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Bioequivalence assay between orally disintegrating and conventional tablet formulations in healthy volunteers

ARMANDO, Yara Popst; SCHRAMM, Simone Grigoleto; SILVA, Marina de Freitas; KANO, Eunice Kazue; KOONO, Eunice Emiko Mori; PORTA, Valentina; SERRA, Cristina Helena dos Reis
Fonte: ELSEVIER SCIENCE BV Publicador: ELSEVIER SCIENCE BV
Tipo: Artigo de Revista Científica
ENG
Relevância na Pesquisa
508.82246%
The purpose of this study was to evaluate bioequivalence of two commercial 8 mg tablet formulations of ondansetrona available ill the Brazilian market. In this study, a simple, rapid, sensitive and selective liquid chromarography-tandem mass spectrometry method is described for the determination of ondansetron in human plasma samples. The method was validated over a concentration range of 2.5-60 ng/ml and used in a bioequivalence trial between orally disintegrating and conventional tablet ondansetron formulations, to assess its usefulness in this kind of Study. Vonau flash (R) (Biolab Sanus Farmaceutica, Brazil, as test formulations) and Zofran (R) (GlaxoSmithKline, Brazil, as reference formulation) were evaluated following a single 8 mg close to 23 healthy volunteers of both genders. The dose was administered after an overnight fast according to a two-way crossover design. Bioequivalence between the products was determinated by Calculating 90% confidence interval (90% CI) for the ratio of C(max), AUC(0-t) and AUC(0-(sic)) values for the test and reference products, using logarithmically transformed data. The 90% confidence interval for the ratio of C(max) (87.5-103.8%), AUC(0-t) (89.3-107.2%) and AUC(0--(sic)) (89.7-106.0%) values for the test and reference products is Within the 80-125% interval...

Bioequivalence Evaluation of Two Different Tablet Formulations of Tinidazole in Healthy Volunteers

KOONO, Eunice Emiko Mori; KANO, Eunice Kazue; SCHRAMM, Simone Grigoleto; SERRA, Cristina Helena dos Reis; PORTA, Valentina
Fonte: ECV-EDITIO CANTOR VERLAG MEDIZIN NATURWISSENSCHAFTEN Publicador: ECV-EDITIO CANTOR VERLAG MEDIZIN NATURWISSENSCHAFTEN
Tipo: Artigo de Revista Científica
ENG
Relevância na Pesquisa
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The bioequivalence of two different tablet formulations of tirtidazole (CAS 19387-91-8) was determined in healthy volunteers after a single dose in a randomized crossover study, with a 1-week washout period between the doses. Reference and test products were administered to 24 volunteers with 240 mL water after overnight fasting. Plasma concentrations of tinidazole were monitored by a high-performance liquid chromatographic method (HPLC) over a period of 72 h after the administration. The pharmacokinetic parameters AUC(0-t), AUC(0-infinity), C(max), T(max), T((1/2)el) and beta were determined from plasma concentration time profile of both formulations and found to be in good agreement with previously reported values. The calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two brands. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals for the ratio of C(max) (93.9 - 102.6%), AUC(0-t), (94.9-101.1%) and AUC(0-infinity) (94.6-100.8%) values for the test and reference products were within the 80 - 125% interval, satisfying bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. These results indicate that the test and the reference products of tinidazole are bioequivalent and...

Correlação in vitro in vivo para formas farmacêuticas sólidas de liberação modificada contendo diclofenaco de sódio; In vitro-in vivo correlation for sodium diclofenac modified release tablet formulations

