Ranitidine Tablets Research Articles

Liquid Chromatography with Tandem Mass Spectrometric Method Development and Validation Study for the Estimation of N-Nitrosodimethylamine in Ranitidine Tablets

Liquid Chromatography with Tandem Mass Spectrometric Method Development and Validation Study for the Estimation of N-Nitrosodimethylamine in Ranitidine Tablets

Duloxetine in Reducing Catheter-Related Bladder Discomfort: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study.

The excessive desire to void with discomfort in the supra-pubic region, which is experienced postoperatively by patients who underwent urinary catheterization, is known as catheter-related bladder discomfort. In this study, we evaluated duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in preventing catheter-related bladder discomfort. Around 64 adults (18-60 years), of either sex, with American Society of American Society of Anesthesiologists (ASA) physical status I and II, scheduled to undergo elective gastrointestinal carcinoma surgeries under general anesthesia were analyzed in the final assessment of 2 comparative groups C and D of 32 patients each. Group D received 1 ranitidine tablet of 150 mg and 1 duloxetine tablet of 60 mg, while group C patients received 2 tablets of ranitidine of 75 mg 2 hours prior to induction. A 16 F Foley catheter was used to catheterize bladder intra-operatively, and 10 mL of distilled water was used to fill the balloon. At 0, 1, 2, and 6 hours, the catheter-related bladder discomfort was evaluated, and categorized into none, mild, moderate, and severe. The study drug's adverse effects, if any, were reported. At all-time intervals, group D had lower incidence and severity of catheterrelated bladder discomfort than group C (P < .05). Compared to group C, patients in group D had a higher incidence of nausea, dizziness, and vomiting; nevertheless, the difference was statistically insignificant (P > .05). Duloxetine of 60 mg given orally 2 hours before induction decreases the incidence and severity of catheter-related bladder discomfort.

Definition of multivariate acceptance limits (guard-bands) applied to pharmaceutical equivalence assessment

The quality assessment of medicines involves multiple compliance parameters, such as identity, dosage, purity, potency, content uniformity, disintegration time, dissolution rate, among others. The measurement uncertainty associated with a measured value can affect the conformity assessment and, consequently, it impacts decision-making. Even if the particular risks are acceptable, the total risk may be significantly high. Thus, the aim of this work was to develop a procedure for the definition of acceptance (or rejection) limits applied to multiple compliance assessments, that ensure acceptable particular and total risks. The multiple compliance assessments were performed and applied in the pharmaceutical equivalence studies for cisplatin injectable solution, carboplatin injectable solution, ranitidine tablets, and acetaminophen oral solution from several manufacturers. Pharmaceutical equivalence studies were performed adopting pharmacopeial analytical procedures. All chromatographic system suitability results complied with the requirements regarding the resolution between peaks, the capacity factor, the tailing factor, the theoretical plates, and the relative standard deviation for replicate injections. Univariate and multivariate guard-bands (g and g′, respectively) were calculated by multiplying the standard uncertainty (u) by an appropriate univariate and multivariate coverage factor (k and k′, respectively).The values of multivariate guard band (g′) were higher than the values of univariate guard bands (g), which leads to more restrictive acceptance intervals. Measured values between the conventional and the multivariate acceptance limits will ensure particular risk values below the maximum acceptable value, however, the total risk may be significantly high. On the other hand, measured values within the multivariate acceptance limits ensure that particular risk values and total risk value are below the maximum acceptable value The application of multivariate guard bands is a simple way to ensure reduced particular and total risks of false conformity decisions, which is of great interest to regulatory agencies and the manufactures of the medicines.

