Effect of triacetin and polyethylene glycol 400 on some physical properties of hydroxypropyl methylcellulose free films

Johnson, Keith L.; Hathaway, Royal D.; Leung, Pauline; Franz, Robert M.

doi:10.1016/0378-5173(91)90412-h

Cited by 41 publications

(6 citation statements)

References 13 publications

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“…The evaluation and the improving of water vapor permeability (WVP) of polymeric films, particularly those based on hypromellose (hydroxypropylmethyl cellulose or HPMC), has been the object of several investigations. Results suggested that the use of hydrophilic additive generally increase the water permeability, whereas hydrophobic substances are reported to possess a variable effect, probably depending on the chemical nature of the substances itself. However, hydrophobic additives can generate problems concerning disintegration and dissolution of the solid dosage forms .…”

Section: Introductionsupporting

confidence: 71%

Evaluation of methoxy polyethylene glycol‐polylactide diblock copolymers as additive in hypromellose film coating

Cespi

Casettari

Bonacucina

et al. 2013

Polymers for Advanced Techs

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This paper deals with a new application of diblock methoxy polyethylene glycol-polylactide block copolymers, a class of synthetic biomaterials largely studied in the pharmaceutical and biomedical fields owing to their favorable properties such as biocompatibility, biodegradability, low immunogenicity, and good mechanical properties. In this work, these materials were evaluated as additives for gastro-soluble pharmaceutical coating aimed to reduce film stiffness and water permeability. Two copolymers with different polylactide chain lengths were synthesized and characterized in term of molecular weight and solid-state properties. A series of free films with different hypromellose/copolymers ratio were prepared and characterized in terms of appearance, components miscibility, plasticity, and water vapor permeability. The obtained results demonstrate that copolymers effectively influence hypromellose film properties according to their concentration and molecular weight. Specifically, the addition of the copolymer with a molecular weight of 6.5kDa in a ratio hypromellose:polymer 5:1, allowed to obtain films with good appearance, improved plasticization, and water permeability properties. For higher molecular weight, copolymer or different ratios was not possible to observe the improvement of all the properties at the same time. The results also make possible to define the critical features to improve in order to use block copolymers as additive in hypromellose film coating. The availability of new water-soluble additives able to work as plasticizer and moisture sealer in polymeric films represents an important progress not only in the field of pharmaceutical coating but also in that of food coatings, as for example in the formulation of edible films

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Section: Introductionsupporting

confidence: 71%

Evaluation of methoxy polyethylene glycol‐polylactide diblock copolymers as additive in hypromellose film coating

Cespi

Casettari

Bonacucina

et al. 2013

Polymers for Advanced Techs

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“…However, after this concentration the moisture permeability of HPMC films increased with increasing concentrations. The reason for the initial influence, as attributed by other investigators, 16) could be due to the densification of the HPMC polymer films when smaller plasticizer molecules were added. In high PEG concentration range, PEG increases the diffusion coefficient of HPMC when the diffusion pathways become enlarged and passage of water vapour molecules is facilitated.…”

Section: Moisture Permeation Of Hpmc Filmsmentioning

confidence: 91%

An Investigation on the Influence of a Vinyl Pyrrolidone/Vinyl Acetate Copolymer on the Moisture Permeation, Mechanical and Adhesive Properties of Aqueous-Based Hydroxypropyl Methylcellulose Film Coatings

