Physiological compatibility

Toxicology tests in acute and chronic animal feed trials have shown no damage attributable to the PP that could be detected in the organs of animals, even after a two year trial. Skin and mucous membrane compatibility tests have shown no signs of irritation. 

Parts correctly manufactured from PP can meet the requirements specified by the relevant controlling bodies for pharmaceutical packing and medical articles. Once again, the suitability of the article for the intended application should be checked rather than the starting raw material. 

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Hydrazone of 1 -hydrazino-1 -hydroxy-4-phenyl-1,2-dihydro-3//-pyrido [l,2-c]pyrimidin-3-one was patented as cross-linkers for making physiologically compatible and H2O insoluble hydrazine or hydrazono compounds (97JAP(K)97/59303). 

Recently, efforts have been initiated to examine intrinsic host-guest chemistry in the solvent-free environment of a mass spectrometer. Of present interest are preliminary reports on perfluorinated hosts, crown ethers and cryptands, which are physiologically compatible and may possess important biological properties, such as the ability to carry oxygen and transport ions through membranes. Specifically, the oxygen-binding properties of... 

Various lecithin-based MEs were also characterized by Hasse and Keipert [131]. The formulations were tested in terms of their physicochemical parameters (pH, refractive index, osmolality, viscosity, and surface tension) and physiological compatibility (HET-CAM and Draize test). In addition, in vitro and in vivo evaluations were performed. The tested MEs showed favorable physicochemical parameters and no ocular irritation as well as a prolonged pilocarpine release in vitro and in vivo. 

Identification of pharmaceutically acceptable vehicles that afford sufficient solubilization while maximizing physiological compatibility for preclinical pharmacokinetic evaluation is critical. The most frequently used solubilization techniques include pH manipulation for ionizable compounds use of cosolvents such as PEG 400, ethanol, DMSO, and propylene glycol micellar solubilization with surfactants such as Tween 80 or SLS complexation with cylodextrins [40]. By using the solubilization techniques, the enhancement in solubility of poor water-soluble compounds can be significant compared to aqueous solubility and can facilitate the absorption of drug molecules in the gastrointestinal tract when delivered in solution form. 

The ion pairing approach involves coadministration of a hydrophilic or polar drug with a suitable lipophilic counterion, which consequently improves the partitioning of the resultant ion pair (relatively more lipophilic) into the intestinal membrane. In fact, the approach seems to increase the oral bioavailability of ionizable drugs, such as atenolol, by approximately 2-fold.However, it is important that a counterion possess high lipophilicity, sufficient aqueous solubility, physiological compatibility, and metabolic stability. Some of the successful applications of this approach have already been described in previous reviews " and therefore, will not be described any further here. 

Although the use of a buffer will aid in reducing the risk of precipitation upon dilution, there are pH, concentration and buffer type limitations. Physiological compatibility will depend on factors such as the route of administration, tonicity, and contact time. Other factors such as chemical stability as a function of pH must also be considered. Table 4 lists some marketed... 

For parenteral products it is necessary to ensure that the salt former is physiologically compatible and has a satisfactory toxicological profile. Salt formers that are suitable for use in oral products may not be satisfactory for parenteral use... 

The most important requirement is that the salt possesses sufficient solubility at physiologically compatible pH values to permit incorporation into the dosage form. Buffering the solution to an appropriate pH can often enhance solubility. Salts may also be prepared in situ in the formulation. This is particularly useful when the main route of administration utilizes the parent drug form. Where the aqueous solubility of the salt is not sufficiently high, co-solvents may need to be added to enhance solubility (e.g. propylene glycol is used as the vehicle in phe-nobarbitone sodium injection). Parenteral solutions based on co-solvent vehicles normally cannot be directly injected intravenously because there is the risk of precipitation at the injection site. Therefore, such products are diluted with isotonic saline or 5%w/v dextrose solution to produce a lower concentration that remains soluble and can be safely administered by infusion. Alternative delivery routes are by subcutaneous or intramuscular administration by which, in... 

Only a few surfactant systems and their derivatives have been explored as LLC-based drug delivery systems because of the chemical and physiological compatibility requirements listed above, and because of cost and availability issues. These LLCs include commercially available non-ionic surfactants such as esters of oleic acid and related fatty acids [e.g., glyceryl monooleate (GMO) (aka, monoolein)], and oligo(ethylene oxide)-alkyl ether surfactants (e.g.,... 

Overall, these results clearly show that MbPIXMn is a good candidate for a physiologically compatible HNO probe, while they also highlight the modulation of the reactivity of metallonitrosyl complexes toward O2 by a protein environment. 

Environmental, in the body Social - Implant mass is an important factor - Physiologically compatible, no allergies - High rate of loosening shortens life of implant, reducing the quality of life of patient due to surgical revisions - Traces (mg) of diesel oil enter the body - Calcium stearate as an anti-corrosion... 

In addition to being biocompatible and physiologically compatible, they must be inert other than in their function, i.e. they should not cause any inflammatory or toxic response. 

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