Rapid UV-Vis spectroscopy methods for quantification of ranitidine tablets

Ranitidine is a histamine H2-receptor antagonist that inhibits gastric acid secretion, commonly used in the treatment and prophylaxis of peptic ulcer and gastroesophageal reflux disease. Over-the-counter ranitidine hydrochloride tablets are available in several European countries as well as the US for the relief of indigestion and heartburn. Commercial tablets containing the equivalent of 150 mg of ranitidine were analysed following extraction. Ranitidine is water-soluble, thus avoiding the use of organic solvents. Standard aqueous solutions of ranitidine hydrochloride were used to construct a calibration curve. This graduate laboratory experiment describes a simple, inexpensive, safe, and “green” procedure for the quantification of ranitidine tablets by UV spectrophotometry. The entire procedure provides an pedagogical opportunity to approach a realistic analytical scenario, typical of a quality control laboratory, by designing an attractive and engaging hands-on session. An average content of 148 ± 1 mg of ranitidine was determined using both standard addition and external calibration methods and results are in agreement with Pharmacopoeia. Keywords: Analytical chemistry, ranitidine, drugs/pharmaceuticals, quantitative analysis, UV-Vis spectroscopy

A Study of Adsorption Dynamics of Biologically Active Plants

Abstract: Alstonia scholaris is a biologically active and important Devil tree. The medicinal importance pharmacology importance in particulars antiulcer activity of Alstonic scholaris in albino rats were Analyzed and reported. The juice of Alstona scholaris to rats show a remarkable record with respect to ranitidine tablet (to cure ulcer). This result initiate the author to study chemo mimetic nature of plant material for the removal of heavy metal in synthetic solution also extended studies with modified Alstonia scholaris and Wrichitia Tinctoria. An adsorption of 96% in all the cases was observed. A linear correlation with R2 value of 0.977 was calculated from the linear plot of optical densities of Alstonia Scholaris and modified Alstonia Scholaris similar trend in adsorption was also noted. In the case of Wrightia Tinctoria instead of modified Alstonia Scholaris

In Vitro Analysis of N-Nitrosodimethylamine (NDMA) Formation From Ranitidine Under Simulated Gastrointestinal Conditions

A publication reported that N-nitrosodimethylamine (NDMA), a probable human carcinogen, was formed when ranitidine and nitrite were added to simulated gastric fluid. However, the nitrite concentrations used were greater than the range detected in acidic gastric fluid in prior clinical studies. To characterize NDMA formation following the addition of ranitidine to simulated gastric fluid using combinations of fluid volume, pH levels, and nitrite concentrations, including physiologic levels. One 150-mg ranitidine tablet was added to 50 or 250 mL of simulated gastric fluid with a range of nitrite concentrations from the upper range of physiologic (100 μmol/L) to higher concentrations (10 000 μmol/L) with a range of pH levels. NDMA amounts were assessed with a liquid chromatography-mass spectrometry method. NDMA detected in simulated gastric fluid 2 hours after adding ranitidine. At a supraphysiologic nitrite concentration (ie, 10 000 μmol/L), the mean (SD) amount of NDMA detected in 50 mL simulated gastric fluid 2 hours after adding ranitidine increased from 222 (12) ng at pH 5 to 11 822 (434) ng at pH 1.2. Subsequent experiments with 50 mL of simulated gastric fluid at pH 1.2 with no added nitrite detected a mean (SD) of 22 (2) ng of NDMA, which is the background amount present in the ranitidine tablets. Similarly, at the upper range of physiologic nitrite (ie, 100 μmol/L) or at nitrite concentrations as much as 50-fold greater (1000 or 5000 μmol/L) only background mean (SD) amounts of NDMA were observed (21 [3] ng, 24 [2] ng, or 24 [3] ng, respectively). With 250 mL of simulated gastric fluid, no NDMA was detected at the upper physiologic range (100 μmol/L) or 10-fold physiologic (1000 μmol/L) nitrite concentrations, while NDMA was detected (mean [SD] level, 7353 [183] ng) at a 50-fold physiologic nitrite concentration (5000 μmol/L). In this in vitro study of ranitidine tablets added to simulated gastric fluid with different nitrite concentrations, ranitidine conversion to NDMA was not detected until nitrite was 5000 μmol/L, which is 50-fold greater than the upper range of physiologic gastric nitrite concentrations at acidic pH. These findings suggest that ranitidine is not converted to NDMA in gastric fluid at physiologic conditions.

Application of Measurement Uncertainty on Conformity Assessment in Pharmaceutical Drug Products.

