Ciprofloxacin Hydrochloride Tablets Research Articles

Preparation and evaluation of ciprofloxacin solid dispersion tablets developed from stearic acid, Polyethylene Glycol 4000 and Soluplus

Ciprofloxacin is a fluoroquinolone antibiotic with a broad spectrum of activity used for the treatment of various bacterial infections and is characterized by poor aqueous solubility and low permeability. The aim of this study is to formulate and characterize ciprofloxacin solid dispersions using hydrophilic and lipophilic matrices for improved product qualities and drug delivery. Ciprofloxacin hydrochloride tablets were formulated as solid dispersions by melting and solvent evaporation in tablet moulds using varying concentrations of stearic acid (10-40 %w/w), Polyethylene glycol 4000 (PEG 4000) (10-40 %w/w) and Soluplus® (10-20 %w/w as ethanolic solution) as components. The prepared tablets were evaluated for weight uniformity, friability, hardness, Fourier transform-infrared spectroscopy (FT-IR), moisture uptake, swelling index, disintegration time and dissolution rate, using standard methods and optimization techniques. The results showed uniform solid dispersion weights with friability, hardness, moisture uptake and swelling index of 0.4-0.5%, 3.0-7.5 kgf, mostly <20% and 1-71%, respectively. The formulations were chemically stable with no transformational interactions between components. Formulations without stearic acid disintegrated within 30 min whereas those containing the lipid broke up after more than 1 h. Drug release studies showed high immediate release in tablets without stearic acid but with cumulative steady state release higher in formulations with 10 %w/w Soluplus and different concentrations of stearic acid and PEG 4000. In conclusion, ciprofloxacin was presented as solid dispersion tablets with modified physicochemical attributes for improved drug delivery.
 Keywords: Ciprofloxacin; solid dispersion; drug delivery

Pharmacokinetics and bioequivalence study oftwo ciprofloxacin hydrochloride tablets in healthy Chinese subjects under fasting and fed conditions: A randomized, open-label, two-formulation, two-sequence, two-period, single-dose crossover study.

The study mainly aimed to determine the bioequivalence of two branded ciprofloxacin hydrochloride tablets (250 mg) under fasting and fed conditions. The study was carried out in 48 healthy Chinese subjects under fasting and fed conditions with a randomized, open-label, two-formulation, two-sequence, two-period, single-dose crossover design. In each period of the study, the subjects were assigned to receive a single oral dose of 250 mg ciprofloxacin hydrochloride. Blood samples were collected from 1 hour before dosing to 36 hours after administration with 16 timepoints in total. The bioequivalence analysis was performed after ln-transformation of the ciprofloxacin pharmacokinetic parameters including Cmax, AUC0-t, and AUC0-∞. A total of 48 subjects were enrolled in the fasting and fed studies, and 1 of the subjects was excluded before drug administration. In the fasting study, the 90% CIs for the test/reference geometric mean ratios (GMRs) of the ln-transformed data for Cmax, AUC0-t, and AUC0-∞ were 85.41 - 100.97%, 95.40 - 100.27%, and 95.48 - 100.30%, respectively. For the fed study, the 90% CIs for the test/reference GMRs of the ln-transformed data for Cmax, AUC0-t, and AUC0-∞ were 90.15 - 113.75%, 99.10 - 103.77%, and 99.11 - 103.80%, respectively. These values all fell within the standard acceptance range of 80-125%. In the study, the generic (test) product of ciprofloxacin hydrochloride 250 mg was bioequivalent to the innovator (reference) product after single-, oral-dose administration under fasting and fed conditions.

Comparative Purity Study of UV Spectrophotometric and Fourier-Transform Infrared Spectroscopic (FTIR) Techniques for the Determination of Ciprofloxacin Hydrochloride Tablets

The oral bioavailability of ciprofloxacin is about 70% to 80%, with minimal loss by first pass metabolism...

