The influence of thermal treatment on the physical-mechanical and dissolution properties of tablets containing poly(DL-lactic acid).
Five molecular weight grades of poly(DL-lactic acid) (PLA) were incorporated as organic and aqueous pseudolatex binders into matrix tablet formulations containing microcrystalline cellulose and the model drug theophylline. The tablets were thermally treated to temperatures above and below the glass transition temperature (Tg) of the PLA. The results of the dissolution studies showed that thermally treating the tablets to temperatures above the Tg of the PLA significantly retarded the matrix drug release compared to tablets which were not thermally treated. The retardation in drug release could be attributed to a stronger compact and a more efficient redistribution of polymer throughout the tablet matrix, based on fundamental principles of annealing. In addition, results from tablet index testing supported the dissolution results. The bonding index of the compact formulations increased after thermal treatment above the Tg of the PLA. Gel permeation chromatography and differential scanning calorimetry studies demonstrated that thermal treatment had no significant effect on the molecular weight and the glass transition temperature of (PLA) alone and in combination with other components of the tablet formulation.
Omelczuk
M O
MO
Sandoz Research Institute, Sandoz Pharmaceuticals, East Hanover, New Jersey 07936.
McGinity
J W
JW
D002152:Calorimetry, Differential Scanning; D002850:Chromatography, Gel; D003692:Delayed-Action Preparations / Q000737:chemistry*; D007773:Lactates / Q000737:chemistry*; D019344:Lactic Acid; D008970:Molecular Weight; D011091:Polyesters; D011108:Polymers / Q000737:chemistry*; D012995:Solubility; D013696:Temperature
D003692:Delayed-Action Preparations; D007773:Lactates; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)