Conformity assessment in pharmaceutical drug products usually are based on analytical results. An analytical result always is associated with an uncertainty which must be considered in a compliance assessment. The objective of the present project aims to estimate the measurement uncertainty associated with the results of average weight, assay, uniformity of content, and dissolution testing in ranitidine tablets manufactured by two different companies (X and Y). The uncertainty was evaluated using the Monte Carlo method. The particular and total risks of false acceptance decisions (consumers' risks) were also estimated by the Monte Carlo method. The results for ranitidine tablets manufactured by company X were (359.2 ± 2.7) mg of average weight, (108.6 ± 1.6)% of assay, (11.4 ± 2.8) of acceptance value for uniformity of content, and (89.4 ± 1.3)% for dissolution testing. The results for company Y were (312.5 ± 0.9) mg, (107.0 ± 1.4)%, (7.2 ± 1.7), and (93.6 ± 1.3)%, respectively. A 95% confidence level was adopted. According to results obtained from the Monte Carlo simulations, the results of average weight, assay of ranitidine, and uniformity of content are significantly correlated due to shared analytical steps. The correlation between values significantly affected the risk of false decisions. Consumers' risks were estimated for both ranitidine tablets and their results ensure compliance for ranitidine tablets manufactured by companies X and Y. The use of measurement uncertainty is an important issue regarding the conformity/non-conformity assessment of pharmaceutical products.

Temperature-Dependent Formation of N-Nitrosodimethylamine during the Storage of Ranitidine Reagent Powders and Tablets.

The purpose of this study was to elucidate the effect of high-temperature storage on the stability of ranitidine, specifically with respect to the potential formation of N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. Commercially available ranitidine reagent powders and formulations were stored under various conditions, and subjected to LC-MS/MS analysis. When ranitidine tablets from two different brands (designated as tablet A and tablet B) were stored under accelerated condition (40 °C with 75% relative humidity), following the drug stability guidelines issued by the International Conference on Harmonisation (ICH-Q1A), for up to 8 weeks, the amount of NDMA in them substantially increased from 0.19 to 116 ppm and from 2.89 to 18 ppm, respectively. The formation of NDMA that exceeded the acceptable daily intake limit (0.32 ppm) at the temperature used under accelerated storage conditions clearly highlights the risk of NDMA formation in ranitidine formulations when extrapolated to storage under ambient conditions. A forced-degradation study under the stress condition (60 °C for 1 week) strongly suggested that environmental factors such as moisture and oxygen are involved in the formation of NDMA in ranitidine formulations. Storage of ranitidine tablets and reagent powders at the high temperatures also increased the amount of nitrite, which is considered one of the factors influencing NDMA formation. These data indicate the necessity of controlling/monitoring stability-related factors, in addition to controlling impurities during the manufacturing process, in order to mitigate nitrosamine-related health risks of certain pharmaceuticals.

Kinetics Spectrophotometric determination of Ranitidine based on its Inhibitory effect on the Oxidation Rate of Malachite green by N-bromosuccinide

A simple and sensitive kinetic spectrophotometric method is described for the determination of ranitidine. The method is based on the inhibiting effect of ranitidine on the rate of oxidation of malachite green (MG+ ) with N-bromosuccinimide (NBS) The oxidation reaction was followed spectrophotometrically by measuring the rate of change of the absorbance of malachite green with time at λ=617nm in the presence of different concentrations of ranitidine using the recommended procedure. Ranitidine can be determined from 0.08 to 2.40 g ml-1 with a linear calibration graph and detection limit of 0.026 g ml-1 . The method was successfully applied for the determination of ranitidine in pure ranitidine samples and in ranitidine tablets. The recovery of the analyzed samples were 97-100% with relative standard deviation, sr (%) =1.14 x 10-4 indicating high accuracy and precision of the suggested method. The interference of various cations and anions in the determination of ranitidine was studied

Influence of Bile Salts as Excipients in Ranitidine, Aminophylline and Phenobarbital Tablets on Dissolution Rate

Aim: The aim of this study is to investigate the influence of bile salts, sodium cholate, sodium 12-ketocholate and sodium dehydrocholate, as excipients in ranitidine, aminophylline and phenobarbital tablets on dissolution rate. Methods: Four groups of tablets (control without bile salts and three investigational groups containing different bile salts) were prepared for three different drug substances: ranitidine, aminophylline and phenobarbital. Dissolution rate was measured. Results: Dissolution rate is increased significantly in all investigational groups comparing to the control group in all three drug substances. Discussion: Presented results are very favourable and encouraging in case of dissolution enhancing and should be further investigated, especially in drug substances that are classified in class II and IV as per Biopharmaceutical Classification System (BCS) classification. Conclusion: Bile acid salts are very promising excipients, proven to act as surfactants and as lubricants. Running title: Bile salts as excipients in ranitidine, aminophylline and phenobarbital tablets.