In vitro quality evaluation of generic ciprofloxacin tablets available in community pharmacies of Dessie town, Northeast Ethiopia

The introduction of generic drug products from multiple sources into the health care system of many developing countries may lead to spread of substandard medicines. Post marketing surveillance is very crucial to ensure product quality and eliminate substandard medicines and consequently, ensure better patient clinical outcome. Hence, the aim of the present work was to assess the quality of six generic ciprofloxacin hydrochloride 500 mg tablets available in Dessie town, Northeast Ethiopia using in vitro quality control tests. Weight variation test, disintegration test, dissolution test and assay for the content of active ingredients were done as per the United States pharmacopoeia. All generic ciprofloxacin hydrochloride tablets were evaluated for conformity with United States Pharmacopoeial standards.The results of weight variation test indicated that all samples were complied with United States Pharmacopoeial specifications.The percentage content of generic ciprofloxacin tablets was within the range of 90–110% and the disintegration time was found between 2.375 and 6.31 min. In addition, generic ciprofloxacin tablets released more than 80% of the drug in 30 min. Hence, all generic ciprofloxacin tablets met the quality control parameters as per the United States pharmacopoeial specifications.

FORMULATION A CIPROFLOXACIN HYDROCHLORIDE EXTENDED-RELEASE TABLET WITH COMBINATION OF HYDROXYPROPYL METHYLCELLULOSE (HPMC) K100M AND HYDROXYPROPYL METHYLCELLULOSE (HPMC) K4M BY DIRECT COMPRESSION METHOD

Objective: Ciprofloxacin hydrochloride tablets which are not extended-release will produce non-constant drug levels in the blood. This study aimed to overcome this problem by making ciprofloxacin hydrochloride extended-release tablets with a combination of hydroxypropyl methylcellulose (HPMC) K100M and hydroxypropyl methylcellulose (HPMC) K4M by a direct compression method.
 Methods: The method in this study consisted of preformulation, formula design, manufacture of ciprofloxacin hydrochloride tablets, tablet print mass testing, IPC (In-Process Control) slow-release tablet mass print, IPC (In-Process Control) quality of slow-release tablet preparation, dissolution test, and statistical analysis. Preformulation was carried out aiming to determine the physical and chemical properties of active-excipient substances based on a certificate of analysis. This was done using a Fourier Transform Infrared (FT-IR) and UV-Vis spectrophotometer. Five kinds of ciprofloxacin hydrochloride tablet formulations were made using the direct pressing method with variations in the concentration of HPMC K100M and HPMC K4M. The ratio of percentage of HPMC K100M and HPMC K4M were F1 0,5%: 1%, F2 1%: 0,5%, F3 0,75%: 0,75%, F4 1%: 0%, F5 0%: 3%. Evaluation of tablet preparations (IPC control) included weight uniformity test, size uniformity test, hardness test, and friability test. The dissolution test was carried out for 2 h by hydrochloride acid 0,1 N pH 1.2 as (pH of gastric acid). Statistical analysis using Perfect Block Random Design (PBRD) method and further testing using the Newman-Keuls test was applied for the data obtained.
 Results: The test results with FTIR showed that ciprofloxacin hydrochloride used compared to ciprofloxacin hydrochloride BPFI is equivalent and has a purity index of 0.992739. Determination of the level of the active ingredient ciprofloxacin hydrochloride was carried out by measuring the absorbance of a 5 ppm sample solution at a wavelength of 276 nm. The percentage of absorbance of the solution is then calculated and the result obtained is 98.87%. The range of levels that have been set is 98%-102%. These test results were under those listed on the certificate of analysis. The results of the IPC test in the form of weight uniformity test, size uniformity test, hardness test, friability test, and uniformity of ciprofloxacin hydrochloride levels in the preparation, showed all data obtained fulfilling the requirements set by USP 36 convention (2013). The result from dissolution tablet test on 30, 60, and 120 min showed the release of active substance on F1 56.00 %, 67.76 %, and 87.57 %. F2 were 53.42 %, 65.16 %, and 91.44 %. F3 were 59.18 %, 72.15 %, and 91.20 %. F4 were 50.51 %, 70.70 %, and 95.29 %. F5 were 53.75 %, 69.55 %, and 92.05 %. Statistical analysis was applied for the data obtained. Dissolution results illustrated the level of active substances dissolved in the dissolution medium for 2 h or in other words the dissolution test results indicated the number of active substances from tablets that were released and enter the digestive tract and came in contact with body fluids.
 Conclusion: The dissolution test results as a basis of extended-release tablets showed all of the formulae met dissolution requirements of the United States Pharmacopeia (USP) 36 convention.

