Water Distribution Studies Within Microcrystalline Cellulose and Chitosan using Differential Scanning Calorimetry and Dynamic Vapor Sorption Analysis

Agrawal, Anjali; Manek, Rahul V.; Kolling, William M.; Neau, Steven H.

doi:10.1002/jps.20085

Cited by 69 publications

(59 citation statements)

References 41 publications

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“…At a w * 0.90 a steep increase of water content was observed for the eucalyptus ball milled cellulose. GAB parameters for the recrystallized sample were also closer to the values previously reported for crystalline cellulose (Agrawal et al 2004;Rahman 1995;Van den Berg 1984), which supports the view that initial partial recrystallization occurred after heat treatment.…”

Section: Resultssupporting

confidence: 87%

The glass transition and crystallization of ball milled cellulose

et al. 2010

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Samples of ball milled cellulose were prepared by ball milling pulps from eucalyptus and softwood (spruce/pine). Water sorption isotherms were obtained by both dynamic vapor sorption and equilibration over saturated salt solutions, in the water content range of 5-42% db (db = dry basis; water as a % age of total solids). Dynamic mechanical analysis using a pocket technique showed a water content dependent thermal transition occurring at the same temperature for the two pulp samples, which was interpreted as a glass transition. Fitting the data to a Couchman-Karasz relationship predicted a value for T g of the dry cellulose of approximately 478 K, which was similar to values previously reported for other dry polysaccharides. No clear glass transition could be observed calorimetrically, although an endotherm at approximately 333 K was measured, which in polymers is normally attributed to enthalpic relaxation, however the lack of dependence of this endotherm on water content suggests that the melting of some weak associations, such as residual hydrogen bonds, could be a more credible explanation. An exotherm was also observed on heating, which was dependent on water content and which was attributed to partial crystallization of the cellulose. This was confirmed by Wide angle X-ray diffraction and cross polarization magic angle spinning 13C NMR (CPMAS NMR). The recrystallisation was predominantly to form I of cellulose. This was thought to be caused by a small amount of residual form I (probably less than 5%) acting as a template for the crystallizing material. Differential scanning calorimetry reheat curves showed the appearance of freezable water for water contents higher than 20%, as a result of a transfer of water to the amorphous phase following crystallization. The increase in cellulose rigidity following crystallization was also confirmed by CPMAS NMR relaxation. Low resolution proton NMR T 2 relaxation suggested the presence of proton water/cellulose exchange, which was active at water contents of 20% and above

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Section: Resultssupporting

confidence: 87%

The glass transition and crystallization of ball milled cellulose

et al. 2010

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“…Differential scanning calorimetry (DSC), has been successfully used to obtain information about the energies of water binding in various excipients and formulations (Yamauchi and Murakami 1991;Joshi and Topp 1992;Khankari et al 1992;McCrystal et al 1997McCrystal et al , 1999Bhaskar et al 1998;Ford 1999;Hatakeyama et al 2000;Agrawal et al 2003b). DSC testing involves the application of a constant heating or cooling signal to a sample and the subsequent measurement of the total heat flow response (Craig and Johson 1995).…”

Section: Analytical Techniques Used To Characterize Water In Solidsmentioning

confidence: 99%

“…There are a number of analytical methods that have been used to characterize moisture properties of pharmaceutical materials ( Hollenbeck et al 1978;York 1981;Zografi et al 1984;Khan and Pilpel 1987;Blair et al 1990;Begren 1994;Nokhodchi et al 1997;Rouquerol et al 1999;Lane and Buckton 2000;Achanta et al 2001b;Agrawal et al 2003b;Li et al 2003;Mihranyan et al 2004;Airaksinen et al 2005b;Sun 2008 Critical factor in predicting storage, stability, processing and application performance of pharmaceutical materials such as excipients, drug formulations and packaging films…”

Section: Analytical Techniques Used To Characterize Water In Solidsmentioning

confidence: 99%

“…Difference in the amount of heat required to increase the temperature of a sample and reference as a function of temperature Energies of water binding in various materials Fielden et al 1988;Yamauchi and Murakami 1991;Joshi and Topp 1992;Khankari et al 1992;McCrystal et al 1997McCrystal et al , 1999Bhaskar et al 1998;Ford 1999;Hatakeyama et al 2000;Agrawal et al 2003b;Heidarian et al 2006 Transition temperatures and enthalpies of sorbed water Identification of energetically distinct states of water,…”

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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“…During the last few years, several other excipients like crospovidone (9), carrageenan (10)(11)(12)(13), chitosan (14)(15)(16)(17), pectin (18)(19)(20), hydroxypropyl methylcellulose and hydroxyethylcellulose (21), Eudragit® (22), poly(ethyleneoxide) (23) and modified starch (24)(25)(26) were exploited as extrusion-spheronisation aid alternate to MCC.…”

Section: Introductionmentioning

confidence: 99%

Melt-in-Mouth Pellets of Fexofenadine Hydrochloride Using Crospovidone as an Extrusion–Spheronisation Aid

et al. 2010

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Abstract. Microcrystalline cellulose (MCC) is well established as an extrusion spheronisation aid for the preparation of pellets. Crospovidone (Polyplasdone® XL-10) is compared with microcrystalline cellulose for the preparation of melt-in-mouth pellets. Taste-masked fexofenadine hydrochloride was incorporated in the melt-in-mouth formulation. Crospovidone was found to be well suited as extrusion-spheronisation aid for the preparation of melt-in-mouth pellets. The great advantage of crospovidone is, however, the disintegrating properties of the pellets after only a short time of exposure to liquid. Crospovidone was successfully employed as an extrusion-spheronisation aid to produce melt-in-mouth pellets obviating the need of a traditional extrusion-spheronisation aid, MCC. Dual properties of Crospovidone were explored viz. as an extrusion-spheronisation aid and a disintegrant.

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Water Distribution Studies Within Microcrystalline Cellulose and Chitosan using Differential Scanning Calorimetry and Dynamic Vapor Sorption Analysis

Cited by 69 publications

References 41 publications

The glass transition and crystallization of ball milled cellulose

The glass transition and crystallization of ball milled cellulose

Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs

Melt-in-Mouth Pellets of Fexofenadine Hydrochloride Using Crospovidone as an Extrusion–Spheronisation Aid

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