Mourão, Samanta Cardozo
Fonte: Biblioteca Digitais de Teses e Dissertações da USP Publicador: Biblioteca Digitais de Teses e Dissertações da USP
Tipo: Tese de Doutorado Formato: application/pdf
Publicado em 17/09/2009 PT
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499.26812%
A correlação in vitro-in vivo (CIVIV) refere-se ao estabelecimento de uma relação racional entre as propriedades biológicas, ou parâmetros derivados destas, produzidos por uma forma farmacêutica e suas propriedades ou características físico-químicas. O estabelecimento desse tipo de correlação de dados pode possibilitar a substituição dos estudos in vivo, necessários à demonstração da bioequivalência, pelos estudos in vitro, no caso de alterações no processo de fabricação pós-registro. Os sistemas matriciais apresentam, como principal exemplo de material controlador da liberação, substâncias poliméricas formadoras de matrizes hidrofílicas. Hidroxipropilmetilcelulose (HPMC) é um excipiente de escolha para o preparo de matrizes hidrofílicas, devido à capacidade de formação de gel e controle da liberação. O diclofenaco de sódio (DCL) é um antiinflamatório não esteroidal com ação analgésica e antipirética. Considerando suas características físico-químicas e farmacológicas, é objetivo deste trabalho o estabelecimento de uma CIVIV para DCL incorporado em sistemas matriciais. Os comprimidos de DCL com HPMC foram desenvolvidos e submetidos aos ensaios de dissolução utilizando os aparatos 1...

Influence of binder type and process parameters on the compression properties and microbial survival in diclofenac tablet formulations

Ayorinde,John Oluwasogo; Itiola,Oludele Adelanwa; Odeku,Oluwatoyin Adepeju; Odeniyi,Michael Ayodele
Fonte: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/12/2011 EN
Relevância na Pesquisa
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The influence of binder type and process parameters on the compression properties and microbial survival in diclofenac tablet formulations were studied using a novel gum from Albizia zygia. Tablets were produced from diclofenac formulations containing corn starch, lactose and dicalcium phosphate. Formulations were analyzed using the Heckel and Kawakita plots. Determination of microbial viability in the formulations was done on the compressed tablets of both contaminated and uncontaminated tablets prepared from formulations. Direct compression imparted a higher plasticity on the materials than the wet granulation method. Tablets produced by wet granulation presented with a higher crushing strength than those produced by the direct compression method. Significantly higher microbial survival (p< 0.05) was obtained in formulations prepared by direct compression. The percent survival of Bacillus subtilis spores decreased with increase in binder concentration. The study showed that Albizia gum is capable of imparting higher plasticity on materials and exhibited a higher reduction of microbial contaminant in the formulations. The direct compression method produced tablets of reduced viability of microbial contaminant.

Developing methods to compare tablet formulations of atorvastatin

Oliveira,Marcelo Antonio de; Lacerda,Caroline Dutra; Bonella,André Fazôlo
Fonte: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/12/2012 EN
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485.55223%
Atorvastatin (ATV) is an antilipemic drug of great interest to the pharmaceutical industry. ATV does not appear in the monographs of Brazilian pharmacopoeia, and analytical methodologies for its determination have been validated. The chromatographic conditions used included: RP-18 column-octadecylsilane (250 x 4.6 mm, 5 mm), detection at 238 nm, mobile phase containing 0.1% phosphoric acid and acetonitrile (35:65% v/v), flow at 1.5 mL min-1, oven temperature at 30ºC, and injection volume of 10 mL. ATV is classified as a class II product, according to the biopharmaceutical classification system. As such, a dissolution test was proposed to evaluate pharmaceutical formulations on the market today, under the following conditions: water as a dissolution medium, 1000 mL as a volume, paddle apparatus at a rotation speed of 50 rpm, 80% (Q) in 15 minutes with UV spectrophotometer readings at 238 nm. In the pattern condition proposed as the ideal dissolution test, which appropriately differentiates amongst formulations, the generic product was not considered pharmaceutically equivalent; however, in other less differential dissolution methods, which also fall within appropriate legal parameters, this product could come to be regarded as generic.

Bioavailability of syrup and tablet formulations of cefetamet pivoxil.

Ducharme, M P; Edwards, D J; McNamara, P J; Stoeckel, K
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /12/1993 EN
Relevância na Pesquisa
518.94742%
Two studies examining the bioavailability of cefetamet pivoxil in healthy male subjects were conducted. In the first, the bioavailabilities of the 250-mg (M250) and M500 tablet formulations of cefetamet pivoxil to be marketed were compared with that of a tablet used in clinical trials. All products were given with food at a dose of 500 mg. In the second study, the bioavailability of the syrup formulation was evaluated under both fasting and nonfasting conditions and compared with that of the M500 tablet formulation given with food. The absolute bioavailabilities of the M500 and M250 tablets (55.0% +/- 8.0% and 55.7% +/- 7.0%, respectively) were not significantly different from that of the clinical-trial formulation (49.8% +/- 8.5%). The newer tablet formulations exhibited faster absorption as evidenced by higher peak concentrations (3.8 [M500] and 3.9 [M250] mg/liter compared with 3.2 mg/liter for the clinical-trial formulation), a shorter time to peak concentration, and a shorter mean absorption time. The syrup formulation was found to have significantly lower absolute bioavailability (37.9% +/- 6.0%) compared with that of the M500 tablet (58.4% +/- 9.0%) when both were given with food. Food had no significant effect on the bioavailability of the syrup...

