Pantoprazole Sodium Research Articles

Exploring potential drug-drug interactions in discharge prescriptions: ChatGPT's effectiveness in assessing those interactions.

Potential drug-drug interactions (pDDIs) pose substantial risks in clinical practice, leading to increased morbidity, mortality, and healthcare costs. Tools like Micromedex drug-drug interaction checker are commonly used to screen for pDDIs, yet emerging AI models, such as ChatGPT, offer the potential for supplementary pDDI prediction. However, the accuracy and reliability of these AI tools in a clinical context remain largely untested. This study evaluates pDDIs in discharge prescriptions for medical ward patients and assesses ChatGPT-4.0's effectiveness in predicting these interactions compared to Micromedex drug-drug interaction checker. A cross-sectional study was conducted over three months with 301 discharged patients. pDDIs were identified using Micromedex drug-drug interaction checker, detailing each interaction's occurrence, severity, onset, and documentation. ChatGPT-4.0 predictions were then analyzed against Micromedex data. Binary logistic regression analysis was applied to assess the influence of predictor variables in the occurrence of pDDIs. 1551 drugs were prescribed to 301 patients, averaging 5.15 per patient. pDDIs were detected in 60.13% of patients, averaging 3.17 pDDIs per patient, ChatGPT-4.0 accurately identified pDDIs (100% for occurrence) but had limited accuracy for severity (37.3%) and moderate accuracy for onset (65.2%). The most frequent major interaction was between Cefuroxime Axetil and Pantoprazole Sodium. Polypharmacy significantly increased the risk of pDDIs (OR: 3.960, p<0.001). pDDIs are prevalent in internal medicine discharge prescriptions, with polypharmacy heightening the risk. While ChatGPT 4.0 accurately identifies pDDI occurrence, its limitations in predicting severity, onset, and documentation underscore healthcare professionals' need for careful oversight.

Leveraging machine learning to predict drug permeation: impact of menthol and limonene as enhancers.

The present study aimed to develop robust machine learning (ML) models to predict the skin permeability of poorly water-soluble drugs in the presence of menthol and limonene as penetration enhancers (PEs). The ML models were also applied in virtual screening (VS) to identify hydrophobic drugs that exhibited better skin permeability in the presence of permeation enhancers i.e. menthol and limonene. The drugs identified through ML-based VS underwent experimental validation using in vitro skin penetration studies. The developed model predicted 80% probability of permeability enhancement for Sumatriptan Succinate (SS), Voriconazole (VCZ), and Pantoprazole Sodium (PS) with menthol and limonene. The in vitro release studies revealed that menthol increased penetration by approximately 2.49-fold, 2.25-fold, and 4.96-fold for SS, VCZ, and PS, respectively, while limonene enhanced permeability by approximately 1.32-fold, 2.27-fold, and 3.7-fold for SS, VCZ, and PS. The results from in silico and in vitro studies were positively correlated, indicating that the developed ML models could effectively reduce the need for extensive in vitro and in vivo experimentation.

Determination of dimethyl sulfate genotoxic impurity in pantoprazole sodium sesquihydrate by derivatization method and UPLC/MS

In this study, a new method has been developed and, the method has been validated to analyze dimethyl sulfate (DMS) which known as a genotoxic impurity. DMS has been detected in trace levels within the drug substance pantoprazole sodium sesquihydrate using the derivatization method. Triethylamine has been used as derivatization reagent. Due to the highly polar nature of the derivatization product, which is a quaternary ammonium ion, a polar retention Hilic column has been used for chromatographic separation. The Waters QDA detector has been used in the single ion recording (SIR) mode at m/z 116 for the detection of the quaternary ammonium ion. In this study, the recovery rates have been achieved within the range of 96.46–105.98%. The LOD has been determined as 1.94E-07 mg/mL, and the LOQ has been determined as 6.46E-07 mg/mL. From the results, it can be said that the improved method in this study, would enables fast and reliable solutions for routine quality control analyses for DMS in API companies that especially is producing PSS.

Design and optimization of pantoprazole sodium mucoadhesive hydrogel microcapsules for the healing of peptic ulcers

Design and optimization of pantoprazole sodium mucoadhesive hydrogel microcapsules for the healing of peptic ulcers

Development and Validation of Chromatographic Methods for Simultaneous Estimation of Aspirin and Pantoprazole Sodium in Pure and Mixture Form.

This technique is employed for the simultaneous quantification of aspirin (ASP) and pantoprazole sodium in both pure powder form and formulations. The high performance liquid chromatography (HPLC) method uses a C-18 column (250mm × 4.6mm, 5μm) with a mobile phase consisting of 0.05M disodium hydrogen phosphate and methanol in a 40:60% v/v ratio. The flow rate is maintained at 1.0mL/min. On a layer of silica gel 60F254 with an aluminum backing, the high performance thin layer chromatography (HPTLC) separation was carried out with ethyl acetate and methanol (8: 1.5v/v) as the mobile phase. With a mean recovery of 100.54% and 99.55% for ASP and PNT, respectively, quantification was accomplished using the HPLC method with UV detection at 286nm over the concentration range of 0.1-0.6g/mL for PNT and 0.4-2.4g/mL for ASP. With a mean recovery of 99.44% and 99.01% for ASP and PNT, respectively, quantification was achieved using the HPTLC method with UV detection at 298nm over the concentration range of 400-2400ng/spot for ASP and 100-600ng/spot for PNT, respectively. The methods can be used for the simultaneous determination of ASP and PNT in pure powder form and formulations as they are simple, accurate and sensitive.

