Evaluation of heat-conduction microcalorimetry in pharmaceutical stability studies (II) Methods to evaluate the microcalorimetric response

Angberg, M.; Nyström, Christer; Castensson, Staffan

doi:10.1016/0378-5173(90)90045-6

Cited by 24 publications

(13 citation statements)

References 7 publications

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“…Nuclear magnetic resonance (NMR) and FT Raman spectroscopy Nuclear magnetic resonance spectra Mobility of water molecules in a system Khan and Pilpel 1987;Martinez et al 1990;Suryanarayanan and Wiedmann 1990;Yoshioka et al 1992Yoshioka et al , 1995Aso et al 1994Aso et al , 1997Taylor et al 2001;McCrystal et al 2002;Suzuki and Kawasaki 2005 Strength of the hydrogen bonds with water Determination of plasticizing effect of water on polymer mobility, differentiation between samples in rubbery and glassy state Pikal et al 1977;Hollenbeck et al 1978;Angberg et al 1988Angberg et al , 1990Angberg et al , 1991Angberg et al , 1992aAngberg et al , 1992bFielden et al 1988;Buckton andBeezer, 1988, 1991;Pikal and Dellerman 1989;Blair et al 1990;Angberg 1995;Pudipeddi et al 1996;Buckton 2000 …”

Section: Analytical Techniques Used To Characterize Water In Solidsmentioning

confidence: 98%

“…the rate of heat production, with a sensitivity of about 10 4 greater than it is possible with a conventional DSC (Pikal and Dellerman 1989). In a series of publications (Angberg et al 1988(Angberg et al , 1990(Angberg et al , 1991(Angberg et al , 1992aAngberg 1995), the use of heat-conduction microcalorimetry in pharmaceutical stability studies was evaluated. The authors showed that, with the help of microcalorimetry, it was possible to detect the hydration process of anhydrous lactose after only one day of storage at 58 % RH.…”

Section: Analytical Techniques Used To Characterize Water In Solidsmentioning

confidence: 99%

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Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs

Rajabi‐Siahboomi

Levina²,

Upadhye

et al. 2015

Excipient Applications in Formulation Design and Drug Delivery

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Moisture sensitivity of active pharmaceutical ingredients (APIs) presents a formidable challenge in the formulation of oral dosage forms. The interaction of moisture with APIs is crucial to an understanding of water-based processes, e.g. manufacturing or prediction of solid dosage form stability and shelf-life. Unwarranted moisture sorption by either APIs or excipients can result in unstable oral solid formulations. The appropriate selection of excipients for the core formulation and appropriate moisture barrier film coating helps to remedy the moisture-related issues with APIs and thus can improve the storage stability of the final formulations. In this chapter, we review the nature and extent of the moisture sensitivity and possible approaches taken to overcome it. Use of excipients that bind tightly with water reduce its potential interaction with the API. In addition, application of a barrier coating to reduce rate and extent of moisture ingress into the core of the solid dosage form during the storage (in original packaging or while in-use), are some of the many simple options that have been considered and described.Keywords Calorimetry · Degradation · Differential scanning calorimetry · Dynamic vapor sorption · Equilibrium relative humidity · Excipients · Isothermal microcalorimetry · Moisture · Moisture-barrier coating · Near-infra red Spectroscopy · Opadry · Optical waveguide spectroscopy · Packaging · Stability · Water · Water vapor transmission rate Abbreviations AluAluminum API Active pharmaceutical ingredient