QUALITY CONTROL ASSESSMENT OF DIFFERENT BRANDS OF CIPROFLOXACIN 500 MG TABLETS IN YEMEN

Ciprofloxacin is a fluorinated 4-quinolone or fluoroquinolone antibacterial with a wider spectrum of activity than nalidixic acid and more favorable pharmacokinetics allowing its use in systemic infections. It has been used in the treatment of a wide range of infections. Many different brands and dosage forms of Ciprofloxacin hydrochloride are available in the Sana'a market that places health practitioners in a dilemma of drug substitution in case of non-availability of a particular brand.
 The aim of the present study was to evaluate the quality control of five brands of Ciprofloxacin hydrochloride tablets marketed and commonly prescribed in Sana'a city. The results and findings of the present study will be interpreted and discussed.
 Five brands of Ciprofloxacin hydrochloride tablets (500 mg) were purchased from the retail pharmacy outlets and their pharmaceutical quality were assessed by using in-vitro tests as per the British Pharmacopoeia (BP) and unofficial standards as recommended by the manufacturers. The assessment of tablets included the evaluation of uniformity of weight, friability, hardens, disintegration time, dissolution test and assay content by UV spectrophotometric method. All brands passed USP and BP standards in- vitro quality control tests prescribed for the tablets except hardens test but the all products were satisfactory for hardness.
 The results indicated that the overall quality of all tested Ciprofloxacin hydrochloride tablets brands was satisfactory as they met the requirements of the official and unofficial quality control tests.

Application of microcrystalline cellulose from <i>Saccharum officinarum</i> as dry binder in ciprofloxacin tablet formulation

This work was aimed at the application of microcrystalline cellulose (MCC) obtained from Saccharum officinarum stem pulp (coded MCC-Sacc) as a dry binder in the formulation of ciprofloxacin hydrochloride tablets. Formulations containing 250 mg ciprofloxacin hydrochloride powder and different ratios of MCC-Sacc were mixed dry and compressed into tablets. Some physical properties and dissolution studies of the ciprofloxacin tablets was done using the British Pharmacopoeia (BP) method. Avicel PH 102 was used as comparing standard. Res ults show tablets that conformed with BP specifications in terms of weight (300 mg ± 5 %), hardness (4.74 ± 1.41 to 6.00 ± 1.05 kg/F), friability of ≤ 1 %, and disintegration time (3.20 ± 0.01 to 3.79 ± 0.37 min). The drug dissolution studies for both MCCs showed more than 80 % release of ciprofloxacin within 60 min. Ciprofloxacin tablets containing MCC-Sacc compared favourably with those containing Avicel PH 102 in terms of uniformity of tablet weight and disintegration time. Tablets containing Avicel PH 102 were significantly (p < 0.05) harder and less friable than those containing MCC-Sacc. Thus, MCC-Sacc served as a good dry binder and has a good potential as a directly compressible excipient in the formulation of ciprofloxacin tablets.Keywords: Microcrystalline cellulose; Saccharum officinarum; Dry binder; Avicel PH 102; British Pharmacopoeia

COMPARATIVE ANTIMICROBIAL ACTIVITY OF FIVE BRANDS OF CIPROFLOXACIN SOLD IN LAGOS STATE

he antimicrobial activity of five brands (A, B, C, D and E) of ciprofloxacin hydrochloride tablets commonly sold in Lagos Nigeria, were compared and assessed against susceptible clinical isolates (Staphylococcus aureus, Escherichia coli and Salmonella enterica serotypetyphi). Susceptibility test, minimum inhibitory concentration test and the bactericidal activity were determined. All sampled brands were within their shelf life. Most (60%) of the sampled brands were made in India while the remaining 40% were made in Nigeria. All the brands complied with the official specification in British Pharmacopeia (BP) for uniformity of weight as they show less than 5% deviation in weight. The mean antibacterial activities of the brands at 25µg/ml were found to be within the range of 38.0mm to 42.2mm zone of inhibition while the MICs range between 0.012µg/ml to 1.5µg/ml.All the sampled brands were effective against all the test organisms to varying degree with brands A and E been more potent while brand D was the least effective. The order of MICs (decreasing order of potency) was D>B>C>A>E for Staphylococcus aureus and D>C>B>E>A for Escherichia coli while that of Salmonella enterica serotypeTyphiwas D>B>C>A>E. The bactericidal activity of each ciprofloxacin brand D and E are concentration-dependent; with brand E more active at all tested concentrations.

