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Active pharmaceutical interaction with excipients

The Committee for Proprietary Medicinal Products [8] applied the BCS, with certain requirements, to dispense with bioequivalency tests if the active pharmaceutical ingredient is class I and the in vitro dissolution of the finished dosage form is fast [9], An active substance is considered highly soluble if the amount contained in the HDS of an IR product is dissolved in 250 ml of each of three buffers within the range of pH 1-8 at 37°C (e.g., pH 1.0, 4.6, and 6.8). There should be linear and complete absorption, which indicates HP to reduce the possibility of an IR dosage form influencing the bioavailability [8], The similarity of the dissolution profiles of the test and reference products is demonstrated in each of three buffers within the range of pH 1-8 at 37°C (e.g., pH 1.0,4.6, and 6.8). If there is rapid dissolution of the product, where at least 85% of the active substance is dissolved within 15 min, no further comparison of the test and reference is required. Further requirements include that excipients be well established and have no interaction with the pharmacokinetics of the active substance and that the method of manufacture of finished product... [Pg.668]

Drug products contain both drug substance (sometimes referred to as the Active Pharmaceutical Ingredient [API]) and excipients. The resultant biological, chemical and physical properties of the dmg product are directly dependent on the excipients chosen, their concentration and interactions with the API [1]. [Pg.21]

Mendes, R.W. Anaebonam, A.O. Daruwala, J.B. Chewable tablets. In Pharmaceutical Dosage Forms Tablets, Lieberman, H.A., Lachman, L., Schwartz, J.B., Eds. Marcel Dekker, Inc. New York, 1989 I, 362-387. Richards, R.M. Xing, J.Z. Mackay, K.M. Excipient interaction with cetylpyridinium chloride activity in tablet based lozenges. Pharm. Res. 1996, 13 (8), 1258-1264. [Pg.2236]

Xylitol is highly chemically stable, meaning that it will not interact with pharmaceutical actives or excipients, and can be utilized over a wide pH range (pH 1-11). [Pg.827]

MPS have been widely used as excipients in pharmaceutical applications. Non-ordered MPS have also been utilized as functional excipients. As these application expanded, it was recognized that these materials could have interactions with the active drug substance. This property led to a new era of MPS uses in drug delivery applications. MPS drug delivery systems provide several functional applications when used in these systems. Figure 23.3 below describes this application space. [Pg.670]

Fig. 23.3 Silica functionalities as they relate to excipient applications and interactions with active pharmaceutical ingredients... Fig. 23.3 Silica functionalities as they relate to excipient applications and interactions with active pharmaceutical ingredients...
UV-Vis spectroscopy in solution is probably one of the most frequently applied spectroscopic methods in the quantitative analysis of pharmaceuticals (see other chapters of this book). In solid-state analysis, this situation is quite the opposite since most solids are too opaque to permit the use of this technique in the conventional transmission mode. UV-Vis spectroscopy on solids can only be realized via diffuse-reflection techniques connected with mathematical corrections (e.g. Kubelka-Munk function) and lacking the high reproducibility of UV-Vis spectroscopy in solution owing to particle dispersion effects. The number of published papers on the application of UV-Vis spectroscopy to solid pharmaceuticals is very small and these papers include topics such as photo-stabihty of dyes and active ingredients in tablets, drug-excipient interactions in dmg products, quantitative measurements on discolouration in dmg products, and others. For further reading we refer to Brittain [26] and the literature cited therein. [Pg.260]


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See also in sourсe #XX -- [ Pg.253 ]




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Active pharmaceutical

Activity pharmaceutics

Excipient

Excipient Interactions

Excipients

Pharmaceutical activity

Pharmaceutical excipients

Pharmaceuticals interactive

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