Comparative Bioavailability of Sulindac in Capsule and Tablet Formulations

Reid, Joel M.; Mandrekar, Sumithra J.; Carlson, Elsa C.; Harmsen, W. Scott; Green, Erin M.; McGovern, Renee M.; Szabo, Eva; Ames, Matthew M.; Boring, Daniel; Limburg, Paul J.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /03/2008 EN
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510.87387%
The cyclooxygenase-2 (COX-2) enzyme appears to be an important target for cancer chemoprevention. Given the recent emergence of potentially serious cardiovascular toxicity associated with selective COX-2 inhibitors, nonsteroidal antiinflammatory drugs (NSAIDs), which inhibit both COX-1 and COX-2, have received renewed attention as candidate chemoprevention agents. Sulindac has demonstrated consistent chemopreventive potential in preclinical studies, as well as in a limited number of clinical trials reported to date. For the current pharmacokinetic study, sulindac capsules were prepared to facilitate ample agent supplies for future intervention studies. Encapsulation of the parent compound (sulindac sulfoxide) can be readily accomplished, but the effects of alternate formulations on bioavailability have not been rigorously examined. In the present single-dose, two-period crossover trial, we conducted pharmacokinetic analyses of sulindac in capsule (test) versus tablet (reference) formulations. Overall, bioavailability appeared to be higher for the capsule compared to the tablet formulation, based on test-to-reference pharmacokinetic parameter ratios for the parent compound. However, additional analyses based on the sulfide and sulfone metabolites of sulindac with the same pharmacokinetic parameters indicated similar chemopreventive exposures between the capsule and tablet formulations. These data support the use of sulindac capsules...

Controlled Release Hydrophilic Matrix Tablet Formulations of Isoniazid: Design and In Vitro Studies

Hiremath, Praveen S.; Saha, Ranendra N.
Fonte: Springer US Publicador: Springer US
Tipo: Artigo de Revista Científica
Publicado em 19/11/2008 EN
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503.3495%
The aim of the present investigation was to develop oral controlled release matrix tablet formulations of isoniazid using hydroxypropyl methylcellulose (HPMC) as a hydrophilic release retardant polymer and to study the influence of various formulation factors like proportion of the polymer, polymer viscosity grade, compression force, and release media on the in vitro release characteristics of the drug. The formulations were developed using wet granulation technology. The in vitro release studies were performed using US Pharmacopoeia type 1 apparatus (basket method) in 900 ml of pH 7.4 phosphate buffer at 100 rpm. The release kinetics was analyzed using Korsmeyer–Peppas model. The release profiles were also analyzed using statistical method (one-way analysis of variance) and f2 metric values. The release profiles found to follow Higuchi’s square root kinetics model irrespective of the polymer ratio and the viscosity grade used. The results in the present investigation confirm that the release rate of the drug from the HPMC matrices is highly influenced by the drug/HPMC ratio and viscosity grade of the HPMC. Also, the effect of compression force and release media was found to be significant on the release profiles of isoniazid from HPMC matrix tablets. The release mechanism was found to be anomalous non-Fickian diffusion in all the cases. In the present investigation...