SYNTHESIS AND CHARACTERIZATION OF A NOVEL MUCOADHESIVE DERIVATIVE OF PSYLLIUM SEED POLYSACCHARIDE

Objective: In the present study, thiol-functionalization of psyllium seed polysaccharide (PSY) was cross-linked with thioglycolic acid by esterification in an attempt to reveal the mucoadhesive properties of thiolated psyllium seed polysaccharide (TPSY).Methods: The crosslinking was carried out by the microwave-assisted method. A simplex centroid design was employed to systematically study the mucoadhesive strength, mucoadhesive retention time and drug release profile. Comparative evaluation of carbopol-based ciprofloxacin hydrochloride (HCl) tablets containing PSY and TPSY was carried out. Acute oral toxicity studies and repeated oral toxicity for TPSY were also conducted.Results: Thiol-functionalization was confirmed by-SH stretch in Fourier Transform infra-red spectra at 2353 cm-1. Thiolation was observed in thiolated PSY (TPSY) by a change in the surface morphology of psyllium from fibrous to granular and resulted in 82 %swelling in deionized water. TPSY was found to contain 102.35 mmol of thiol groups/g as determined by the Ellman’s method. The percent increase in mucoadhesive strength of TPSY was found to be 50.31 % as compared to PSY and 128.30 % as compared to carbopol. The percent increase in mucoadhesive retention time of TPSY was found to be 110 % as compared to PSY and 50 % as compared to carbopol.Conclusion: Mucoadhesion strength and mucoadhesive retention time were greater of tablets containing a higher amount of TPSY. Further, the acute oral toxicity studies and repeated oral toxicity for TPSY proved it as non-toxic and hence safe for human use.

Effect of Sunlight, Moisture, Temperature and Ultraviolet Radiation on the Quality Control Parameters of Ciprofloxacin Tablet Formulation

<p>This work assesses the stability and quality of Ciprofloxacin hydrochloride tablets after subjection to accelerated stability conditions of sunlight, temperature of 40±1<sup>0</sup>C, 75% relative humidity, and UV light of 365 nm for 4 hours each day. This study was performed at time zero and at 4-day intervals for a period of 45 days (that is, days 0, 4, 8, 12…40, 44) according to the International Conference on Harmonization (ICH) accelerated aging conditions and the results obtained were subjected to statistical analysis. The results showed that with increasing time there was a gradual reduction in the dissolution rate with the tablets exposed to all four storage conditions failing the test on day 44 where they had less than 80 % release of the label claim. For content of Ciprofloxacin Hydrochloride, only those tablets exposed to UV light passed the test for all 44 days as they had a minimum of 96.83 % content on the 44<sup>th</sup> day. At day 0, all the tablets assayed passed this test, having a ciprofloxacin content of 99.43 %. For those tablets subjected to the other storage conditions including temperature of 40±1<sup>0</sup>C, 75 % relative humidity and sunlight, they had ciprofloxacin content of 70.22 %, 71.50 %, and 78.36 % respectively. The results further, indicated that the storage conditions used in the study had a greater impact on the dissolution behavior and content of the Ciprofloxacin tablets than they did on the physical stability (hardness, uniformity of weight, disintegration).</p>

Therapeutic effects of ciprofloxacin/bushenhuazhuo combination on chronic prostatitis

