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hard gelatin capsules pdf

0000017827 00000 n They are considered one of the best ways to condition drug substances because they protect them from the light, air and humidity action. Furthermore, the f2 factor indicated the similarities between the dissolution profiles of the reference medicine and GEL-A (99.95%) and GEL-B (99.86%). 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. Furthermore, the compaction force used in the industry for the development of the reference may be delaying the drug release in dissolution medium. * 0000007354 00000 n Two formulations (A and B) were developed. Six units of each formulation were subjected to dissolution test and twelve to the dissolution profile. 0000615352 00000 n To calculate the amount of ampicillin indeed dissolved in the medium, it was compared to that obtained with the ampicillin reference standard (RS) at concentration of 0.0022% (w/v) prepared under the same conditions. 0000453137 00000 n 0000008089 00000 n 0000456290 00000 n

0000517285 00000 n porcine pharmaceutical primers oligonucleotide bovine simultaneous pcr gelatin assay detection maryam beheshti shahid

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. 0000550107 00000 n 0000413352 00000 n

0000006043 00000 n This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. 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. 0000535406 00000 n %PDF-1.4 % 0000517355 00000 n endstream endobj 710 0 obj <>/Filter/FlateDecode/Index[66 570]/Length 42/Size 636/Type/XRef/W[1 1 1]>>stream patriciagomes0@yahoo.com.br, , Santa Maria, porcine pharmaceutical primers oligonucleotide bovine simultaneous pcr gelatin assay detection maryam beheshti shahid After testing, aliquots of 10 mL were removed from the dissolution medium, filtered and diluted in cuprum sulfate buffer to appropriate concentration (22 g mL-1). This fact associated with features of ampicillin, such as increased size, density, and hygroscopic end up making the manipulation difficult because of the resistance of the flow of powders in manual encapsulator and difficulty of accommodation in the same involucres. 0000535812 00000 n 0000009848 00000 n capsules empty gelatin

The titration was performed until the disappearance of the blue color. patriciagomes0@yahoo.com.br, Curso de Farmcia, Centro Universitrio Franciscano, Rua dos Andradas, 1614, 97010-032 Santa Maria - RS, Brasil. 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.

Because of the delay of the drug release in initial times of the dissolution profiles, it becomes necessary to evaluate the drugs that can be conditioned in the HPMC capsules. The reference medicine showed values of mean weight similar to the capsules with the formulation A (612.90 mg), which denotes the quality of the product elaborated in magisterial scale. 0000006739 00000 n shivang chaudhary qbd analyzing controlling gelatin feedback

<<41A0BCFC819D394ABE199AE6BCDDB4F6>]/Prev 1243352/XRefStm 2468>> There was no significant difference (P> 0.05) in the ED% from the capsules GEL-B (66.78%), GEL-A (60.97%) and the reference medicine (62.37%) as well as between HPMC-A (74.92%) and HPMC-B (76.18%). 0000549371 00000 n 2. 0000413197 00000 n The choice of hydrophilic polymer in the matrix formulation can provide an appropriate combination of the swelling mechanisms, dissolution or erosion and determine the release kinetics in vitro.21 According to previous work,22 the drug incorporation in hydrophilic matrix systems is the most used method to prolong drug release dosage forms for oral use.

636 76 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. Stability studies are necessary to evaluate the real contribution of the hard gelatin and HPMC capsules relation to the protection of drugs conditioned in these capsules. 0000624184 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. The high density found for the ampicillin (0.5557 g cm-3) provided the choice of capsule number 00 (0.95 mL). The formulations with HPMC capsules showed lower percentages of drug dissolved (99.67%, HPMC-A and 87.70%, HPMC-B) than the gelatin (100.18%, GEL-A and 101.16% GEL-B). Raj, T. J. S.; Bharati, C. H.; Ranga, K.; Raoa, K. R.; 11.

