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In the case of drugs which need a quick release, the use of HPMC capsules must be evaluated with caution so that less damage in the therapeutic action of the medicine be observed. Connors, K. A.; Amidon, G. L.; Stella, V. J.; ANVISA - Agncia Nacional de Vigilncia Sanitria; 13. Ampicillin anhydrous reference standard (98.35%) was obtained from Brazilian Pharmacopoeia (Brazil).

The titration was performed with volumetric solution of 0.01 M sodium thiosulfate, and starch was used as indicator solution.

This test was performed for the powder mixture formulation for the development of hard gelatin and HPMC capsules. 0000624184 00000 n 0000456290 00000 n

The quality control consists in an indispensable stage of the process for medicine manufacture, regardless of its production scale.

This equipment has round sieves for particle size analysis with 8.5 or 3 inches in diameter.

<<41A0BCFC819D394ABE199AE6BCDDB4F6>]/Prev 1243352/XRefStm 2468>>

They are considered one of the best ways to condition drug substances because they protect them from the light, air and humidity action. 0000012048 00000 n

HPMC is a cellulosic derived that is moisturized quickly, but swells and takes longer to disintegrate in body temperature; it is also more soluble in lower temperatures, such as 10 C.18,19 The gelatin is a soluble protein in hot water and in the gastric liquid, where it quickly releases its contents soluble in biological fluids at a room temperature.3 Capsules of the reference medicine showed higher values for the test compared the disintegration of gelatin capsules, probably due to compression existing in the process of industrial scale production.

This trial was conducted in triplicate following the specific method described in the Brazilian Pharmacopoeia.16 Standard solution was used at a concentration of 1.25 mg mL-1.

Furthermore, the compaction force used in the industry for the development of the reference may be delaying the drug release in dissolution medium.

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0000009212 00000 n The standard operational parameters call for a drop rate of 250 strokes per min with a drop height 3.0 mm. gelatin capsules flowchart

711 0 obj <>stream In high concentrations, the linear chains of HPMC form a tangle and result in a gelatinous layer, fairly consistent, hindering the release of the active principle.

0000535812 00000 n

These capsules were purchased from market (Genix and Capsugel, Brazil), presenting humidity values of 13.8% (GEL) and 5.8% (HPMC), according to the certificate of analysis. These results obtained are in agreement with the pharmacopoeia specifications15,16 and they show a proper process of manipulation. The determination of the granulometric strip was done mechanically using an agitator of sieves (Bertel, Brazil).

Capsules are solid pharmaceutical forms usually destined to the oral use that present a good acceptance for part of the population.1-3, The involucres used for the development of capsules are usually constituted by gelatin, water, coloring and other materials including preservatives and processing aids. , Centro Universitrio Franciscano, Brazil, Text

ampicillin; gelatin; hydroxypropyl methylcellulose, Evaluation of hard gelatin capsules and hydroxypropyl methylcellulose containing ampicillin, Graziella Gonalves Weigert; Anile Posser Ineu; Patrcia Gomes* The amount of dissolved ampicillin was determined by using a spectrophotometer UV/VIS (Shimadzu UV1650PC, Japan) and detection at a wavelength of 320 nm.

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The assay values presented that ranged from 90.06 to 114.62% for HPMC-B and GEL-B, respectively. patriciagomes0@yahoo.com.br, Curso de Farmcia, Centro Universitrio Franciscano, Rua dos Andradas, 1614, 97010-032 Santa Maria - RS, Brasil. 0000549371 00000 n 0000452329 00000 n 0000413352 00000 n 0000452612 00000 n 0000545598 00000 n The linear range comprised 2-27 g mL-1 for the dissolution profiles and 16-28 g mL-1 for the dissolution test.

0000019290 00000 n

This fact can be explained once the hydrophilic matrix, when in contact with the dissolution medium, swell and form a gelled layer that controls the subsequent entrance of water into the matrix and drug release, prolonging its release.21-23 The speed of water penetration in the matrix system determines the mode of drug release. These are important factors that must be taken into account so that the use of HPMC capsules be a viable alternative to gelatin in manipulation pharmacy and in the pharmaceutical industry for developing formulations containing ampicillin.

Bonfilio, R.; Mendona, T. F.; Pereira, G. R.; Arajo, M. B.; Tarley, C. R. T.; 18.

Recebido em 23/1/11; aceito em 1/7/11; publicado na web em 9/8/11.

Monteiro, L. M.; Souza, A. E.; Gianotto, E. A. S.; Nery, M. M. F.; Duarte, J. C.; Freitas, O.; Casagrande, R.; Baracat, M. M.; * (English), https://doi.org/10.1590/S0100-40422012000200010.

0000006776 00000 n H\@FyZv/$UV \ctc1.|9bp:)jnZlL?W8C}}>6jx:]wOpNs^f^y_G_iw{5u)bax[}/Om=>ox[8G:Uy6~f?$rl_2-&zZAP TLgByy@9. This fact can be explained because HPMC is a forming polymer of hydrophilic matrix used to promote a slower release of the drug conditioned in the capsules.20-23 The value found for the reference medicine (90.47%) resemble the values obtained for the capsules elaborated with HPMC, although this product is made from hard gelatin capsule.