Purpose: To evaluate the clinical effect of bushenhuazhuo (a Chinese traditional medicine) in combination with ciprofloxacin (an orthodox medicine) in chronic prostatitis (CP) therapy.Methods: A total of 160 patients who suffered from CP and received treatment in the People’s Hospital of Zhengzhou between April 2012 and June 2014 were selected and divided randomly into treatment and control groups, with 80 patients in each group. Control group was given 0.25 g ciprofloxacin hydrochloride tablets twice a day for 4 weeks. In addition to ciprofloxacin administration, patients in the treatment group also received a dose of bushenhuazhuo preparation twice daily for 4 weeks. Clinical outcomes, quality of life as well as lecithin body and white blood cell (WBC) count in expressed prostatic secretions (EPS-WBC) were evaluated.Results: Cure rates in the treatment and control groups were 90 and 72.50 %, respectively; this difference was significant (p < 0.05). Scores for National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), WBC, and lecithin bodies in the treatment group (8.20 ± 2.20 points, 4.50 ± 1.20 points, and 28.10 ± 2.10 points, respectively) were higher (p < 0.05) than for the control group (12.20 ± 2.20, 6.30 ± 2.20, and 23.30 ± 2.90 points, respectively). The levels of interferon (IFN)-γ and tumour necrosis factor (TNF)-α in the treatment group (26.20 ± 3.30 and 33.80 ± 5.40 mg/L, respectively) were lower than those in the control group (37.70 ± 3.90 and 48.40 ± 3.70 mg/L, respectively), whereas the level of interleukin (IL)-10 in the treatment group (292.60 ± 23.70 mg/L) was higher (p < 0.05) than that in control group (235.80 ± 25.90 mg/L).Conclusion: Ciprofloxacin combined with the Chinese traditional medicine, bushenhuazhuo preparation, demonstrates a marked therapeutic effect in CP. Its mechanism of action may be related to decreased levels of IFN-γ and TNF-α and increased IL-10.Keywords: Bushenhuazhuo, Interferon – γ, Ciprofloxacin, Chronic prostatitis symptom index

In-vitro bioequivalence, physicochemical and economic benefits study for marketed innovator and generic ciprofloxacin hydrochloride tablets in Saudi Arabia

Comparative in vitro dissolution study of Aceclofenac Marketed Tablets in Two Different Dissolution Media by Validated Analytical MethodS.M. Ashraful Islam, Sharmi Islam, Mohammad Shahriar, Irin Dewan

Evaluation of a Poly (Acrylic) Acid Polymer as a Sustained Release Matrix for Ciprofloxacin Hydrochloride

An evaluation of the sustained release (SR) properties of a polyacrylic acid polymer, Carbopol 971(CP 971) as matrix in the formulation of ciprofloxacin hydrochloride (CH) tablets was carried out. The CP 971 in concentrations of up to 40 % w/w were wet granulated using ethanol 95% v/v and the dried granules were evaluated for packing, densification and flow properties. The tablets were evaluated for hardness, friability, uniformity of weight and content of active ingredient. The formulations dissolution profiles were tested in 0.1 N Hydrochloric acid (0.1 N HCl, pH 1.3), simulated gastric fluid (SGF, pH 1.2) and simulated intestinal fluid (SIF, pH 7.2) without enzymes. Results obtained showed significant retardation (p < 0.05) of ciprofloxacin release as the polymer concentration increased. Drug release was significantly different in the three media used with the release rate being faster in SGF than 0.1 N HCl and SIF. This can be attributed to the high solubility of the drug in acidic media. More than 50% of drug content was released within 4 h. Ciprofloxacin tablets containing 20 % w/w was adjudged the best formulation and drug release from the formulation was diffusion controlled (Fickian).

Development and validation of a thin-layer chromatographic-densitometric method for the analysis of ciprofloxacin hydrochloride tablets

Ciprofloxacin [1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazin-1-yl)quinoline-3-carboxylic acid hydrochloride] (Figure 1) is freely soluble in water (3.5 g dL–1) and less soluble in organic solvents such as methanol (0.016 g dL–1) [1, 2]. It is a second-generation fluoroquinolone chemotherapeutic agent used worldwide as antibacterial and has strong effect on Gramnegative bacteria and weak effect on Gram-positive bacteria. It is used in the treatment of infections of the urinary tract, airways, alimentary tract, skin and soft tissues, bones, arthritis, infections caused by Pseudomonas bacteria, and serious general infections [3, 4].

Formulation and Evaluation of Swellable and Floating Gastroretentive Ciprofloxacin Hydrochloride Tablets

Drugs that have narrow absorption window in the gastrointestinal tract (GIT) will have poor absorption. For these drugs, gastroretentive drug delivery systems offer the advantage in prolonging the gastric emptying time. Swellable, floating, and sustained release tablets are developed by using a combination of hydrophilic polymer (hydroxypropyl methylcellulose), swelling agents (crospovidone, sodium starch glycolate, and croscarmelose sodium) and effervescent substance (sodium bicarbonate). Formulations are evaluated for percentage swelling, in vitro drug release, floating lag time, total duration of floating, and mean residence time (MRT) in the stomach. The drug release of optimized formulation follows the Higuchi kinetic model, and the mechanism is found to be non-Fickian/anomalous according to Krosmeyer-Peppas (n value is 0.68). The similarity factor (f (2)) is found to be 26.17 for the optimized formulation, which the release is not similar to that of marketed produced (CIFRAN OD). In vivo nature of the tablet at different time intervals is observed in the radiographic pictures of the healthy volunteers and MRT in the stomach is found to be 320 +/- 48.99 min (n = 6). A combination of HPMC K100M, crospovidone, and sodium carbonate shows the good swelling, drug release, and floating characters than the CIFRAN OD.

