phase may itself be therapeutically active or may act as a carrier for an oil-soluble drug. Such preparations provide an effective approach to... 

USP These are soda-lime glass containers that are usually not used for parenteral preparations, except where suitable sensitivity test data indicates that Type III is satisfactory for the parenteral preparations that are packaged therein. ... 

For drug preparations that will be used for internal or mucous membrane administration (i.e., parenteral preparations, ophthalmics, creams and salves, etc.), additional testing must be performed to assure that any leachants will not cause biological reactions that may be detrimental to the patient. To do this, a test protocol has been established that screens materials used in containers to test for biological interactions. This protocol should be applied to any plastic container closure systems regardless of the type of container that will directly contact pharmacopeial preparations in storage before they are invasively used. This includes all closure systems for parenteral vials. ... 

The second type of container is the single-dose container. This container should contain a quantity designed for a single-parenteral preparation (not to exceed 1 L) and should contain a suitable antimicrobial additive. Larger packaging volumes may be used for compounds designed for use with hemofiltration, dialysis, or parenteral nutrition. 

The use of dimethyl sulfoxide to improve transdermal delivery has been reported for ciclosporin, timolol, and a wide range of other drugs.Dimethyl sulfoxide has also been used in the formulation of an injection containing allopur-inol. It has also been investigated for use in an experimental parenteral preparation for the treatment of liver tumors. ... 

Ethyl oleate is primarily used as a vehicle in certain parenteral preparations intended for intramuscular administration. It has also been used as a solvent for drugs formulated as biodegradable capsules for subdermal implantation and in the preparation of microemulsions containing cyclosporin. ... 

Polysorbates are widely used in cosmetics, food products, and oral, parenteral, and topical pharmaceutical formulations and are generally regarded as nontoxic and nonirritant materials. There have, however, been occasional reports of hypersensitivity to polysorbates following their topical and intramuscular use. Polysorbates have also been associated with serious adverse effects, including some deaths, in low-birthweight infants intravenously administered a vitamin E preparation containing a mixture of polysorbates 20 and 80. When heated to decomposition, the polysorbates emit acrid smoke and irritating fumes. 

Parenteral nutrition support therapy preparation contains ... 

FAT EMULSION For parenteral nutrition a fat emulsion for intravenous administration is used. Preparations contain a fractionated soya-oil emulsified with some fractionated egg phospholipids. About 60% of the fatty acids are essential fatty acids the particle size and biological properties are similar to those in natural chylomicrones. 

Photochemical reactivity of drug formulations is an important aspect to consider during development, production, storage, and use of pharmaceutical preparations. However, photochemical stability of drug substances is rarely as well documented as thermal stability of the compounds. For instance, in order to obtain a high sterility assurance level of the product, a parenteral preparation is sterilized in its final container if possible. Steam sterilization at minimum temperature of 121°C for... 

In busy hospital wards, the nursing staff often removes the outer cartons from parenteral products, and the preparations are stored without any protection against optical irradiation. In addition, ex tempore preparations are produced in the hospital pharmacy without outer protection and not usually protected when distributed to the wards (e.g., by use of aluminum foil) unless specifically instructed. According to the European Pharmacopoeia (2002), containers for parenteral preparations are to be made when possible from materials (usually glass or plastic materials) that are sufficiently transparent to permit visual inspection of the contents. As a consequence, the containers will offer no protection, or in some cases only limited protection, against photochemical decomposition of the drug substance or the formulation. 

Aqueous parenteral preparations can contain trace amounts of heavy metal ions in concentrations sufficient to catalyze oxidative reactions. Aqueous parenterals are produced with the use of Water for injection, which complies with the limit test for heavy metals (European Pharmacopoeia, 2002). This is, however, no guarantee for exclusion of metal ions. Heavy metal contamination brought into the formulation by excipients is also a problem, especially for sugars, phosphate, and citrate (Nema et al., 2002). Heavy metals may also be extracted from the container by the preparation (European Pharmacopoeia, 2002 see Section 14.3). Moreover, trace elements like zinc, copper, manganese, and chromium constitute important components in several parenteral nutrition formulas (Trissel, 2001). 

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... 

Plastic bags or bottles are commonly used as containers for aqueous parenteral solutions. Plastic containers are most frequently composed of polyethylene, polypropylene or poly(vinyl chloride) (European Pharmacopoeia, 2002). More than 60% of the plastic containers for parenteral preparations are made of the polyolefins (Fischer, 2002). Containers made of poly(ethylene-vinyl acetate) (EVA bags) are suitable as containers for TPN preparations because they do not have added plasticizers,... 

---