Simultaneous UV Spectrophotometric Methods for Estimation of Ranitidine and Domperidonein Bulk and Tablet Dosage Form

Simultaneous UV Spectrophotometric Methods for Estimation of Ranitidine and Domperidonein Bulk and Tablet Dosage Form

Evaluation of the Pharmaceutical Quality of Different Brands of Ranitidine Tablets Manufactured in Bangladesh: A Pharmaceutical and Public Health Prospective

Drug counterfeiting and production of substandard drug is a global problem. This study was aimed to assess the pharmaceutical quality of ranitidine hydrochloride tablets manufactured in Bangladesh. Tablets were collected from different parts of Bangladesh and quality parameters were evaluated according to the United States Pharmacopoeia and the British Pharmacopoeial methods. The potency of tablets was measured spectrophotometrically. Weight variation and disintegration time were performed according to pharmaceutical monographs. Among 43 brands tested, 8 failed to comply with the USP specification (active ingredient: 90±10%) due to containing of less amount of ranitidine of which 6 brands were spurious and 2 were substandard in nature. Two brands did not comply with the specification for weight variation of tablets whereas all brands passed disintegration time test. The findings clearly demonstrate the production of substandard ranitidine tablets in Bangladesh. The drug control authority of Bangladesh should take effective steps to prevent the production of substandard drugs to secure public health.

Efficacy and safety of Aloe vera syrup for the treatment of gastroesophageal reflux disease: a pilot randomized positive-controlled trial

ObjectiveTo investigate the use of Aloe vera (A. vera) for the treatment of gastroesophageal reflux disease (GERD) symptoms and compare its effects with those of omeprazole and ranitidine. MethodsIn this pilot, randomized controlled trial, 79 subjects were allocated to A. vera syrup (standardized to 5.0 mg polysaccharide per mL of syrup) at a dose of 10 mL/d, omeprazole capsule (20 g/d) or ranitidine tablet (150 mg in a fasted state in the morning and 150 mg 30 min before sleep at night) for a period of 4 weeks. The frequencies of eight main symptoms of GERD (heartburn, food regurgitation, flatulence, belching, dysphagia, nausea, vomiting and acid regurgitation) were assessed at weeks 2 and 4 of the trial. ResultsA. vera was safe and well tolerated and reduced the frequencies of all the assessed GERD symptoms, with no adverse events requiring withdrawal. ConclusionA. vera may provide a safe and effective treatment for reducing the symptoms of GERD.

Test of dissolution and comparison of in vitro dissolution profiles of coated ranitidine tablets marketed in Bahia, Brazil

Ranitidine is an antisecretory drug with H2 antagonist action useful in treating gastric and duodenal disorders. The dissolution test is used to obtain and compare dissolution profiles and establish similarities of pharmaceutical forms. The aim of this study was to compare the dissolution profiles of 150-mg coated ranitidine tablets of a reference drug (product A) and a generic (product B) and a similar (product C) drug marketed in Bahia, Brazil using a simple, fast and inexpensive ultraviolet method. Dissolution was determined using a USP type 2 apparatus at 50 rpm with 900 mL of distilled water at 37.0 ± 0.5 oC for 1h. The dissolution test was performed in compliance with the American Pharmacopoeia (USP-32). Dissolution efficiency and difference (f1) and similarity (f2) factors were calculated and evaluated. The proposed quantification methodology for drug dissolution test was validated, presenting accuracy, linearity and precision within the acceptance criteria. Products A, B and C showed dissolution efficiency values of 59.29, 73.59 and 66.67%, respectively. Factors f1 and f2 were calculated and showed that the profiles of products A, B and C were dissimilar. However, all the products released ranitidine satisfactorily, with at least 80% of the drug dissolved within 30 min.

