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Water excipients with

Crowley and Martini [48] reported on several studies evaluating the impact of unit process operations on hydrates. AU showed some level of dehydration liberating freed crystalline water to participate in moisture-mediated reactions. The authors speculated that such energetic processing conditions are likely to have a similar affect on hydrated excipients with a potential deleterious effect on moismre-sensitive APIs. They commented that classical excipient compatibility studies were ill-equipped to predict such moismre-mediated interactions and that compression, attrition and other energy-intensive unit operations were rarely mentioned as requiring investigations. [Pg.30]

Dry blending of the primary powder material, i.e., active substance and auxiliary substances in a mixer. Preference should be given to demineralized water as granulating liquid and the excipients and the drug should show relatively low water solubility with the exception of the binder. The binder should be preferably added in a dry state as part of the powder components. [Pg.213]

Excipients both typically contain water and are required to interact with it. The water associated with excipients can exist in various forms. Studies with different materials have shown that water can exist in association with excipients in at least four forms that may be termed free water, bound water, structural water, and water of crystallization. Water associated with a particular excipient may exist in more than one form (26). The type of water will govern how it is implicated in interactions between the excipient and the API or another excipient. The so-called free water is the form that is most frequently implicated in excipient interactions. Bound water is less easily available for interaction, and structural water is usually the least available one. Water of crystallization can be very tightly bound into the crystal structure however, there are some comparatively labile hydrates, e.g., dibasic calcium phosphate dihydrate (see above). If water of crystallization remains tightly bound within the crystal structure, it is unlikely to participate in an excipient interaction. However, any material that is in equilibrium with air above 0% RH will have some free moisture associated with it. In reality, below about 20% RH, the amount of moisture will probably be insufficient to cause problems. However, if sufficient moisture is present (e.g., at a higher RH), it can facilitate the interaction between components of the formulation. [Pg.103]

The interaction of many excipients with water is an important property because the physiological fluids the medicine will encounter after administration are based on water. For example, we use the interaction between the tablet disinte-grant and water to facilitate the breakup of a conventional immediate release tablet or capsule in the stomach, and thereby aid the dissolution of the API. [Pg.104]

Overall, the concepts presented in this summary suggest that (i) an initial understanding of the properties of the API and excipients should be utilized to design excipient compatibility studies, (ii) the understanding of the role of water in the interactions of excipients with API should be considered for all designs of compatibility testing, and (iii) the physical form and its involvement in the solid state needs to be considered when interpreting the data. [Pg.452]

Coprocessed tablet excipient composed of chitin and silicon dioxide [52] Chitin is a water-insoluble hydrophilic polymer that can absorb water and function as a disintegrant. Due to the unacceptable flow and compression properties of chitin, coprecipitation with silicon dioxide was used to provide a new excipient with excellent flow, compaction and disintegration properties when compared to the individual components or commercially available direct compression fillers and disintegrants. The optimal composition of the coprocessed excipient contains a silicon concentration of about 50% (w/w). [Pg.88]

The phase diagrams of drug substance and excipients with water as well as the study of the temperature of glass transition (Fig. 24) are the basis of the choice... [Pg.3747]

Achanta AS, Adusumilli PS, James KW. Thermodynamic analysis of water interaction with excipient films. Drug Dev Ind Pharm... [Pg.305]

The sources of lipophilic/hydrophilic chemical exposure include environmental pollution (air, water, and soil contamination), pesticide, herbicide, and fertilizer residues in foods and drinking water, excipients (non-active additives such as colors, flavors, rheological agents, etc,) in foods and pharmaceuticals, industrial chemicals, household chemical products, personal care products, cosmetics, and environmentally synthesized chemicals that are formed from reactions with released chemicals with each other and with naturally present species. [Pg.625]

Freezing forms an amorphous solid of the protein and excipients with associated water in crystalline form. Annealing, an optional step, increases ice-crystal size and allows crystallization of bulking agents (such as glycine or mannitol), removing... [Pg.350]

Calteridol calcium is used as a chelating excipient in a parenteral formulation and was chosen as an example for two reasons. It contains water associated with a metal cation and thus represents a Class 3 hydrate. In addition, water is also contained in channels, as with the second example. What is unique about the calteridol system is that a single crystal structure has been solved for the tetra-decahydrate (reactant) and the tetra-dihydrate (product) using the same crystal. This procedure permits an interesting look not only into the structural differences but also into the energetic differences of the water environment through thermal analysis. A similar study was performed on the dihydrate and trihydrate phases of di-sodium adenosine 5 -triphosphate [25]. [Pg.156]

Water supports the growth of micro-organisms, therefore oral aqueous solutions, suspensions, emulsions and solubilisates in multidose containers should be preserved. Preservatives may be used for that purpose as well as excipients with preservative properties, such as propylene glycol. See Sect. 23.8 for extensive information on preservatives. Table 5.18 summarises preservatives with properties especially relevant for oral liquids. [Pg.87]

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). [Pg.68]


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