Influence of Formulation Factors on Tablet Formulations with Liquid Permeation Enhancer Using Factorial Design

Bejugam, Naveen K.; Parish, Helen J.; Shankar, Gita N.
Fonte: Springer US Publicador: Springer US
Tipo: Artigo de Revista Científica
Publicado em 01/12/2009 EN
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524.0578%
For a drug with low bioavailability, a matrix tablet with liquid permeation enhancer (Labrasol®) was formulated. Factorial design was used to evaluate the effect of three formulation factors: drug percentage, polymer type (Methocel® K100M or Eudragit® L 100-55), and tablet binder percentage (Plasdone® S-630) on tablet characteristics. Tablets were prepared by direct compression and characterized. Compressibility index values ranged between 15.90% and 29.87% and tablet hardness values from 7.8 to 29.78 Kp. Eudragit®-containing formulations had better compressibility index values with higher tablet hardness. Time for 75% of drug release (T75) was calculated, and formulations containing Eudragit® L 100-55 had faster release rates than tablet formulations with Methocel® K100M. Formulations with Methocel® K100M fit well in the Higuchi model as indicated by their R2 values (>0.98). Among all the formulation factors studied, polymer type displayed the highest and statistically significant effect on compressibility index, tablet hardness, and dissolution rate. Statistical design helped in better understanding the effect of formulation factors on tablet characteristics important for designing formulations with desired characteristics.

A Design and Evaluation of Layered Matrix Tablet Formulations of Metoprolol Tartrate

Baloğlu, Esra; Şenyiğit, Taner
Fonte: Springer US Publicador: Springer US
Tipo: Artigo de Revista Científica
Publicado em 30/03/2010 EN
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516.23875%
The aim of this paper was to evaluate the performance of different swellable polymers in the form of layered matrix tablets to provide controlled therapeutic effect of metoprolol tartrate for twice daily administration. Seven different swellable polymers (carrageenan, hydroxypropylmethyl cellulose, pectin, guar gum, xanthan gum, chitosan, and ethyl cellulose) were evaluated alone or in combination as release-retardant layer. Tablets were tested for weight variation, hardness, diameter/thickness ratio, friability, and drug content uniformity and subjected to in vitro drug-release studies. In addition, the target-release profile of metoprolol tartrate was plotted using its clinical pharmacokinetic data, and the release profiles of the tablets were evaluated in relation to the plotted target release profile. Carrageenan was determined as the best polymer in two-layered matrix tablet formulations due to its better accordance to the target release profile and was selected for preparing three-layered matrix tablets. Carrageenan formulations exhibited super case II release mechanism. Accelerated stability testing was performed on two- and three-layered matrix tablet formulations of carrageenan. The tablets were stored at 25°C/60% relative humidity and 40°C/75% relative humidity for 6 months and examined for physical appearance...

Zero Order Spectrophotometric Method for Estimation of Escitalopram Oxalate in Tablet Formulations

Sharma, S; Rajpurohit, H; Sonwal, C; Bhandari, A; Choudhary, VR; Jain, T
Fonte: Medknow Publications Publicador: Medknow Publications
Tipo: Artigo de Revista Científica
Publicado em //2010 EN
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497.26953%
A new, simple, fast and reliable zero order spectrophotometric method has been developed for determination of Escitalopram Oxalate in bulk and tablet dosage forms. The quantitative determination of drug was carried out using the zero order values (absorbance) measured at 238 nm. Calibration graph constructed at 238 nm was linear in concentration range of 2-20 µg/ml with correlation coefficient 0.9999. The method was found to be precise, accurate, specific, and validated as per ICH guidelines and can be used for determination of Escitalopram Oxalate in tablet formulations.

A comparison of preference for and efficacy of tablet formulations of sumatriptan (50 mg and 100 mg), naratriptan (2.5 mg), rizatriptan (10 mg), and zolmitriptan (2.5 mg) in the acute treatment of migraine