Appraisement of Ranitidine Hydrochloride Tablet (USP150mg) Preparations from Few Selected Companies in Bangladesh

The study was aimed to evaluate the pharmaceutical properties of few selected generic products of ranitidine hydrochloride tablets available in retail pharmacies of Bangladesh. We collected 10 nationally manufactured generic ranitidine HCl tablets from local Market who followed USP specifications and examined their physical parameters and potency to check their compliance with the USP. The intention was to evaluate the quality of this pharmaceuticals after 20 years of implementing the National Drug Policy in 1982. All tested ranitidine tablet samples (Rt1-Rt10) were selectively collected from local retail pharmacies in Savar, Dhaka-1344, Bangladesh. Before purchasing the samples, their physical appearance, name of manufacturer, batch number, date of manufacturing , expiry date, manufacturing license number and Maximum Retail Price (MRP) were properly checked. The various parameters of the selected samples such as diameter, shape, size, weight variation, thickness, hardness, disintegration, dissolution and potency have been determined according to the American Pharmacopoeia USP 27 requirements. It was found that all ten selected products met the USP 27 specification s. The differences in hardness among the tablets were significant. Interestingly, dissolution profiles of some tablet products were not weighty different from one another, whereas those of tablets were significantly different. However, all brands complied with USP 27. It could be concluded that the selected ranitidine HCl tablets met the required USP specifications and are considered quality products in terms of the mentioned parameters.

Evaluation of pharmaceutical equivalents of different brands of ranitidine tablets from multinational brands in Oman

Aim : The aim of the present study was to evaluate the pharmaceutical equivalent of different brands of Ranitide Hydrochloride tablets. Materials and Methods : Three different brands of ranitidine hydrochloride 150 mg tablets have been evaluated using some quality control test of weight variation, friability, hardness and disintegration with aim to assess whether these 3 brands are pharmaceutically equivalent or not. The results obtained have been compared with USP standards. Result : The results indicated that all the tablets in the three brands have met the requirements of the quality control test (weight variation, friability, hardness and disintegration) according to the USP which indicated that they are pharmaceutically equivalent.

Zaltoprofen, a noninferior alternative to diclofenac for the treatment of primary knee osteoarthritis – a comparative evaluation of efficacy and safety in a 4-week, multicentric, randomized, double-blind, double-dummy trial

Objective: To demonstrate the clinical noninferiority of the analgesic effect of zaltoprofen (80 mg t.i.d.) compared with diclofenac (50 mg t.i.d.) in active knee osteoarthritis patients.Method: In this multicentric, double-blind, double-dummy, randomized, parallel-group, comparative study, 213 patients of either sex, aged 40 – 65 years having radiological and clinically confirmed primary knee osteoarthritis were randomized either to zaltoprofen (n = 105) or diclofenac (n = 108) and were followed-up at weeks 1, 2, 3 and 4. The treatment period was preceded by a washout period of 1 week.Results: Patients in both the zaltoprofen and diclofenac groups exhibited significant improvement (p < 0.001) in pain intensity, functional status and pain relief at each visit from baseline with no statistically significant difference between the two treatment groups. There was no statistically significant difference between the treatment groups for global assessment rating done by the patient and investigator at the end of therapy (p > 0.05) and the proportion of patients who consumed ranitidine (p = 0.135) and paracetamol (p = 0.086) tablets during the treatment period on both the treatment arms. Both the study medications were well tolerated with no incidence of serious adverse events.Conclusions: This study demonstrated that efficacy and safety of zaltoprofen is clinically noninferior to that of diclofenac.

