Physical stability of redispersible dry emulsions containing amorphous sucrose.
The objective of the present study was to estimate the stability of redispersible dry emulsions containing amorphous sucrose. Dry emulsions were prepared by spray drying liquid o/w-emulsions in a laboratory spray dryer. The effect of hydroxypropyl methylcellulose (HPMC) on the glass transition temperature T(g) of spray dried sucrose-HPMC mixtures, relative to the T(g) of amorphous sucrose, was investigated. For the sucrose-HPMC mixtures the values of T(g) followed the ideal Gordon-Taylor equation up to 30% HPMC. For dry emulsions containing 40% HPMC, 30% lipid and 30% sucrose, the T(g) was increased by 12 degrees C relative to the T(g) of amorphous sucrose. The stability of the dry emulsions was investigated by a conventional stability study and by an enthalpy relaxation study. The measured enthalpy recovery of amorphous sucrose below T(g) was used to calculate molecular relaxation time parameters based on the Williams-Watts equation. The molecular mobility of amorphous sucrose at temperatures 50 degrees C below T(g) was low and negligible with respect to the shelf life stability. It was concluded that the dry emulsions are physically stable with respect to the lifetime of a pharmaceutical product when stored in dry condition and at temperatures up to 28 degrees C.
Christensen
K L
KL
Department of Pharmaceutics, The Royal Danish School of Pharmacy, Copenhagen, Denmark.
Pedersen
G P
GP
Kristensen
H G
HG
D002626:Chemistry, Pharmaceutical; D003890:Desiccation / Q000379:methods; D004355:Drug Stability; D004655:Emulsions / Q000737:chemistry*; D007785:Lactose / Q000031:analogs & derivatives* / Q000737:chemistry; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D010078:Oxazines; D011208:Powders; D013395:Sucrose / Q000737:chemistry*
D004655:Emulsions; D010078:Oxazines; D011208:Powders; D013395:Sucrose; D008747:Methylcellulose; C071191:MK 458; D007785:Lactose