Dahlöf, Carl; Jones, Martin; Davis, Kim; Loftus, Jane; Salonen, Reijo
Fonte: Springer-Verlag Publicador: Springer-Verlag
Tipo: Artigo de Revista Científica
Publicado em /08/2004 EN
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490.085%
This randomized, multicenter, open-label, five-way crossover study was conducted to assess patients’ preference for tablet formulations of sumatriptan (50 mg and 100 mg), naratriptan (2.5 mg), rizatriptan (10 mg), and zolmitriptan (2.5 mg) in the acute treatment of migraine and to identify determinants of preference. Patients treated one mild, moderate, or severe migraine with each triptan. The results show that sumatriptan 100 mg was significantly preferred over the random preference rate of 20% (p<0.001) whereas sumatriptan 50 mg, naratriptan, rizatriptan, and zolmitriptan were not. Patients’ primary reason for preferring a medication was best relief of migraine pain, and the treatment that patients preferred corresponded to the medication that was most likely to confer for them a pain-free response 2 hours postdose. Across all patients, efficacy 2 hours postdose was comparable among triptans with the exception of naratriptan, which was slightly less effective than the other medications (pain-free response 2 hours postdose: 40% sumatriptan 100 mg, 37% sumatriptan 50 mg, 28% naratriptan 2.5 mg, 38% rizatriptan 10 mg, 36% zolmitriptan 2.5 mg). The medications were also similarly well-tolerated. These data demonstrate that information on patients’ medication preference supplements and does not duplicate data from traditional efficacy measures. Patient preference data are useful in tailoring migraine therapy to the needs of the individual patient.

Comparison of Dissolution Profiles and Serum Concentrations of Two Lamotrigine Tablet Formulations

Lalic, Mladena; Pilipovic, Ana; Golocorbin-Kon, Svetlana; Gebauer-Bukurov, Ksenija; Bozic, Ksenija; Mikov, Momir; Cvejic, Jelena
Fonte: Springer International Publishing Publicador: Springer International Publishing
Tipo: Artigo de Revista Científica
EN
Relevância na Pesquisa
495.7698%
Objective: The aim of this study was to investigate the extent of variations in lamotrigine serum concentrations between two immediate-release tablet formulations. Data were compared with in vitro difference and similarity tests on dissolution profiles of the two formulations.

Normal-phase LC method for simultaneous analysis of pseudophedrine hydrochloride, dextromethorphan hydrobromide, chlorpheniramine maleate, and paracetamol in tablet formulations

Al-Rimawi, Fuad
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
EN
Relevância na Pesquisa
490.085%
A simple, precise, and accurate method is developed and validated for the analysis of pseudophedrine hydrochloride, dextromethorphan hydrobromide, chlorpheniramine maleate, and paracetamol in tablet formulations. The method has shown adequate separation of the four ingredients from each other. Separation was achieved on a silica column (5 μm, 125 × 4.6 mm inner diameter) using a mobile phase consisting of methanol/ammonium dihydrogen phosphate buffer (90:10, v/v) at a flow rate of 1.0 ml/min and UV detection at 220 nm. This new method is validated in accordance with USP requirements for new methods for assay determination, which include accuracy, precision, selectivity, linearity and range, robustness and ruggedness. The current method demonstrates good linearity over the range of 0.15–0.45 mg/ml of pseudophedrine hydrochloride with r2 of 0.996, and in the range of 0.075–0.225 mg/ml of dextromethorphan hydrobromide with r2 of 0.992, and in the range of 0.01–0.03 mg/ml of chlorpheniramine maleate with r2 of 0.994, and in the range of 0.25–0.75 mg/ml of paracetamol with r2 of 0.991. The average recovery of the method is 99.7%, 98.6%, 98.1%, and 99.2% for pseudophedrine hydrochloride, dextromethorphan hydrobromide...

Evaluation of starches obtained from four Dioscorea species as binding agent in chloroquine phosphate tablet formulations

Okunlola, Adenike; Odeku, Oluwatoyin A.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
EN
Relevância na Pesquisa
506.45266%
Starches obtained from four Dioscorea species namely Dioscorea dumetorum (Bitter), Dioscorea oppositifolia (Chinese), Dioscorea alata (Water), and Dioscorea rotundata (White) have been evaluated as binding agents in chloroquine phosphate tablet formulations in comparison with official corn starch. The compressional properties of the formulations were analyzed using density measurements and the Heckel and Kawakita equations. The mechanical properties of the tablets were assessed using tensile strength, brittle fracture index (BFI), and friability tests while the drug release properties of the tablets were assessed using disintegration and dissolution times. The results indicate that the four starches vary considerably in their physicochemical properties. The ranking for the tensile strength and the disintegration and dissolution times for the formulations was Chinese > Bitter > Corn > White > Water while the ranking was reversed for BFI and friability. The results suggest that Water, White, and Corn could be useful when faster disintegration time of tablets is desired while Chinese and Bitter could be more useful when bond strength is of concern and in minimizing the problems of lamination and capping in tablet formulation.

