Glass parenteral preparations

I Highly resistant borosilicate glass Parenteral preparations... 

Distilled water is often used in the formulahon of oral and topical pharmaceutical preparations and a low bacterial count is desirable. It is also used after distillation with a specially designed still, often made of glass, for the manufacture of parenteral preparations and a post-distillation heat sterilization stage is commonly included in the process. Water for such preparahons is often stored at 80°C in order to prevent bacterial growth and the production of pyrogenic substances which accompany such growth. 

II Treated soda-Ume glass Acidic or neutral parenteral preparations... 

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 residual transmission of brown glass is recognized by both the European and the U.S. Pharmacopoeia. UV-VIS transmission values up to 10% are acceptable. In the case of parenteral preparations transmission values up to 50% are acceptable, depending on the product s fill volume. 

USP describes Type I glass as highly resistant borosilicate glass, and usually used for packaging acidic and neutral parenteral preparations. Also, where stability data demonstrates their suitability. Type I are used for alkaline parenteral preparations. ... 

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. ... 

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. 

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... 

Radiopharmaceuticals for parenteral use must comply with the Ph. Eur. mmiograph for parenteral preparations, so they have to be sterile and with a very low or absent endotoxin COTicentration. For parenteral administration a sterile injectirm in a disposable injection syringe is often filled from a multiple dose solution in a glass vial. 

EP describes Type I glass as neutral glass with high hydrolytic resistance owing to the chemical composition of the glass itself. Type I is suitable for all preparations whether or not for parenteral use and for human blood and blood components. ... 

EP Soda-lime silica glass with high hydrolytic resistance resulting from suitable treatment of the surface. These containers are suitable for acidic and neutral aqueous preparations for parenteral use. ... 

EP These are soda-lime glasses with only moderate hydrolytic resistance. They are suitable for non-aqueous preparations for parenteral use, for powders for parenteral use, and for preparations not for parenteral use. ... 

The modern use of glass has been somewhat reduced by the advent of plastics. Despite the durability and cost-effectiveness of plastic containers, plastic has not permeated all pharmaceutical applications. Glass is still the most attractive packaging material where chemical inertness, very low moisture and gas permeability, and heat resistance are concerned. Modern uses of glass are typically restricted to injectable liquids for parenteral use ° and other sterile preparations. ... 

Sterile aqueous solutions prepared with high purity ascorbic acid and pyrogen-free distilled water in glass-lined equipment under absolute sanitary operations and filled into ampules are necessary for injectable solutions for parenteral use in humans and animals. For all injectable products, it is important to select container, stopper, preservative, and other ingredients that are compatible. 

The chemical stability of glass containers for pharmaceutical use is expressed by the hydrolytic resistance, i.e., the resistance to release of water-soluble mineral substances, evaluated by titrating the released alkalinity. According to the European Pharmacopoeia (2002), aqueous preparations for parenteral use are to be dispensed into glass containers of high hydrolytic resistance, while nonaqueous preparations and powders for parenteral use can be filled into glass containers of moderate hydrolytic resistance. It is obvious that release of alkaline substances may influence photochemical stability by an increase in pH (see Section 14.2.3). 

The release of aluminium from glass raises concern from the toxicological point of view. This is mainly relevant related to parenteral solutirms and not so much as to orally administered preparations. Aluminium is hardly absorbed in the gastrointestinal tract. Elimination of aluminium after parenteral administration occurs mainly via the kidneys. Patients having a high risk of aluminium intoxication are ... 

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