Evaluation of release from selected thermosoftening vehicles.
Release of D&C Yellow No. 10 and anhydrous theophylline have been determined from a thermosoftening, hydrophilic matrix, Gelucire 50/13, incorporating a water-soluble additive, polyethylene glycol 4000. As additive level increased, release also increased. The effect of mixtures of Gelucire 50/13 (G50/13) and Gelucire 50/02 (G50/02) on release was also investigated as a function of temperature and pH. As the level of G50/02 increased, release decreased and became predominantly diffusional. As temperature was increased, release changed from diffusion to a mixed model of both diffusion and erosion. At basic pH, release from these composite systems became more erosional in character, possibly reflecting partial hydrolysis of the ester-linked matrices. Diffusion coefficients and apparent diffusion coefficients were calculated in G50/02 and G50/13 matrices, respectively, and were in agreement with published data.
Schering-Plough Research, Kenilworth, NJ 07033.
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D002152:Calorimetry, Differential Scanning; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D005223:Fats / Q000737:chemistry; D009821:Oils / Q000737:chemistry; D014677:Pharmaceutical Vehicles; D011092:Polyethylene Glycols; D011804:Quinolines
D003692:Delayed-Action Preparations; D005223:Fats; D009821:Oils; D014677:Pharmaceutical Vehicles; D011804:Quinolines; C071184:Gelucire 50-13; C071183:Gelucire 50-02; C019303:quinoline yellow; D011092:Polyethylene Glycols