Other tested formulations showed significant differences (P <0.05, P <0.01 and P <0.001), which can be explained mainly by the difference in the nature of the involucres that directly influence the dissolution efficiency.

0000007466 00000 n 0000019631 00000 n 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. Ogura, T.; Matsuura, S.; Futuya, Y.; 6. 0000002826 00000 n The samples were diluted to concentrations similar to the pattern. 0000517248 00000 n This comparison cannot be performed with the reference medicine and HPMC capsules, because they are of different constitution. 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. 0000004983 00000 n A portion of 50 g of ampicillin for the development of the formulations was put in the sieve and submitted to sieving for 20 min. 0000012048 00000 n xref

Connors, K. A.; Amidon, G. L.; Stella, V. J.; ANVISA - Agncia Nacional de Vigilncia Sanitria; 13. 0000018887 00000 n 0000011152 00000 n The assay of the examined formulations (A and B) and the reference medicine was performed through iodometric method. The collection time for the dissolution test consisted of 45 min. The dissolution medium consisted of 900 mL of distilled and degassed water, and was kept at 37 C with speed of 100 rpm. 0000465702 00000 n This study aims to develop and evaluate formulations containing ampicillin in capsules of gelatin and hydroxypropyl methylcellulose (HPMC). 0000014498 00000 n Keywords: ampicillin; gelatin; hydroxypropyl methylcellulose. The dissolution efficiency of the five samples (reference, GEL-A, GEL-B, HPMC-A and HPMC-B) showed significant differences among groups (P> 0.05) in ANOVA. 0000002468 00000 n 0000614785 00000 n The angle of repose determination was performed using the methodology proposed by Gil14 employing automated powder tester (Pharma Test PTG-2, Germany). 0000545197 00000 n The disintegration test was carried out following the established methodology for Brazilian Pharmacopoeia15 using the disintegration tester (Pharma Test PTZ-E, Germany). crosslinking formaldehyde determination extent gelatin spectrophotometry nir spectra reconstructed 0000021782 00000 n Kamel, S.; Ali, N.; Jahangir, K.; Shah, S. M.; El-Gendy, A. These results obtained are in agreement with the pharmacopoeia specifications15,16 and they show a proper process of manipulation. Monteiro, L. M.; Souza, A. E.; Gianotto, E. A. S.; Nery, M. M. F.; Duarte, J. C.; Freitas, O.; Casagrande, R.; Baracat, M. M.; * This instrument is suitable for testing powder Flow Time, the measurement of the cone angle (angle of repose) of the collected powder mound, measuring the weight, calculating the density and the volume of the powder cone as well as the EP/USP "Flowability" results which is to measure the flow time of 100 g of sample through a specified pouring nozzle.

For the statistical analysis of data obtained with the dissolution profiles, a comparative method was used between them and the efficiency of dissolution (ED%). This may be related to the present excipients in the reference medicine (lactose, methylcellulose, stearic acid and magnesium stearate), which are different from the excipients used in the B formulation. 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. 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. 0000619569 00000 n The granulometry above 600 m found for the ampicillin trihydrate involved a complex manipulation of the drug in magisterial scale, making the accommodation of the powders in the manual encapsulator.

0000001853 00000 n Thus, the problems involving hygroscopic drugs, sensitive to the humidity and with problems in their interaction with the gelatin molecules can be circumvented.6,7, The capsules produced with HPMC involucre guarantee the hygroscopic drugs stability, such as ampicillin, a bactericidal antibiotic of wide spectrum that acts against aerobic gram-negative bacteria.8,9 In the case of ampicillin, it is possible to foresee some possible degradation reactions because the ring beta-lactam is susceptible to hydrolysis (Figure 1).10,11. 0000413267 00000 n This equipment has round sieves for particle size analysis with 8.5 or 3 inches in diameter. Four formulations were developed containing 500 mg of ampicillin in hard gelatin capsules (GEL) and HPMC capsules. Recebido em 23/1/11; aceito em 1/7/11; publicado na web em 9/8/11. The standard operational parameters call for a drop rate of 250 strokes per min with a drop height 3.0 mm. The quality control consists in an indispensable stage of the process for medicine manufacture, regardless of its production scale. hbb2g`b``3 1x4> The water determination test showed lower humidity tenors for HPMC capsules than gelatin capsules. The amount of dissolved ampicillin was determined by using a spectrophotometer UV/VIS (Shimadzu UV1650PC, Japan) and detection at a wavelength of 320 nm. 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. The final product quality was evaluated by testing for quality control and the results were in agreement with the Brazilian Pharmacopoeia. 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. , Centro Universitrio Franciscano, Brazil, Text 0000015420 00000 n 0000619171 00000 n