Repurposing of US-FDA-approved drugs as negative modulators of ubiquitin specific protease-7 (USP7)

Ubiquitin-specific protease7 (USP7) regulates the stability of the p53 tumor suppressor protein and several other proteins critical for tumor cell survival. Aberrant expression of USP7 facilitates human malignancies by altering the activity of proto-oncogenes/proteins, and tumor suppressor genes. Therefore, USP7 is a validated anti-cancer drug target. In this study, a drug repurposing approach was used to identify new hits against the USP7 enzyme. It is one of the most strategic approaches to find new uses for drugs in a cost- and time-effective way. Nuclear Magnetic Resonance-based screening of 172 drugs identified 11 compounds that bind to the catalytic domain of USP7 with dissociation constant (Kd) values in the range of 0.6–1.49 mM. These 11 compounds could thermally destabilize the USP7 enzyme by decreasing its melting temperature up to 9 °C. Molecular docking and simulation studies provided structural insights into the ligand-protein complexes, suggesting that these compounds bind to the putative substrate binding pocket of USP7, and interact with its catalytically important residues. Among the identified 11 hits, compound 6 (oxybutynin), 7 (ketotifen), 10 (pantoprazole sodium), and 11 (escitalopram) also showed anti-cancer activity with an effect on the expression of proto-oncogenes and tumor-suppressor gene at mRNA level in HCT116 cells. The compounds identified in this study can serve as potential leads for further studies.

FORMULATION AND DEVELOPMENT OF BIOADHESIVE PELLETS FOR MANAGEMENT OF HELICOBACTER PYLORI INFECTION

Helicobacter pylori, a gram-negative bacterium, is a group I carcinogen which is responsible for duodenal ulcer, gastric ulcer, and gastric cancer. The existing treatment is based on the use of proton pump inhibitors, but is inadequate owing to factors such as low concentration of drug reaching the target site, short residence time, and resistance to activity. Intending to mitigate these limitations, bioadhesive pellets of tinidazole and pantoprazole sodium sesquihydrate for the management of H. pylori infection were developed. Tinidazole-loaded pellets will act on gastric mucosa and pantoprazole-loaded pellets will release the drug in the intestine. Readily dispersible bioadhesive pellets were formulated by extrusion spheronization using Noveon® AA and hydroxypropyl methyl cellulose (HPMC) as the matrix-forming polymers and microcrystalline cellulose as the core-forming agent. The size of placebo pellets was 1.192±0.017mm. Pantoprazole pellets were coated with Eudragit® S100 to achieve sustained drug release in the intestine. In vitro release studies of pellets showed that 98.331±0.456% and 99.438±0.465% of tinidazole and pantoprazole, respectively were released by the end of 8 h. Ex vivo mucoadhesion study on the gastric mucosa of goat demonstrated a mucoadhesive force of 2.3544±0.02 N. The study thus indicates that the developed formulation sustains the release of tinidazole as well as pantoprazole sodium and could prove to be efficacious and promising for H. pylori eradication at lower doses, reduced adverse effects, and enhanced bioavailability.

Drug compatibility with various closed intravenous infusion containers.

Objective: The aim was to systematically compare the drug compatibility with various closed intravenous (i.v.) infusion containers, to provide a reference for selecting a relatively superior infusion container and improve the medication safety for patients in clinical practice. Methods: The compatibility of four commonly used clinical injections (ceftazidime, pantoprazole sodium, ambroxol hydrochloride, edaravone) with three representative closed i. v. infusion containers (non-PVC infusion bags, upright polypropylene infusion bags, inner sealed polypropylene infusion bags) prefilled with infusion fluids (0.9% sodium chloride or 5% dextrose) in the Chinese market were investigated in this study. The particle counts of both infusion fluids and diluted chemical injections by infusion fluids in various infusion containers were determined by the light obscuration method. At 0, 2 and 6h after four injections following dilution with infusion fluids in each container, the pH of the solutions was detected, and the physical properties were examined by visual inspection. Meanwhile, the drug concentrations were assessed by high performance liquid chromatography (HPLC). Results: As for either infusion fluids or diluted injections by infusion fluids, the particle counts in non-PVC infusion bags were significantly greater than those in the other two bags under some circumstances. The particle counts in diluted injections by infusion fluids increased dramatically compared with those in infusion fluids in all infusion containers, especially for the small-size particles. But pH, physical properties and drug concentrations of diluted infusion solutions in all infusion containers remained nearly unchanged over the test period. Conclusion: Closed i. v. infusion containers included in this study are all well-compatible with four injections. Moreover, the closed infusion containers produced by Chinese manufacturers have met the international quality standard. Particularly, the intravenous admixture preparation process needs to be optimized to reduce the overall particulate contaminants.