Efficacy and Safety of Aceclofenac-CR and Aceclofenac in the Treatment of Knee Osteoarthritis: A 6-Week, Comparative, Randomized, Multicentric, Double-Blind Study

The efficacy and safety of aceclofenac control release (CR) tablets was compared with conventional aceclofenac tablets in patients with knee osteoarthritis (OA). This was a double-blind, double-dummy, randomized, parallel group multicentric study conducted at 6 centers. Two hundred and eighty five patients were randomized to either aceclofenac-CR (n = 143) once daily or conventional aceclofenac tablet (n = 142) twice daily and were followed for 6 weeks. The efficacy parameters were pain intensity score on visual analogue scale, Western Ontario and McMaster (WOMAC) score, patients and investigator’s overall study drug assessment and total consumption of acetaminophen and ranitidine tablets. Both treatments showed significant improvement in their efficacy parameters from baseline at the end of therapy. Aceclofenac-CR was comparable to conventional aceclofenac with respect to change in pain intensity and WOMAC score (P > .05) There was no statistically significant difference between the treatment groups in patient’s and investigator’s overall study drug assessment at the end of therapy (P > .05). Aceclofenac-CR treated patients took fewer acetaminophen and ranitidine tablets during the treatment period as compared to conventional aceclofenac treated patients. Both the study medications were well tolerated with no incidence of serious adverse event (SAE). In conclusion, the new aceclofenac-CR formulation was found to be effective and safe while offering practical advantage of once daily administration. PerspectiveThis article represents the advantages of control release aceclofenac over the conventional aceclofenac tablets. Aceclofenac-CR was found to be similar in terms of efficacy as conventional aceclofenac in knee OA patients with fewer adverse events.

Evaluating ranitidine, pantoprazole and placebo on gastric pH in elective surgery

Background and Aim:Concern about the grim nature of postoperative acid aspiration syndrome grew among the anesthesiologist over the years warranting the need for pre-emptive intervention. The aim of the study is to compare the effects of preoperative oral ranitidine versus pantoprazole given in regulating gastric pH in elective surgery.Methods:This prospective, parallel group, controlled, randomized, single-blind study was conducted at a tertiary care postgraduate teaching institute at Kolkata, involving 120 participants of either sex, aged 18-60 years of American Society of Anesthesiologists physical status I and II, who were scheduled for elective surgery under general anesthesia lasting for more than 2 h. The participants were divided into three groups. In group A (n=40) participants received placebo tablet, in group B (n=40) participants received ranitidine tablet while in group C (n=40), participants received pantoprazole tablet and their gastric pH estimated serially.Results:The participants in the three groups were comparable in terms of age, sex, body weight, duration of surgery and type of surgery distribution. In regard to changes in gastric pH trends, there was no statistically significant difference between serial pH values in group A (Friedman test; P>0.05) and group C participants. (P>0.05). However, the mean preoperative gastric pH values (7.140±.7652) were significantly lower than mean pH values (7.253±.7514) after 2 h postoperatively in group B participants (P<0.05).Conclusion:From the observations and analyses of the present study, it can be inferred that ranitidine is more effective than pantoprazole to raise the gastric pH for prevention of aspiration pneumonitis.

Comparative Bioavailability of Ranitidine Tablets in Healthy Volunteers

The pharmacokinetic parameters of domestic and imported ranitidine hydrochloride tablets (Ranitidine, formulated and manufactured by Kharazmi Pharmaceuticals, Iran, and Zantac  manufactured by Glaxo, UK) were measured in 14 healthy subjects following oral administration of a single 300-mg dose of each brand and compared for bioequival ence evaluation. The pharmaceutical equivalency of both formulations was shown by in vitro characterization and dissolution testing. The comparative bioavailability of the two products was then determined in a single-blind, single dose, randomized, cross-over study in 14 healthy volunteers. A sensitive, rapid and precise high performance liquid chromatography (HPLC) method was used to measure concentrations of ranitidine in plasma samples collected up to 12 hours following each dose. Pharmacokinetic param eters, including C max, Tmax, AUC0-t, AUC0-∞, elimination rate constant (k) and hal f life were determined for both formulations. Analysis of the data revealed that the vari ations in all pharmacokinetic parameters were not statistically significant (p> 0.05), and the 90% confidence intervals for the test/reference mean ratios of the plasma pharmacokinetic variabl es lie within the conventional bioequivalence range of 80-125%. Therefore, both formulations were comparable based on the in vitro characterization and were bioequivalent in terms of Cmax and AUC. The two formulations were considered to be bioequivalent.