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Previous issue date: 2014-04-04 / O trissoralen (Tri) ? um f?rmaco de baixa dosagem utilizado no tratamento da psor?ase e outras dermatoses. O objetivo do trabalho foi aplica??o da an?lise t?rmica e t?cnicas complementares para caracteriza??o, avalia??o da estabilidade do trissoralen e dos componentes das formula??es farmac?uticas manipuladas. O comportamento t?rmico do Tri por TG/DTG-DTA em atmosfera din?mica de ar sint?tico e nitrog?nio evidenciou o mesmo perfil com um pico de fus?o seguido de um evento relacionado ? volatiliza??o. A partir das curvas TG/DTG observou uma ?nica etapa de perda de massa. Ao aquecer o f?rmaco na estufa nas temperaturas de 80, 240 e 260 ?C observou-se que o mesmo n?o apr esentou altera??es na sua estrutura qu?mica atrav?s das t?cnicas de DRX, CLAE, MIR, MO e MEV. A partir dos estudos cin?ticos n?o-isot?rmicos e isot?rmicos por TG foi poss?vel calcular a energia de ativa??o e ordem de rea??o para o Tri. O f?rmaco apresentou uma boa estabilidade t?rmica. Estudos de compatibilidade f?rmaco-excipiente mostraram que h? intera??o do trissoralen com lauril sulfato s?dio na propor??o 1:1. N?o se observou intera??o com aerosil, amido pr?-gelatinizado, amido glicolato s?dico, celulose, croscarmelose, estearato de magn?sio, lactose e manitol. A caracteriza??o de tr?s formula??es de trissoralen nas concentra??es de 2,5; 5; 7,5; 10; 12,5 e 15 mg foi realizada por DSC, TG/DTG, DRX, MIR e NIR. Um m?todo de classifica??o PCA baseado nos dados dos espectros MIR e NIR das formula??es de trissoralen permitiu uma diferencia??o bem sucedida em tr?s grupos. A formula??o 3 foi a que melhor apresentou o perfil anal?tico com a seguinte composi??o de excipientes aerosil, amido pr?-gelatinizado e celulose. A energia de ativa??o do processo de volatiza??o do f?rmaco foi determinada nas misturas bin?rias e formula??o 3 por meio dos m?todos isoconversional e fitting. A mistura bin?ria com amido glicolato s?dico e lactose apresentaram diferen?a nos par?metros cin?ticos em compara??o ao f?rmaco isolado. As t?cnicas termoanal?ticas (DSC e TG/DTG) mostraram ser metodologias promissoras para quantifica??o do trissoralen pela linearidade obtida, seletividade, n?o uso de solventes, sem preparo de amostra, rapidez e praticidade. / The trioxsalen (Tri) is a low-dose drug used in the treatment of psoriasis and other
skin diseases. The aim of the study was applying the thermal analysis and
complementary techniques for characterization, evaluation of the trioxsalen stability
and components of manipulated pharmaceutical formulations. The thermal behavior
of the Tri by TG/DTG-DTA in dynamic atmosphere of synthetic air and nitrogen
showed the same profile with a melting peak followed by a volatilization-related
event. From the curves TG / DTG is observed a single stage of mass loss. By heating
the drug in the stove at temperatures of 80, 240 and 260 ?C, it had no change in
chemical structure through the techniques of XRD, HPLC, MIR, OM and SEM. From
the non-isothermal and isothermal TG kinetic studies was possible to calculate the
activation energy and reaction order for the Tri. The drug showed good thermal
stability. Studies on drug-excipient compatibility showed interaction of trissoralen with
sodium lauryl sulfate 1:1. There was no interaction with aerosol, pregelatinized
starch, sodium starch glycolate, cellulose, croscarmellose sodium, magnesium
stearate, lactose and mannitol.The characterization of three trioxsalen formulations at
concentrations of 2.5, 5, 7.5, 10, 12.5 and 15 mg was performed by DSC, TG / DTG,
XRD, NIR and MIR. The PCA classification method based on spectral data from the
NIR and MIR of trissoralen formulations allows successful differentiation into three
groups. The formulation 3 was the one that best showed analytical profile with the
following composition of aerosil excipients, pre-gelatinized starch and cellulose. The
activation energy of the volatilization process of the drug was determined in binary
mixtures and formulation 3 through fitting and isoconversional methods. The binary
mixture with sodium starch glycolate and lactose showed differences in kinetic
parameters compared to the drug isolated. The thermoanalytical techniques (DSC
and TG / DTG) were shown to be promising methodologies for quantifying trioxsalen
obtained by the linearity, selectivity, no use solvents, without sample preparation,
speed and practicality.
| Identifer | oai:union.ndltd.org:IBICT/oai:repositorio.ufrn.br:123456789/19353 |
| Date | 04 April 2014 |
| Creators | Lima, Naiana Gondim Pereira Barros |
| Contributors | 62001728468, http://lattes.cnpq.br/9657118649043311, Souza, F?bio Santos de, 92771300400, http://lattes.cnpq.br/4903883301058477, Moura, Maria de F?tima Vit?ria de, 31482015404, http://lattes.cnpq.br/2959800336802498, Concei??o, Marta Maria da, 80542131404, http://lattes.cnpq.br/3141068978315035, Macedo, Rui Oliveira, 16622553491, http://lattes.cnpq.br/8326594695097434, Medeiros, Ana Cl?udia Dantas de, Arag?o, C?cero Fl?vio Soares |
| Publisher | Universidade Federal do Rio Grande do Norte, PROGRAMA DE P?S-GRADUA??O EM DESENVOLVIMENTO E INOVA??O TECNOL?GICA EM MEDICAMENTOS, UFRN, Brasil |
| Source Sets | IBICT Brazilian ETDs |
| Language | Portuguese |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/doctoralThesis |
| Source | reponame:Repositório Institucional da UFRN, instname:Universidade Federal do Rio Grande do Norte, instacron:UFRN |
| Rights | info:eu-repo/semantics/openAccess |
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