Galenical solutions

The galenical information describes the formulation (purity, stability, etc.) of the compound and the analytical method. For intravenous formulations the compatibility with infusion solutions and infusion set material should also be known. 

Certainly, every radiokinetic as well as any in vivo pharmacokinetic study depends on the galenic formulation used. Aqueous solutions, solutions with organic water-miscible components, solutions with surfactants, emulsions, micro emulsions or suspensions can be responsible for distinct differences of radiokinetics (pharmacokinetics). Therefore, a conscious choice of galenic vehicle and formulation procedure is critical ... 

In 1992, the decision was taken to introduce an EBRS in the galenical production of the pharmaceuticals division of F. Hoffmann-La Roche Ltd. in Basel, Switzerland. The project was launched as PK System in August 1994. By mid-1996, a major part of the system was in operation and working as intended. Back in 1992 there were no commercial systems available for this detailed functionality. Today there are several competitors working in this field. Some of the most important ones are Consilium, ProPack Data, SAP, and Werum. The implementation of a Commercial Off-The-Shelf (COTS) solution would have been the preferred option. 

Fabaceae and Plantaginaceae. When dissolved in water, saponins form soapy solutions and can therefore be used as detergents in the preparation of galenicals and cosmetics. Saponins can increase the permeability of biomembranes and may thus exhibit cytotoxic, haemolytic and antiviral properties most of them are highly toxic for fish. Moreover, steroid saponins are important starting materials for the commercial production of steroid hormones. 

Atropine and hyoscyamine mixture or in galenicals can be determined gravimetri-cally by precipitation with potassium tetraphenyl borate (66). Recoveries varying from 81.9 to 99.6% were obtained according to the volume of solution analysed. Reasonable results were obtained by reducing the volume of solution to 25 ml and with 10 to 25 mg alkaloids (atropine or hyoscyamine). The ratio atropine/hyoscyamine was determined by dissolving the alkaloidal tetraphenyl borate in 25% hydrochloric acid and measuring the specific rotation which is - 43 for hyoscyamine in this solvent (66). 

The preparation of Galene was simple in that its ingredients were free of fractional measures. Four vipers cut down small were placed in a solution of sal ammoniac, about one gallon, to which were added nine specified herbs and Attic wine, together with five fresh squills also cut down small. The pot was covered with clay and set upon a fire. When the vapour came out of the four small holes left in the clay seal, dark and turgid, the heat had... 

Emulsions, pharmaceutical Fever remedies Galenical preparations Hormone preparations, except diagnostics Insulin preparations Intravenous solutions Iodine, tincture of Laxatives Liniments Lip balms... 

The methods of assay for aneurine in complex galenicals have been developed from the original colorimetric or fluorimetric methods necessary for the small concentrations present in natural sources microbiological methods can also be used for small amounts. For tablets and injection solutions where the amounts are greater Adamson and Handisyde have shown that a gravimetric technique is more accurate. Titration in non-aqueous solvents is also applicable (see p. 792). 

A new approach to the Vitali type of reaction has been made by Freeman. After nitration the residue is dissolved in dimethylformamide and tetramethylammonium hydroxide is used for making alkaline. The recommended method, which can be applied to pure solutions containing hyoscyamine and related alkaloids or to their galenicals, after partial purification by the method of Allport and Wilson, is ... 

The extraction and estimation of small quantities of benzoic acid present as preservative may be required in the analysis of galenicals such as cough syrups. Several methods are available, the determination having received considerable attention because of the need for accurate assay for purposes of the Preservative Regulations. Direct extraction of the benzoic acid from acidified solution is not usually practicable and it is generally isolated by steam distillation. The technique followed is that of Monier-Williams. ... 

Cantharidin, C10H12O4, Mol. Wt. 196 2, may be extracted from galenicals in acid solution with chloroform. 

The purified extract or a prepared solution of the original material if of high nicotinic acid content or a simple galenical is then assayed colori-metrically. Hydrolysis of the amide, in which form the natural vitamin is usually present, is a necessary preliminary and a suitable technique is the following ... 

Garratt reported interference in the official method of the B,P, 1932 from some extracted non-morphine material in galenicals to which the method was applied. The extraneous material not only gave a brown colour with ammonia in the absence of nitrite, but this colour was a different tint from that of nitrosomorphine. In order to make the determination more accurate and a matching of the colours easier he proposed a method of compensating the blank solution, after making ammoniacal, with a quantity of test solution equal to that used in the test. 

Codeine is extracted from alkaline solution by chloroform and assay of its salt and galenicals is effected by normal alkaloidal extraction technique. Codeine phosphate, Ci8H2i03N,H3P04,l H20, Mol. Wt. 424-4, is official in the5.P., but the U.S.P, salt is a hemihydrate, Mol. Wt. 406-4, and this is the more usual commercial product. It may be determined by non-aqueous titration (see p. 792). 1 ml 0-1N perchloric acid = 0-03974 g Ci8H2i03N,H3P04 or 0 02994 g C,3H2i03N. 

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