Development and Validation of Weight, Height and Age Bands to Guide the Prescription of Fixed-Dose Dispersible Tablet Formulations

Larson, Charles P.; Sauvé, Laura; Senkungu, Jude Kimbowa; Arifeen, Shams El; Brant, Rollin
Fonte: Pediatric Pharmacy Advocacy Group Publicador: Pediatric Pharmacy Advocacy Group
Tipo: Artigo de Revista Científica
Publicado em //2015 EN
Relevância na Pesquisa
490.085%
OBJECTIVES: Conversion of pediatric essential drugs from syrup to dispersible tablet formulations would require fixed dose options guided by the weight band in which a child falls or a proxy for weight, such as height or age. The purpose of this study was to determine whether weight, height, or age bands can be created that would lead to greater than 95% of children receiving a therapeutic dose of 6 commonly prescribed essential drugs, including paracetamol, iron sulfate, amoxicillin, co-trimoxazole (i.e., trimethoprim/sulfamethoxazole), ciprofloxacin, and co-artemether (i.e., artemether/lumefantrine).

Evaluation of Cedrela gum as a binder and bioadhesive component in ibuprofen tablet formulations

Odeniyi,Michael Ayodele; Babalola,Adepeju Oluwadamilare; Ayorinde,John Oluwasogo
Fonte: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/03/2013 EN
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716.2494%
The compressional, mechanical and bioadhesive properties of tablet formulations incorporating a new gum obtained from the incised trunk of the Cedrela odorata tree were evaluated and compared with those containing hydroxypropylmethylcellulose (HPMC). Compressional properties were evaluated using Hausner's ratio, Carr's Index, the angle of repose, and Heckel, Kawakita and Gurnham plots. Ibuprofen tablets were prepared using the wet granulation method. Bioadhesive studies were carried out using the rotating cylinder method in either phosphate buffer pH 6.8 or 0.1 M hydrochloric acid media. The gum is a low viscosity polymer (48 cPs), and Fourier transform infrared spectroscopy revealed the presence of a hydroxyl group. Py and Pk values, which are measures of plasticity, showed the gum to be significantly (p<0.05) more plastic than HPMC, and plasticity increased with polymer concentration. All tablet formulations were non-friable (<1.0%), and the formulations containing the gum had a higher crushing strength (130.95 N) than those containing HPMC (117.85 N) at 2.0% w/w binder. Formulations incorporating the gum were non-disintegrating and had a significantly longer drug release time than those containing HPMC. At the highest binder concentration...

Dissolution efficiency and bioequivalence study using urine data from healthy volunteers: a comparison between two tablet formulations of cephalexin

Serra, Cristina Helena dos Reis; Chang, Kyung Hee; Dezani, Thaisa Marinho; Porta, Valentina; Storpirtis, Sílvia
Fonte: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
Tipo: info:eu-repo/semantics/article; info:eu-repo/semantics/publishedVersion; ; ; ; ; ; Formato: application/pdf
Publicado em 01/06/2015 ENG
Relevância na Pesquisa
506.45266%
;The aim of the present study was to assess the bioequivalence of two cephalexin tablet formulations available in the Brazilian market (product A as reference formulation and product B as test formulation). Dissolution efficiency (DE%) was calculated for both formulations to evaluate their;in vitro;biopharmaceutical features. The oral bioequivalence study was performed in twenty-four healthy volunteers in a crossover design. Single oral dose (tablet containing 500 mg of cephalexin) of each product was administered with two weeks of washout period. Urinary concentrations of cephalexin were measured by high-performance liquid chromatography (HPLC) method and pharmacokinetics parameters were estimated by urinary excretion data. The bioequivalence was determined by the following parameters: the cumulative amount of cephalexin excreted in the urine, the total amount of cephalexin excreted in the urine and the maximum urinary excretion rate of cephalexin. DE values of immediate-release cephalexin tablets (500 mg) were 68.69±4.18% for product A and 71.03±6.63% for product B. Regarding the dissolution test of the two brands (A and B) analysed, both were in compliance with the official pharmacopeial specifications, since the dissolution of both formulations was superior to 80% of the amount declared in the label after 45 minutes of test (A=92.09%±1.84; B=92.84%±1.08). The results obtained indicated that the products A and B are pharmaceutical equivalents. Confidence intervals for the pharmacokinetic parameters were in compliance with the international standards...

