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Excipients moisture content

In many products it seems highly probable that there exists a narrow range of optimum moisture contents that should be maintained. More specifically, the effect of moisture on MCC-containing tablets has been the subject of an investigation that demonstrates the sensitivity of this important excipient to moisture content [10]. These researchers found that differences exist in both the cohesive nature and the moisture content to two commercial brands of MCC. A very useful report on the equilibrium moisture content of some 30 excipients has been compiled by a collaborative group of workers from several pharmaceutical companies and appears in the Handbook of Pharmaceutical Excipients [11,12],... [Pg.294]

The original applications of NIR were in the food and agricultural industries where the routine determination of the moisture content of foodstuffs, the protein content of grain and the fat content of edible oils and meats at the 1% level and above are typical examples. The range of industries now using the technique is much wider and includes pharmaceutical, polymer, adhesives and textile companies. The first in particular are employing NIR spectrometry for the quality control of raw materials and intermediates and to check on actives and excipients in formulated products. Figure 9.26(b) demonstrates that even subtle differences between the NIR spectra of enantiomers can be detected. [Pg.395]

We now turn briefly to the problem of peptide stability in the solid state [8] [88], First, we note that most - if not all - reactions discussed in the previous and subsequent sections can also occur in the solid state, although the kinetics and mechanisms of the reactions can be quite different from those observed in solution. Moisture content, the presence of excipients that act as catalysts, and surface phenomena are all factors whose roles are all-but-im-possible to predict. As a result, each formulation poses a new challenge to pharmaceutical scientists. As a rule, solution data cannot be used to predict the shelf-life of solid formulations, and extrapolating from one solid formulation to another can be misleading. [Pg.307]

The Tandem system (Bruker Optics) is available for use during tablet production to measure tablet weight, thickness, hardness, and diameter, as well as online NIR content uniformity. The system can provide online analysis for drug substance uniformity, moisture content, and excipients. The advantage of systems like this is that the necessary data are available immediately to make adjustments to the production parameters in order to improve product rmiformity. Therefore, adjustments can be made to tablet weight in real time in order to achieve 100% of the label claim. [Pg.407]

Stability Residual moisture content—adsorbed moisture on excipient surface protects drug from hydrolytic degradation... [Pg.110]

The freezing of a product is a very important step. The structure in the frozen product decides whether the product can be freeze-dried at all and under which conditions it can be done. For this reason, the consequences of the freezing rate, layer thickness of the product and excipients are discussed in some detail. The second main point is the measurement and control of the two drying phases the main and secondary drying and the third concentrates on the residual moisture content, its measurement and the consequences during storage of the dry product. There will be critical opinions that some of the processes are unilaterally represented. aim was to show the, hmrts and the advantages ot certain procedures to enable the reader to decide whether the ideas of the quoted authors, or my own can be applied to his tasks. [Pg.285]

Information about excipients is useful in the initial planning and interpretation of the excipient compatibility results. Important factors to consider for excipients include their physical-chemical properties. The Handbook of Pharmaceutical Excipients lists important information on structure, moisture content, melting point, pH, solubility, and equilibrium moisture at variable relative humidity for individual excipients (27). An example of relevant physical-chemical parameters for some select excipients is detailed in Table 1. A spectroscopic review of excipients (28) has been completed, and extensive reviews of some of the most common types of excipients (i.e., carbohydrate based) are published (29). [Pg.422]

Excipient (common use) Moisture content Melting point pH Solubility % Equilibrium moisture at 75% RH... [Pg.423]