Solubility behavior and biopharmaceutical classification of novel high-solubility ciprofloxacin and norfloxacin pharmaceutical derivatives

The hydrochlorides of the 1:3 aluminum:norfloxacin and aluminum:ciprofloxacin complexes were characterized according to the Biopharmaceutics Classification System (BCS) premises in comparison with their parent compounds. The pH–solubility profiles of the complexes were experimentally determined at 25 and 37 °C in the range of pH 1–8 and compared to that of uncomplexed norfloxacin and ciprofloxacin. Both complexes are clearly more soluble than the antibiotics themselves, even at the lowest solubility pHs. The increase in solubility was ascribed to the species controlling solubility, which were analyzed in the solid phases at equilibrium at selected pHs. Additionally, permeability was set as low, based on data reported in the scientific literature regarding oral bioavailability, intestinal and cell cultures permeabilities and also considering the influence of stoichiometric amounts of aluminum. The complexes fulfill the BCS criterion to be classified as class 3 compounds (high solubility/low permeability). Instead, the active pharmaceutical ingredients (APIs) currently used in solid dosage forms, norfloxacin and ciprofloxacin hydrochloride, proved to be BCS class 4 (low solubility/low permeability). The solubility improvement turns the complexes as potential biowaiver candidates from the scientific point of view and may be a good way for developing more dose-efficient formulations. An immediate release tablet showing very rapid dissolution was obtained. Its dissolution profile was compared to that of the commercial ciprofloxacin hydrochloride tablets allowing to dissolution of the complete dose at a critical pH such as 6.8.

Comparative evaluation of the biopharmaceutical and chemical equivalence of some commercially available brands of ciprofloxacin hydrochloride tablets

Purpose: This study was undertaken with the objective of evaluating the biopharmaceutical equivalency of ten brands of ciprofloxacin tablets and the chemical equivalency with the use of an analytical method, which will be easy to use, accurate, reproducible, simple, and inexpensive. Method: The biopharmaceutical and chemical equivalence of ten brands of ciprofloxacin hydrochloride tablets were assessed through the evaluation of the uniformity of weight, friability test, hardness, disintegration test, dissolution rate, thin layer chromatography and non-aqueous titration procedure with the use of crystal violet solution indicator. Result: All the brands complied with the official specification for uniformity of weight and friability test, while one of the brands failed the disintegration test. The dissolution rate profile revealed that four of the brands did not attain 70% dissolution throughout the period of the determination, while the other brands had above 70% dissolution at less than 45minutes. The non-aqueous titrimetric procedure showed that the excipients did not affect the procedure; with seven brands having values within the range specified in the USP, while the remaining three brands gave lower values. Conclusion: Six of the brands evaluated in this study could be regarded as being biopharmaceutically and chemically equivalent, while a particular brand is obviously a fake product. The non-aqueous titrimetric procedure used in this study is simple, inexpensive, and easy to use and could be used in routine monitoring of the quality of ciprofloxacin HCl tablets, especially in the absence of high technology equipments that are not easily available in most developing countries. Keywords : Ciprofloxacin hydrochloride tablets, non-aqueous titration, chemical equivalence, biopharmaceutical equivalence > Tropical Journal of Pharmaceutical Research Vol. 6 (3) 2007: pp. 737-745

Statistical Evaluation of in Vitro Dissolution of Different Brands of Ciprofloxacin Hydrochloride Tablets and Capsules

The in vitro dissolution of ciprofloxacin from commercially available tablets and capsules in China was studied using the USP apparatus I to compare the product performance from nine different manufacturers. Cumulative release grater than 75% was obtained from all of the products tested within 45 min. However, statistically significant differences were found between some of the products when in vitro data were analyzed using the Weibull function, similarity factor (f2), and multivariate analysis of variances.