The titration was performed with volumetric solution of 0.01 M sodium thiosulfate, and starch was used as indicator solution. The time limit established for this test for hard gelatin, HPMC and the reference drug capsules was 45 min.15. 0000615305 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. 0000622280 00000 n 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. hb```e`X`o "l@Q6 U98=apte4Vs0^L%F}^ [&kL%:T%A JDEWSxGc^UW],;;==X{A+ $(1&%%%c @b`IA(G PPA-7 82iaK,^14` capsules empty gelatin 0000019290 00000 n 0000008943 00000 n The analytical curve was prepared from a standard solution of ampicillin RS concentration of 100 g mL-1. However, there are no literature values for this drug granulometry. The values obtained in this test demonstrate that the excipients added to the formulation A and the ones in the reference medicine did not aid in the disintegration process, when compared to the formulation containing only the ampicillin (formulation B). 0000505773 00000 n

711 0 obj <>stream 0000452612 00000 n 0000020032 00000 n The medicine reference Amplacilina (Eurofarma, Brazil) was also employed in this study. 0000534799 00000 n 0000452329 00000 n Statistical analysis of the dissolution profiles. capsule lod hypromellose indicators gelatin locked moawia The determination of the granulometric strip was done mechanically using an agitator of sieves (Bertel, Brazil).

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. 0000544877 00000 n 0 0000005418 00000 n Ampicillin anhydrous reference standard (98.35%) was obtained from Brazilian Pharmacopoeia (Brazil). 0000003552 00000 n 0000008456 00000 n Fortunato, K. A.; Doile, M. M; Shumcker, I. C.; Shucko, S. K.; Silva, M. A. S.; Rodrigues, P. O.; 23. 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. The excipients contained in the pharmaceutical dosage form were all of pharmaceutical grades and acquired from different distributors.

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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.

The ED% was calculated from the percentage curves of drug dissolved versus time. 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. Hard gelatin and HPMC involucres have different compositions therefore it is necessary to study the development of formulations involving these involucres as well as the evaluation of the final product quality.

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). trailer (EN), Stay informed of issues for this journal through your RSS reader, Text endstream endobj 637 0 obj <>/Metadata 64 0 R/PageLabels 61 0 R/Pages 63 0 R/StructTreeRoot 66 0 R/Type/Catalog/ViewerPreferences<>>> endobj 638 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/XObject<>>>/Rotate 0/StructParents 2/TrimBox[0.0 0.0 581.102 822.047]/Type/Page>> endobj 639 0 obj <> endobj 640 0 obj <> endobj 641 0 obj <> endobj 642 0 obj <> endobj 643 0 obj <> endobj 644 0 obj <> endobj 645 0 obj <>stream c`wT t :QvZ * @D:v2x7p01TamP,`dg`y1J O A'30hX60` % W 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. It was observed that with increasing amounts of HPMC in the formulations it is possible to get a reduced release of the drug, which can be evidenced in the dissolution tests.23 With the use of HPMC in capsules, this polymer characteristic may promote a release different from the one observed with the capsules produced with gelatin, delaying the release of the drug and consequently modifying its kinetics of release.

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hard gelatin capsules pdf