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Aqueous film coating to reduce recrystallization of guaifenesin from hot-melt extruded acrylic matrices.
Drug Dev Ind Pharm. 2010 Feb; 36(2):218-26.DD

Abstract

OBJECTIVES

This study investigated the effect of aqueous film coating on the recrystallization of guaifenesin from acrylic, hot-melt extruded matrix tablets.

METHODS

After hot-melt extrusion, matrix tablets were film-coated with either hypromellose or ethylcellulose. The effects of the coating polymer, curing and storage conditions, polymer weight gain, and core guaifenesin concentration on guaifenesin recrystallization were investigated.

RESULTS

The presence of either film coating on the guaifenesin-containing tablets was found to prolong the onset time of drug crystallization. The coating polymer was the most important factor determining the delay in the onset of crystallization, with the more hydrophilic polymer, hypromellose, having a higher solubilization potential for the guaifenesin and delaying crystallization for longer period (3 or 6 months in tablets stored at 40 degrees C or 25 degrees C, respectively) than the more hydrophobic ethylcellulose, which displayed a lower solubilization potential for guaifenesin (crystal growth on tablets cured for 2 hours at 60 degrees C occurred within 3 weeks, whereas uncoated tablets displayed surface crystal growth after 30 minutes). Crystal morphology was also affected by the film coating. Elevated temperatures during both curing and storage, incomplete film coalescence, and high core drug concentrations all contributed to an earlier onset of crystal growth.

Links

Publisher Full Text

Authors+Show Affiliations

Bruce CD
PharmaForm, LLC, Austin, TX 78758, USA. cbruce@pharmaform.com
Fegely KA
No affiliation info available
Rajabi-Siahboomi AR
No affiliation info available
McGinity JW
No affiliation info available

MeSH

Acrylic ResinsChemistry, PharmaceuticalCrystallizationDrug CarriersDrug CompoundingDrug StabilityDrug StorageExcipientsGuaifenesinPolymersSolubilityTablets, Enteric-CoatedTechnology, PharmaceuticalTemperatureWater

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19877992

Citation

Bruce, Caroline D., et al. "Aqueous Film Coating to Reduce Recrystallization of Guaifenesin From Hot-melt Extruded Acrylic Matrices." Drug Development and Industrial Pharmacy, vol. 36, no. 2, 2010, pp. 218-26.
Bruce CD, Fegely KA, Rajabi-Siahboomi AR, et al. Aqueous film coating to reduce recrystallization of guaifenesin from hot-melt extruded acrylic matrices. Drug Dev Ind Pharm. 2010;36(2):218-26.
Bruce, C. D., Fegely, K. A., Rajabi-Siahboomi, A. R., & McGinity, J. W. (2010). Aqueous film coating to reduce recrystallization of guaifenesin from hot-melt extruded acrylic matrices. Drug Development and Industrial Pharmacy, 36(2), 218-26. https://doi.org/10.3109/03639040903271277
Bruce CD, et al. Aqueous Film Coating to Reduce Recrystallization of Guaifenesin From Hot-melt Extruded Acrylic Matrices. Drug Dev Ind Pharm. 2010;36(2):218-26. PubMed PMID: 19877992.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aqueous film coating to reduce recrystallization of guaifenesin from hot-melt extruded acrylic matrices. AU - Bruce,Caroline D, AU - Fegely,Kurt A, AU - Rajabi-Siahboomi,Ali R, AU - McGinity,James W, PY - 2009/11/3/entrez PY - 2009/11/3/pubmed PY - 2010/3/24/medline SP - 218 EP - 26 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 36 IS - 2 N2 - OBJECTIVES: This study investigated the effect of aqueous film coating on the recrystallization of guaifenesin from acrylic, hot-melt extruded matrix tablets. METHODS: After hot-melt extrusion, matrix tablets were film-coated with either hypromellose or ethylcellulose. The effects of the coating polymer, curing and storage conditions, polymer weight gain, and core guaifenesin concentration on guaifenesin recrystallization were investigated. RESULTS: The presence of either film coating on the guaifenesin-containing tablets was found to prolong the onset time of drug crystallization. The coating polymer was the most important factor determining the delay in the onset of crystallization, with the more hydrophilic polymer, hypromellose, having a higher solubilization potential for the guaifenesin and delaying crystallization for longer period (3 or 6 months in tablets stored at 40 degrees C or 25 degrees C, respectively) than the more hydrophobic ethylcellulose, which displayed a lower solubilization potential for guaifenesin (crystal growth on tablets cured for 2 hours at 60 degrees C occurred within 3 weeks, whereas uncoated tablets displayed surface crystal growth after 30 minutes). Crystal morphology was also affected by the film coating. Elevated temperatures during both curing and storage, incomplete film coalescence, and high core drug concentrations all contributed to an earlier onset of crystal growth. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/19877992/Aqueous_film_coating_to_reduce_recrystallization_of_guaifenesin_from_hot_melt_extruded_acrylic_matrices_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639040903271277 DB - PRIME DP - Unbound Medicine ER -