Moisture diffusion and permeability characteristics of hydroxypropylmethylcellulose and hard gelatin capsules

Abstract : The primary objective of this paper is to compare the sorption characteristics of hydroxypropylme-thylcellulose (HPMC) and hard gelatin (HG) capsules and their ability to protect capsule contents. Moisture sorption and desorption isotherms for empty HPMC and HG capsules have been investigated using dynamic vapour sorption (DVS) at 25 C. All sorption studies were analysed using the Young-Nelson model equations which distinguishes three moisture sorption types: monolayer adsorption moisture, condensation and absorption. Water vapour diffusion coefficients (D), solubility (S) and permeability (P) parameters of the capsule shells were calculated. ANOVA was performed with the Tukey comparison test to analyse the effect of %RH and capsule type on S,P, and D parameters. The moisture uptake of HG capsules were higher than HPMC capsules at all %RH conditions studied. It was found that values of D and P across HPMC capsules were greater than for HG capsules at 0-40 %RH; whereas over the same %RH range S values were higher for HG than for HPMC capsules. S values decreased gradually as the %RH was increased up to 60% RH. To probe the effect of moisture ingress, spray dried lactose was loaded into capsules. Phase evolution was characterised by scanning electron microscopy (SEM), X-ray powder diffraction (XRD), and differential scanning calorimetry (DSC). The capsules under investigation are not capable of protecting spray dried lactose from induced solid state changes as a result of moisture uptake. For somewhat less moisture sensitive formulations, HPMC would appear to be a better choice than HG in terms of protection of moisture induced deterioration.
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Ahmad Barham, Frédéric Tewes, Anne Healy. Moisture diffusion and permeability characteristics of hydroxypropylmethylcellulose and hard gelatin capsules. International Journal of Pharmaceutics, Elsevier, 2014, 478 (2), pp.796-803. ⟨10.1016/j.ijpharm.2014.12.029⟩. ⟨inserm-02379337⟩

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