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Thermal behavior and stability of biodegradable spray-dried microparticles containing triamcinolone.
Int J Pharm. 2009 Feb 23; 368(1-2):45-55.IJ

Abstract

Thermal analysis has been widely used for obtaining information about drug-polymer interactions and for pre-formulation studies of pharmaceutical dosage forms. In this work, biodegradable microparticles of poly (d,L-lactide-co-glycolide) (PLGA) containing triamcinolone (TR) in various drug:polymer ratios were produced by spray drying. The main purpose of this study was to study the effect of the spray-drying process not only on the drug-polymer interactions but also on the stability of microparticles using differential scanning calorimetry (DSC), thermogravimetry (TG) and derivative thermogravimetry (DTG), X-ray analysis (XRD), and infrared spectroscopy (IR). The evaluation of drug-polymer interactions and the pre-formulation studies were assessed using the DSC, TG and DTG, and IR. The quantitative analysis of drugs entrapped in PLGA microparticles was performed by the HPLC method. The results showed high levels of drug-loading efficiency for all used drug:polymer ratio, and the polymorph used for preparing the microparticles was the form B. The DSC and TG/DTG profiles for drug-loaded microparticles were very similar to those for the physical mixtures of the components. Therefore, a correlation between drug content and the structural and thermal properties of drug-loaded PLGA microparticles was established. These data indicate that the spray-drying technique does not affect the physico-chemical stability of the microparticle components. These results are in agreement with the IR analysis demonstrating that no significant chemical interaction occurs between TR and PLGA in both physical mixtures and microparticles. The results of the X-ray analysis are in agreement with the thermal analysis data showing that the amorphous form of TR prevails over a small fraction of crystalline phase of the drug also present in the TR-loaded microparticles. From the pre-formulation studies, we have found that the spray-drying methodology is an efficient process for obtaining TR-loaded PLGA microparticles.

Authors+Show Affiliations

Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas, Unesp, Araraquara, São Paulo, Brazil.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18992313

Citation

da Silva, Arnóbio Antônio, et al. "Thermal Behavior and Stability of Biodegradable Spray-dried Microparticles Containing Triamcinolone." International Journal of Pharmaceutics, vol. 368, no. 1-2, 2009, pp. 45-55.
da Silva AA, de Matos JR, Formariz TP, et al. Thermal behavior and stability of biodegradable spray-dried microparticles containing triamcinolone. Int J Pharm. 2009;368(1-2):45-55.
da Silva, A. A., de Matos, J. R., Formariz, T. P., Rossanezi, G., Scarpa, M. V., do Egito, E. S., & de Oliveira, A. G. (2009). Thermal behavior and stability of biodegradable spray-dried microparticles containing triamcinolone. International Journal of Pharmaceutics, 368(1-2), 45-55. https://doi.org/10.1016/j.ijpharm.2008.09.054
da Silva AA, et al. Thermal Behavior and Stability of Biodegradable Spray-dried Microparticles Containing Triamcinolone. Int J Pharm. 2009 Feb 23;368(1-2):45-55. PubMed PMID: 18992313.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Thermal behavior and stability of biodegradable spray-dried microparticles containing triamcinolone. AU - da Silva,Arnóbio Antônio,Jr AU - de Matos,Jivaldo Rosário, AU - Formariz,Thalita Pedroni, AU - Rossanezi,Gustavo, AU - Scarpa,Maria Virginia, AU - do Egito,Eryvaldo Sócrates Tabosa, AU - de Oliveira,Anselmo Gomes, Y1 - 2008/10/15/ PY - 2008/03/04/received PY - 2008/09/26/revised PY - 2008/09/30/accepted PY - 2008/11/11/pubmed PY - 2009/7/16/medline PY - 2008/11/11/entrez SP - 45 EP - 55 JF - International journal of pharmaceutics JO - Int J Pharm VL - 368 IS - 1-2 N2 - Thermal analysis has been widely used for obtaining information about drug-polymer interactions and for pre-formulation studies of pharmaceutical dosage forms. In this work, biodegradable microparticles of poly (d,L-lactide-co-glycolide) (PLGA) containing triamcinolone (TR) in various drug:polymer ratios were produced by spray drying. The main purpose of this study was to study the effect of the spray-drying process not only on the drug-polymer interactions but also on the stability of microparticles using differential scanning calorimetry (DSC), thermogravimetry (TG) and derivative thermogravimetry (DTG), X-ray analysis (XRD), and infrared spectroscopy (IR). The evaluation of drug-polymer interactions and the pre-formulation studies were assessed using the DSC, TG and DTG, and IR. The quantitative analysis of drugs entrapped in PLGA microparticles was performed by the HPLC method. The results showed high levels of drug-loading efficiency for all used drug:polymer ratio, and the polymorph used for preparing the microparticles was the form B. The DSC and TG/DTG profiles for drug-loaded microparticles were very similar to those for the physical mixtures of the components. Therefore, a correlation between drug content and the structural and thermal properties of drug-loaded PLGA microparticles was established. These data indicate that the spray-drying technique does not affect the physico-chemical stability of the microparticle components. These results are in agreement with the IR analysis demonstrating that no significant chemical interaction occurs between TR and PLGA in both physical mixtures and microparticles. The results of the X-ray analysis are in agreement with the thermal analysis data showing that the amorphous form of TR prevails over a small fraction of crystalline phase of the drug also present in the TR-loaded microparticles. From the pre-formulation studies, we have found that the spray-drying methodology is an efficient process for obtaining TR-loaded PLGA microparticles. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/18992313/Thermal_behavior_and_stability_of_biodegradable_spray_dried_microparticles_containing_triamcinolone_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(08)00688-1 DB - PRIME DP - Unbound Medicine ER -