Equilibrium Moisture Content of Pharmaceutical Excipients

Callahan, Julie; Cleary, Gary W.; Elefant, Milton; Kaplan, G.; Kensler, Terry T.; Nash, Robert A.

doi:10.3109/03639048209022105

Cited by 215 publications

(96 citation statements)

References 7 publications

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“…Hyteresis effect in sorption isotherms of aonla flakes has been described by Alam and Singh (2011). The freeze-dried powders show a high degree of hygroscopicity as their moisture uptake were greater than 50 % of their dry weight after storage for less than 1 week at RH of less than 90 % (Callahan et al 1982). The phenomenon of deliquescence is important in Freeze dried powders because the exposure of solids to high RH results in the formation of a liquid phase where chemical reactions may be accelerated or physical changes catalysed.…”

Section: Resultsmentioning

confidence: 99%

Moisture sorption characteristics of freeze dried whey–grape beverage mix

Varghese¹,

Radhakrishna²,

Bawa³

2012

J Food Sci Technol

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Moisture sorption isotherms of freeze dried whey-grape beverage powder were determined at 20, 30 and 40°C. A gravimetric static method was used under 0.11-0.85 water activity range and the sorption isotherms were found to be Type II. Various mathematical models were fitted to experimental data and it was found that Peleg model suits best in describing the equilibrium moisture content-equilibrium relative humidity relationships of instant whey-grape beverage mix over the range of temperatures studied. The net isosteric heat of sorption varied between 5.22 and 1.12 KJ/mol at moisture level varying between 1 and 9 % db. At moisture content below 1 % (db) the isosteric heat of sorption increased sharply for freeze dried whey-grape beverage powder and value of 49.08 KJ/mol was estimated.

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Section: Resultsmentioning

confidence: 99%

Moisture sorption characteristics of freeze dried whey–grape beverage mix

Varghese¹,

Radhakrishna²,

Bawa³

2012

J Food Sci Technol

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“…Water content of microorganism increases on exposure to high humidity conditions. Sorption of moisture from the atmosphere is primarily a physical process which could be adsorption, absorption, or occlusion [12]. The free water content is deleterious to the stability of B. coagulans spores and provides realistic picture of moisture stability of probiotics than the total water content.…”

Section: Moisture Gain Studymentioning

confidence: 99%

“…Disintegrants, are hygroscopic in nature [12], thus their blends show a high moisture uptake and a high water activity (about 0.6). Maximum reduction in the assay of B. coagulans was observed with disintegrants.…”

Section: Excipient Compatibility Studiesmentioning

confidence: 99%

Physicochemical Properties and Excipient Compatibility Studies of Probiotic Bacillus coagulans Spores

Bora¹,

Puri²,

Bansal³

2009

Sci. Pharm.

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The probiotic formulations are susceptible to loss in viability due to formulation, processing, storage and in vivo environment. The aim of the present study was to perform preformulation studies of probiotic Bacillus coagulans spores to aid designing of stable formulations. Bacillus coagulans spores were studied for hygroscopicity, resistance to compaction force, aqueous pH stability, and excipient compatibility. The spores were found to be moderately hygroscopic with a significant loss of microbiological assay at water activity value of more than 0.5. Progressive loss of viability from 95% to 58% was observed with increase in compaction force from 1000 to 4000 psi. Aqueous suspension of Bacillus coagulans spores in buffer solutions of pH 1.2 to 8 showed rapid degradation with maximal stablility in pH 6.8. Excipient compatibility studies showed reduced assay with citric acid monohydrate, meglumine and sodium starch glycolate. The loss of activity seemed to be related to the moisture uptake, free and bound water present in the bulk.

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“…2) show that the hygroscopic nature of feverfew extracts varied greatly with source. According to the hygroscopicity classification described by Callahan et al (12), the A1 and A2 extracts can be ranked as class III materials or moderately hygroscopic, where moisture content increased less than 5% after storage at below 60% RH and less than 50% increases in moisture content occur above 80% RH. Class III materials may or may not require special packaging depending on whether physical stability and appearance of the material are affected.…”

Section: Hygroscopicitymentioning

confidence: 99%

“…Hygroscopicity was evaluated by determining the equilibrium moisture content (EMC) of each commercial extract after storage at various relative humidities (RH) for 21 days based on method of Callahan (12). Desiccators containing saturated salt solutions and a 25°C precision temperature incubator were used to prepare chambers with relative humidity ranging from 8 to 84%.…”

Section: Moisture Content and Hygroscopicitymentioning

confidence: 99%

Selected Physical and Chemical Properties of Feverfew (Tanacetum parthenium) Extracts Important for Formulated Product Quality and Performance

2008

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Abstract. The objectives of this research are: (1) to assess selected formulation-relevant physical properties of several commercial Feverfew extracts, including flowability, hygroscopicity, compressibility and compactibility (2) to develop and validate a suitable extraction method and HPLC assay, and (3) to determine the parthenolide content of several commercial Feverfew extracts. Carr's index, minimum orifice diameter and particle-particle interaction were used to evaluate powder flowability. Hygroscopicity was evaluated by determining the equilibrium moisture content (EMC) after storage at various % relative humidities. Heckle analysis and compression pressure-radial tensile strength relationship were used to represent compression and compaction properties of feverfew extracts. An adapted analytical method was developed based on literature methods and then validated for the determination of parthenolide in feverfew. The commercial extracts tested exhibited poor to very poor flowability. The comparatively low mean yield pressure suggested that feverfew extracts deformed mainly plastically. Hygroscopicity and compactibility varied greatly with source. No commercial feverfew extracts tested contained the label claimed parthenolide. Even different batches from the same manufacturer showed significantly different parthenolide content. Therefore, extract manufactures should commit to proper quality control procedures that ensure accurate label claims, and supplement manufacturers should take into account possible differences in physico-chemical properties when using extracts from multiple suppliers.

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Equilibrium Moisture Content of Pharmaceutical Excipients

Cited by 215 publications

References 7 publications

Moisture sorption characteristics of freeze dried whey–grape beverage mix

Moisture sorption characteristics of freeze dried whey–grape beverage mix

Physicochemical Properties and Excipient Compatibility Studies of Probiotic Bacillus coagulans Spores

Selected Physical and Chemical Properties of Feverfew (Tanacetum parthenium) Extracts Important for Formulated Product Quality and Performance

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