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Section: Analytical Techniques Used To Characterize Water In Solidsmentioning

confidence: 98%

Section: Analytical Techniques Used To Characterize Water In Solidsmentioning

confidence: 99%

Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs

Rajabi‐Siahboomi

Levina²,

Upadhye

et al. 2015

Excipient Applications in Formulation Design and Drug Delivery

View full text Add to dashboard Cite

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“…Thermodynamic analysis of the observed heat effects that permits quantitative characterization of the energetic processes is associated with the binding reaction. ITC gives invaluable information about biomacromolecule-ligand interaction [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23], protein denaturation [24][25][26][27][28], allosteric transition [29][30], enzyme inhibition [31][32][33][34][35], quality, safety and shelf-life of materials and material stability [36][37][38][39][40][41]. Different methods have been reported for data analysis of ligand binding study by ITC [42][43][44][45][46][47][48][49][50][51][52]…”

Section: Introductionmentioning

confidence: 99%

A review on the ligand binding studies by isothermal titration calorimetry

Saboury

2006

JICS

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Thermodynamics of biomacromolecule ligand interaction is very important to understand the structure function relationship in proteins. One of the most powerful techniques useful to obtain additional information about the structure of proteins in biophysical chemistry field is isothermal titration calorimetry (ITC). An ITC experiment is a titration of a biomacromolecule solution by a solution containing a reactant (ligand) at constant temperature to obtain the exchanged heat of the reaction. The total concentration of ligand is the independent variable under experimental control. There are many reports on data analysis for ITC to find the number of binding sites (g), the equilibrium constant (K), the Gibbs free energy of binding process (ΔG), the enthalpy of binding (ΔH) and the entropy of binding (ΔS). Moreover, ITC gives information about the type of reaction, electrostatic and hydrophobic interactions, including determination of cooperativity characterization in binding process by calculating the Hill coefficient (n). A double reciprocal plot and a graphical fitting method are two simple methods used in the enzyme inhibition and metal binding to a protein. Determination of a binding isotherm needs more ITC experiments and more complex data analysis. Protein denaturation by ligand includes two processes of binding and denaturation so that ITC data analysis are more complex. However, the enthalpy of denaturation process obtained by ITC help to understand the fine structure of a protein.

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“…There is a dearth of discussion in the literature on the effects of test sample preparation methods on the heat-flow results. For example, in the case of polymer samples, tests have been carried out on specimens that were molded from the stock, 8 cut, machined, and punched from the stock, 13,16,18,19 or simply cut from the stock. 20 For UHMWPE, it may be feasible to obtain test samples through microtoming the stock.…”

Section: Experimental Designmentioning

confidence: 99%

Use of isothermal heat‐conduction microcalorimetry (IHCMC) for the evaluation of synthetic biomaterials

Lewis

Daniels

2003

J Biomed Mater Res

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Isothermal heat-conduction microcalorimetry (IHCMC) allows measurement of extremely small rates of heat flow-on the order of 0.1 microwatt. This provides, for example, the ability to directly observe-and quantitate in a few days-rates of degradation as low as 1% per year at body temperature, in solid material samples of a few grams. Also, one method of IHCMC data analysis allows direct determination of the reaction-rate constant at the temperature of interest, thereby avoiding possible errors due to rate mechanism changes with temperature, an issue that needs to be considered when the Arrhenius method is used. IHCMC can also be used to measure transient phenomena, such as heat of adsorption, and initial metabolic responses of cellular entities to biomaterials. The purposes of this review article are to (a) explain the basic principles, attractive features, limitations, and methods of IHCMC; (b) describe biomaterials applications to date-including studies of the stability of ultra-highmolecular-weight polyethylene and implant-grade calcium sulfate, setting reactions of dental adhesives, and macrophage response to biomaterial particles; (c) provide a discussion of issues and concerns that should be addressed in order to maximize the utility of IHCMC in biomaterials studies; and (d) suggest a number of possible future biomaterials applications for this technique.

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Evaluation of heat-conduction microcalorimetry in pharmaceutical stability studies (II) Methods to evaluate the microcalorimetric response

Cited by 24 publications

References 7 publications

Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs

Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs

A review on the ligand binding studies by isothermal titration calorimetry

Use of isothermal heat‐conduction microcalorimetry (IHCMC) for the evaluation of synthetic biomaterials

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