0000003552 00000 n

Fortunato, K. A.; Doile, M. M; Shumcker, I. C.; Shucko, S. K.; Silva, M. A. S.; Rodrigues, P. O.; 23. 0000413267 00000 n

The dissolution medium consisted of 900 mL of distilled and degassed water, and was kept at 37 C with speed of 100 rpm. Two formulations (A and B) were developed. After the method application, calculations were performed to determine the granulometric strip of the ampicillin.5. 0000512245 00000 n 0000619171 00000 n Keywords: ampicillin; gelatin; hydroxypropyl methylcellulose.

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At very low concentrations, these cellulose gels have very low viscosity, allowing almost immediate release of drugs.21. It is soluble in hot water and in the gastric liquid, which quickly liberates its content.3, However, main Pharmacopoeias, such as the European, Japanese and American also allow the use of other appropriate materials besides gelatin. In the case of the ampicillin, whose plasmatic pick is reached in 2 h, a concern is not observed regarding the use of the HPMC capsule for this drug.

0000517285 00000 n Dissolution studies were performed according to the monograph of the pharmaceutical dosage form contained in the Brazilian Pharmacopoeia.16 Basket apparatus was used in the dissolution equipment (Pharma Test PTWS-3E, Germany). The ED% was calculated by the ratio between the area under the curve (AUC) and total area of the graph was expressed in percentage.17 The graphs were obtained by Graph PadPrism software and ED% values were compared by one-way ANOVA and accomplished by Tukey post-test. After the completion of the angle of repose, we observed that the mixing of powders and the ampicillin alone have an angle greater than 40, which characterizes a very weak flow.5 This characteristic observed for the mixture of powders destined to the production of the capsules shows that even after the addition of a small amount of excipients to the formulation A, no improvement in the flow of powders was observed. 0000007466 00000 n The final product quality was evaluated by testing for quality control and the results were in agreement with the Brazilian Pharmacopoeia. 0000007354 00000 n 0000017827 00000 n The gelatin used in capsules is justifiable because it is a nontoxic substance, widely used in food, and it is readily soluble in biological fluids at room temperature.4,5 Also, for being a protein, the gelatin is digested and absorbed. We opted for the addition of some excipients in the formulation A, since the amount of the present drug in the formulation is not always enough to make up the chosen capsule as well as due to other characteristics of the drug. 0000535062 00000 n

Ku, M. S.; Li, W.; Dulin, W.; Donahue, F.; Cade, D.; Benameur, H.; Hutchison, K.; 8. Because of the delay of the ampicillin release observed in the dissolution profiles, it becomes necessary to evaluate the drugs that can be conditioned in the HPMC capsules. ,

0000020955 00000 n For the statistical analysis of data obtained with the dissolution profiles, a comparative method was used between them and the efficiency of dissolution (ED%). The fact is relevant because the ampicillin is susceptible to hydrolysis.10,11, The analytical curves developed for the test and dissolution profiles presented a determination coefficient (R2) of 0.9969 and 0.9988, respectively. hbb2g`b``3 1x4> %PDF-1.4 %

The results of this study suggest that differences exist between the hard gelatin and HPMC involucres used in the development of capsules containing ampicillin 500 mg, mainly in relation to disintegration, and dissolution tests. 0 0000517355 00000 n The medicine reference Amplacilina (Eurofarma, Brazil) was also employed in this study.

The excipients contained in the pharmaceutical dosage form were all of pharmaceutical grades and acquired from different distributors.

0000413197 00000 n 0000011836 00000 n Aliquots were transferred to the test tube with lid, heated in water bath at 75 C for 30 min and cooled rapidly.

0000013371 00000 n 636 0 obj <> endobj Statistical analysis of the dissolution profiles. In the manipulated capsules, it could be observed that the formulation containing only the drug (formulation B) presented lower values of mean weight (579.6 and 584.88 mg for GEL-B and HPMC-B, respectively), while the capsules containing excipients (formulation A) showed higher values (624.6 mg, GEL-A and 619.72 mg, HPMC-A).

The determination of the weight of the capsules containing 500 mg of ampicillin was performed according to the Brazilian Pharmacopoeia.15 To perform this test, we used 20 capsules of each manipulated formulation (A and B) and the reference product. The granulometry found in the test for the ampicillin was superior to 600 m. The granulometric analysis of the ampicillin for the development of the capsules is an important parameter to be established; it represents a direct influence on the manipulation of the capsules in magisterial scale. The angle of repose determination was performed using the methodology proposed by Gil14 employing automated powder tester (Pharma Test PTG-2, Germany). (EN), Stay informed of issues for this journal through your RSS reader, Text 0000000016 00000 n The capsules should meet the demands of weight variation, disintegration time, assay and tenor uniformity of actives described in the monograph.12,13 Therefore, the aim of this study was to develop capsules starting from hard gelatin and HPMC involucres, to evaluate the quality of the final products and to compare them with each other and with the medicine reference.

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