Injectable products

The presence of faults is another element that may change the number of injection/ production wells required. 

Pour typical weU patterns for contaminant plume containment are described in Ref. 16. The first is a pair of injection-production weUs. The second is a line of downgradient pumping weUs. The third is a pattern of injection-production weUs around the boundary of a plume. The fourth, the double-cell system, uses an inner ceU and outer recirculation ceU, with four ceUs along a line bisecting the plume in the direction of flow. Two other methods of plume containment are bio filters and a fuimel-and-gate system, which are described in the in bioremediation section. 

Water-for-Injection, which is used for parenteral injection products. 

Preterm labour is the major cause of perinatal morbidity and mortality. Oxytocin antagonists offer an attractive approach to prevention. Chapter 7 reviews three decades of medicinal chemistry in this field. The peptide approach has resulted in valuable injectable products. Selectivity over the related vasopressin receptors and improvement in pharmacokinetic profile have been the key challenges for more recent non-peptide programmes, and these seem likely to yield orally available medicines. 

The first official injection (morphine) appeared in the British Pharmacopoeia (BP) of 1867. It was not until 1898 when cocaine was added to the BP that sterilization was attempted. In this country, the first official injections may be found in the National Formulary (NF), published in 1926. Monographs were included for seven sterile glass-sealed ampoules. The NF and the United States Pharmacopeia (USP) published chapters on sterilization as early as 1916, but no monographs for ampoules appeared in USP until 1942. The current USP contains monographs for over 500 injectable products [1]. 

The major clinical problem arising from IM injections is muscle or neuron damage, the injury normally resulting from faulty technique, rather than the medication. Most injectable products can be given intramuscularly, with a normal onset of action from 15... 

Buffer systems for parenterals consist of either a weak base and the salt of a weak base or a weak acid and the salt of a weak acid. Buffer systems commonly used for injectable products are acetates, citrates, and phosphates (see Table 2). Amino acids are being increasingly used as buffers, especially for polypeptide injectables. 

Dry powders for reconstitution as an injectable product may be produced by several methods filling the product into vials as a liquid and freeze-drying, aseptic crystallization followed by powder filling, and spray-drying followed by powder filling. A brief discussion of each follows. 

Sterility, freedom from pyrogens, and acceptably low level of extraneous particulate matter are critical quality attributes of all injectable products. Additional critical quality attributes depend on the clinical use of the product. For example, for IV, IM, and SC routes, isotonicity and physiological pH (7.4) are always desirable in order to minimize potential irritation upon injection. Other factors may preclude this, however. If the required dose of drug must be administered in a small volume, it may not be feasible to formulate an isotonic solution. Likewise, solubility or stability considerations may preclude formulation at physiological pH. This explains why formulation pH for injectable drugs varies from about pH 2 to about pH 11. 

Table 4 Maximum Amounts of Added Substances Permitted in USP Injectable Products... 

Class II recalls are those in which the use of or exposure to a product found in violation of the law may cause a temporary health problem that is reversible, or in which the situation would not cause serious adverse health consequences. Examples of this type of recall would include uncertainty of the sterility of an injectable product, Salmonella contamination of various types of oral dosage forms, inadequate directions for use, and improper buffering of solution for injection [20]. 

The Ogachi hot dry rock (HDR) field is situated at the northeast Japan and has been studied to produce geothermal electricity by Central Research Institute of the Electric Power Industry for 20 years. There are two injection/production wells (OGC-1 and -2) and an observation one (OGC-3). Two major feed zones were formed by hydro fracturing at depth of 700m and 1100m, where their temperatures are 170 and 210°C, respectively. 

Injection-production wells, in soil and ground water treatment, 25 835 Injection stretch blow molding, of food packaging, 18 50-51 Injection wells, 18 613... 

Y - Percent Ingredient in Uncooked, Injected Product B - Percent Injected Brine... 

Injection Production Sample Injection Standard Solution ... 

Local Reaction to Injectable Product Mild (Grade 1) Moderate (Grade 2) Severe (Grade 3) Potentially Life Threatening (Grade 4)... 

Antimicrobial preservatives are added to multiuse nonsterile liquids, ointments, and ereams, and sterile injectable products to protect them from microbial contamination that may be introduced inadvertently during use of the product (postmanufacturing). 

Injectable products, ophthalmic Pharmaceutical ingredients As above... 

All injectable products should be tested for endotoxin at release. 

J.A. Jones, I.R. Last, B.R MacDonald and K.A. Prebble, Development and transferability of near-infrared methods for determination of moisture in a freeze-dried injection product, J. Pharm. Biomed. Anal. 11, 1227-1231 (1993). 

Required by Austrian Regulatory Authorities for injectable products, life - lifetime Single-single dose only — inappropriate or no experience. 

Cefuroxime is only poorly absorbed from the gastrointestinal tract and so was originally only an injectable product, but a commercially successful new orally-administered cerufoxime ester product has been developed which has created a new surge in sales. This acetoxyethyl pro-drag form of cefuroxime is rapidly hydrolysed in the brash-border mucosal epithehal cells of the duodenum and small intestine, but requires special formulation so as to ensure efficient dissolution following investigation. 

Design Specifications for Water for Injection Production and Distribution... 

Additional media fill information for injection products manufactured in room no. is described in (provide attachment refer-... 

C.02.005 states the requirements for the use of automatic, mechanical, and electronic equipment, including computerized systems, and the foreword of the interpretation of regulation C.02.024 the requirements for the maintenance of backup data. The Canadian GMP code does not have correspondence to regulation 211.72, which states the requirements for the filters for liquid filtration used in the manufacture of injectable products. Nor does it cover requirements for the use of fiber-releasing or asbestos-containing filters. 

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