Kwok

Sunderland

Heng

2004

CHEMICAL & PHARMACEUTICAL BULLETIN

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Film coating of tablets is commonly used to protect the integrity of the core material against environmental factors, for taste masking or providing a tough and better quality finish to minimize possible damage from mechanical handling during high speed packing.1) In view of environmental health and safety issues, as well as the higher costs associated with organic solvents, aqueous film coating is currently the method of choice in the pharmaceutical industry. One of the most widely used polymers for aqueous film coating of tablets is hydroxypropyl methylcellulose (HPMC).2) Generally, to minimize coating time and maximize production efficiency, the lowest possible viscosity grade of the polymer is the preferred choice as a high solid content in the coating solution is possible and, thus less water needed to be removed. The sprayable solution viscosity for aqueous film coating should be in the range of 150 to 400 mPa s. The apparent viscosity of aqueous HPMC solution is related to the molecular weight of the HPMC polymer and lowering of the molecular weight reduces the physical properties of the film coat.3) The advantage of using low viscosity grade polymer is limited if film quality, such as vapour permeabililty and tensile strength, is compromised.Due to the brittleness of plain HPMC films, plasticizers are often included in HPMC coating formulations. The functions of a plasticizer include softening films, reducing brittleness, increasing flexibility and ductility. Plasticization can increase the segmental mobility of HPMC, resulting in depression of the glass transition temperature. 4) As plasticizers lower both the mechanical properties and glass transition temperature, their compatibility and concentration are very important in coating formulations. Over-plasticization can lead to increased diffusivity, 5) making the film coat a poor protector of its core. In high humidity environments, adsorbed water itself has a plasticizing effect. Another additive, polyvinyl alcohol (PVA), had been reported to interact with HPMC resulting in decreased diffusivity. 5)Mechanical properties, such as tensile strength or maximum tensile stress, elastic modulus indicating stiffness and rigidity, 6) tensile strain at breakage or elongation (%) and work of failure (energy) are often used to gauge the performance of the film. An ideal film coat should be hard and tough with a high tensile strength and elastic modulus, 7) as well as a large work of failure and moderate elongation before break.Film coating on a tablet should be in intimate and continuous contact with the substrate surface.1) Strong film-tablet adhesion is also essential for good quality coated tablets as poor adhesion not only indicates visible film-coating defects but also affects the stability of moisture sensitive drugs and compromises the level of mechanical protection the film coat confers to the core. Evaluation of the adhesion characteristics provides useful information on the internal stress in films and film coating defects.8) The adhesiveness of film coa...

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“…In the present study, T g value of polymeric films containing 20% w/w PEG 400 in Surelease dispersion was observed to be 298C, which is lower than the T g value of Surelease dispersion (34.98C) reported previously, [19] which substantiates the proposed hypothesis. Johnson et al [22] have reported that PEG 400 at 20% level decreased the glass transition temperature of hydroxypropyl methylcellulose significantly. In the present study, since the product-bed temperature was maintained between 40 and 458C, it resulted in a temperature, which was 10 -158 above glass transition temperature of the PEG 400 -Surelease mixed polymeric formulation.…”

Section: Resultsmentioning

confidence: 98%

Influence of Type and Level of Water-Soluble Additives on Drug Release and Surface and Mechanical Properties of Surelease® Films

Rohera

Parikh

2002

Pharmaceutical Development and Technology

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Ethylcellulose in combination with water-soluble additives has been used in the development of microporous membrane-coated dosage forms. In the present study, application of three types of water-soluble additives, namely polyethylene glycols (PEG 400, 3350, and 8000), maltodextrins (Maltrin M150, M100, and M040 in the order of lower to higher average polymer size and molecular weight; dextrose equivalence 16.9, 11.1, and 4.8, respectively), and xylitol, as porosity modifiers in the films of a commercially available aqueous ethylcellulose dispersion (Surelease/E-7-7060 plasticized with glyceryl tricaprylate/caprate) was investigated. The effect of type and level of these additives on drug release characteristics and surface and mechanical properties of the polymeric films was studied. Each additive was incorporated at 20 and 30% levels in the polymeric dispersion based on its solids content. Ibuprofen tablets were coated using the polymeric dispersion with and without additive at 3% w/w coat level in a fluid-bed equipment. The coated tablets were evaluated for their drug release rate, coat reflectivity (gloss), Brinell hardness, and elastic modulus. Differential scanning calorimetric analysis of the films was performed to determine the physico-chemical changes in the applied film-coats. The rate of drug release, hence film porosity, was observed to be dependent on the type and level of the additive added. The molecular weight of the additive and its concentration in the polymeric dispersion had significant influence on the rate of drug release, hardness, and elasticity of the film-coats.

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Effect of triacetin and polyethylene glycol 400 on some physical properties of hydroxypropyl methylcellulose free films

Cited by 41 publications

References 13 publications

Evaluation of methoxy polyethylene glycol‐polylactide diblock copolymers as additive in hypromellose film coating

Evaluation of methoxy polyethylene glycol‐polylactide diblock copolymers as additive in hypromellose film coating

An Investigation on the Influence of a Vinyl Pyrrolidone/Vinyl Acetate Copolymer on the Moisture Permeation, Mechanical and Adhesive Properties of Aqueous-Based Hydroxypropyl Methylcellulose Film Coatings

Influence of Type and Level of Water-Soluble Additives on Drug Release and Surface and Mechanical Properties of Surelease® Films

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