Figure 5 Effect of excipients on the storage stability of freeze-dried human growth hormone (hGH). Samples were stored for I month at 40°C. Solid bars, aggregation (primarily dimer). Hatched bars, chemical degradation via methionine oxidation and asparagine deamidation. The glass transition temperatures of the initial freeze-dried formulations are given above the bars when a gla.ss transition temperature could be measured by DSC. The glycine mannitol formulation is a weight ratio of hGH glycine mannitol of 1 1 5, the dex-tran formulation is 1 6 hGH dextran 40, none means no stabilizer, and the others are 1 1 hGH stabilizer. All formulations contain sodium phosphate buffer (pH 7.4) at 15% of the hGH content. Initial moisture contents are all ==1%. (Data from [4].)... Figure 5 Effect of excipients on the storage stability of freeze-dried human growth hormone (hGH). Samples were stored for I month at 40°C. Solid bars, aggregation (primarily dimer). Hatched bars, chemical degradation via methionine oxidation and asparagine deamidation. The glass transition temperatures of the initial freeze-dried formulations are given above the bars when a gla.ss transition temperature could be measured by DSC. The glycine mannitol formulation is a weight ratio of hGH glycine mannitol of 1 1 5, the dex-tran formulation is 1 6 hGH dextran 40, none means no stabilizer, and the others are 1 1 hGH stabilizer. All formulations contain sodium phosphate buffer (pH 7.4) at 15% of the hGH content. Initial moisture contents are all ==1%. (Data from [4].)...
Bell et al. [20] found, via differential scanning calorimetry, that the denatu-ration temperature of lyophilized bovine somatotropin and lysozyme decreased, and therefore stability decreased, with increasing moisture content. The denatura-tion temperature decreased with increasing moisture irrespective of the excipient. The magnitude of the decrease in denaturation temperature was, however, dependent on the type of excipient. [Pg.203]

Skrabanja et al. [28] reviewed the lyophilization of biotechnology products and emphasized that the final quality of a protein product is determined by an interplay between the proper choice of excipients and the freeze-drying process the glass temperature that defines the state of the freeze-dried cake can be influenced by the moisture content and the choice of the excipient. [Pg.204]

Hekman et al. [31] linked elevated moisture content to the formation of aggregates for a conjugated IgG lyophilized with maltose and citrate buffer. The increase in molecular size was a function of both the moisture content in the vial and the amount of time for which the sample was stressed thermally. The data suggest that the increase in molecular size as a function of thermal stress is due to attachment of maltase, which is a glucose disaccharide present in the lyophile as an excipient. This degradation pathway was only observed in the lyophile. [Pg.205]

However, high moisture does not always increase the adsorption of drugs onto the solid surface of excipients. For example, as to antibiotics with high interfacial energy and external location of adsorbed water, low moisture content is beneficial for achieving higher adsorption onto sorbitol. Overall, the mechanism by which moisture content affects the adsorption of drugs onto the solid surfaces of other excipients is very complex and can be affected by many factors. [Pg.35]

Kensler, T. Nash, R.A. Equilibrium moisture content of pharmaceutical excipients. Drug Dev. Ind. Pharm. 1982,... [Pg.1449]

Recombinant bovine somatotropin, lysozyme Both the excipient type (sucrose, sorbitol, glycerol) and moisture content affected protein degradation [30]... [Pg.1649]

The nature of moisture content determinations is perhaps best exemplified by the fact that the Handbook of Pharmaceutical Excipients lists 31 separate versions of laboratory tests to determine moisture content and one to determine equilibrium moisture content. These methods were used to assess the moisture content in the compilation of 148 monographs, many of which do not deal with solids. [Pg.2369]

NIRS is useful for the analysis of both raw materials and finished dosage forms. Qualitative determination of pharmaceutical raw materials using NIRS was reported as early as 1982. The largest variations in commercially produced excipients and actives appear to be in moisture content and particle size. These parameters may be monitored by NIRS with relative ease. Incoming substances may be tested for immediate identity confirmation on the receiving dock by inserting a fiber optic probe directly into the barrel. Spectral data for each lot of material purchased may be saved and added to the growing spectral reference library. [Pg.3634]


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See also in sourсe #XX -- [ Pg.77 , Pg.78 ]




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