Evaluation of Cedrela gum as a binder and bioadhesive component in ibuprofen tablet formulations

Odeniyi, Michael Ayodele; Babalola, Adepeju Oluwadamilare; Ayorinde, John Oluwasogo
Fonte: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
Tipo: info:eu-repo/semantics/article; info:eu-repo/semantics/publishedVersion; ; ; ; ; ; Formato: application/pdf
Publicado em 01/03/2013 ENG
Relevância na Pesquisa
702.9543%
Propriedades de compressão, mecânicas e de formulações de comprimidos bioadesivos, que incorporam nova goma de mascar obtidas a partir de incisão de tronco da árvore de Cedrela odorata, foram avaliadas e comparadas com aquelas contendo hidroxipropilmetilcelulose (HPMC). Propriedades de compressão foram avaliadas usando a razão de Hausner, índice de Carr, ângulo de repouso e os gráficos de Heckel, Kawakita e Gurnham. Prepararam-se comprimidos de ibuprofeno utilizando o método de granulação a úmido. Realizaram-se estudos de bioadesividade utilizando o método de cilindro rotativo em tampão fosfato pH 6,8, ou meio ácido com 0,1 M de ácido clorídrico. A goma é um polímero de baixa viscosidade (48 cPs) e a espectroscopia no infravermelho por Transformada de Fourier (FTIR) revelou a presença de um grupo hidroxila. Valores de Py e Pk, que são medidas de plasticidade, mostraram que a goma é significativamente (p; The compressional, mechanical and bioadhesive properties of tablet formulations incorporating a new gum obtained from the incised trunk of the Cedrela odorata tree were evaluated and compared with those containing hydroxypropylmethylcellulose (HPMC). Compressional properties were evaluated using Hausner's ratio...

Influence of binder type and process parameters on the compression properties and microbial survival in diclofenac tablet formulations

Ayorinde, John Oluwasogo; Itiola, Oludele Adelanwa; Odeku, Oluwatoyin Adepeju; Odeniyi, Michael Ayodele
Fonte: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
Tipo: info:eu-repo/semantics/article; info:eu-repo/semantics/publishedVersion; ; ; ; ; ; Formato: application/pdf
Publicado em 01/12/2011 ENG
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505.65637%
A influência do tipo de ligante e os parâmetros do processo de propriedades de compressão e sobrevivência microbiana em comprimidos de diclofenaco foram estudados utilizando uma nova goma de Albizia zygia. Os comprimidos foram produzidos a partir de formulações de diclofenaco contendo amido de milho, lactose e fosfato bicálcico. As formulações foram analisadas usando os gráficos de Heckel e Kawakita. A determinação da viabilidade microbiana nas formulações foi feita nos comprimidos contaminados e não contaminados preparados a partir de formulações. A compressão direta confere maior plasticidade dos materiais do que o método de granulação úmida. Comprimidos produzidos por granulação úmida apresentaram maior força de esmagamento do que aqueles produzidos pelo método de compressão direta. Observou-se sobrevivência significativamente maior (p; The influence of binder type and process parameters on the compression properties and microbial survival in diclofenac tablet formulations were studied using a novel gum from Albizia zygia. Tablets were produced from diclofenac formulations containing corn starch, lactose and dicalcium phosphate. Formulations were analyzed using the Heckel and Kawakita plots. Determination of microbial viability in the formulations was done on the compressed tablets of both contaminated and uncontaminated tablets prepared from formulations. Direct compression imparted a higher plasticity on the materials than the wet granulation method. Tablets produced by wet granulation presented with a higher crushing strength than those produced by the direct compression method. Significantly higher microbial survival (p< 0.05) was obtained in formulations prepared by direct compression. The percent survival of Bacillus subtilis spores decreased with increase in binder concentration. The study showed that Albizia gum is capable of imparting higher plasticity on materials and exhibited a higher reduction of microbial contaminant in the formulations. The direct compression method produced tablets of reduced viability of microbial contaminant.