RSM optimized chitosan based composite hydrogel for sustained drug delivery applications

Hybrid hydrogels with good biocompatibility have practical applications in the field of drug delivery. However, it remains challenging to formulate the hybrid hydrogels for sustained drug release by regulating their pore size and degradation rates. Herein, a hybrid chitosan-alginate hydrogel (superabsorbent) was synthesized using maleic acid as a cross-linker and acrylamide as a grafting agent. The composite hydrogel exhibited a good swelling percentage of 1246% (at pH 10), analysed using response surface methodology (RSM). The hybrid hydrogel system was hemocompatible as well as biocompatible and utilized for drug delivery applications. Pantoprazole sodium was taken as a model drug and it was loaded in the superabsorbent using the swelling diffusion method. The composite hydrogel showed excellent encapsulation efficiency for pantoprazole sodium (99.74%). The intermolecular interactions between hydrogel and drug were examined using different analytical techniques including XRD (X-Ray Diffraction), FTIR (Fourier transform infrared), SEM (Scanning electron microscope), thermal analysis and EDX (Energy dispersive X-ray) mapping. The swelling percentage of the drug loaded hydrogel under simulated gastrointestinal conditions was recorded as 917.80% (at stomach pH 1.2) and 756.95% (at intestinal pH 7.4) where protonation/deprotonation of the drug in the hydrogel matrix played an important role. In vitro drug release from the drug-loaded hydrogel was sustained up to 10 days and correlated with its swelling tendency, displaying higher release profiles at pH 1.2 (99.69%) than at pH 7.4 (72.16%). The pore volume of hydrogel was tuned varying the cross-linker amount during synthesis. BET (Brunauer-Emmett-Teller) results revealed that the pore volume of the hydrogel varied between 0.01775–0.01327 cm3/g for the cross-linker amount between 0.18–0.26 g, respectively. The impact of various factors including amount of cross-linker, pore volume, and drug loading percentage on drug release at pH 1.2 and 7.4 was studied statistically as well as experimentally and these factors significantly controlled the drug release percentage. The drug release from the hydrogel followed the Makoid-Banakar model with Fickian diffusion mechanism. The synthesized composite chitosan-alginate hydrogel could be a promising candidate for its utilization as a sustained drug delivery system.

Box-Behnken guided development of an ecofriendly RP-HPLC analytical method for simultaneous quantification of pantoprazole sodium and piperine co-loaded mucoadhesive GRDDS formulation for H. pylori eradication

Helicobacter pylori (H. pylori) infection is the leading cause of chronic peptic ulcer disease worldwide. Many treatment options are available to treat H. pylori infection. However, the eradication is still a challenge due to the poor bioavailability of the currently available formulations. To improve the efficacy of therapy, novel formulations are necessary. Proton pump inhibitors (PPIs) are already a part of the treatment regimen with antibiotics. P-glycoprotein (P-gp) inhibitor was reported to have increased the efficacy of antibiotic treatment in H. pylori infections. To make available the P-gp inhibitor and PPI on the intestinal mucosal surface we have formulated a gastroretentive drug delivery system (GRDDS) as an adjuvant therapy with antibiotics. The objective of this study is to simultaneously estimate pantoprazole (PAN) and piperine (PIP) by reverse-phase (RP) high-performance liquid chromatography (HPLC) method from the chitosan-based sodium alginate mucoadhesive beads utilizing the design of experiments (DOEs) methodology. The HPLC settings were optimized using DOEs software. The final optimized HPLC method used a hyperclone Octadecylsilane C18 column as the stationary phase and methanol: ammonium acetate at pH 4.5 (70:30 v/v) as the mobile phase. The flow rate was 0.9 ml/minute. The validation of the developed RP-HPLC method was done as per the International Conference on Harmonization (ICH) Q2(R1) guideline. The method was linear from 0.5 to 20 μg/ml for both PAN and PIP with an R2 value of 0.999 and 0.999, respectively. The validated RP-HPLC method showed specificity for both drugs despite interference from degradation products and other GRDDS excipients. The entrapment efficiency of the final formulation was determined to be 80%–85% for PAN and 60%–67% for PIP. The novelty and merit of the DOE-based method development are that it reduces the number of trials, thereby reducing reagent wastage, and is environmentally friendly suggested by the Green Analytical Procedure Index (GAPI) tool scoring six green, six yellow, and three red.

Stability Indicating HPLC Method for In-vitro Determination of Pantoprazole Sodium and its Degradation Products in Simulated Gastric and Intestinal Fluids

Background: A high-performance liquid chromatography (HPLC) method was developed for the determination of Pantoprazole Sodium (PPZ) in the presence of its degradation products. The degradation of PPZ was studied in simulated intestinal fluid (SIF) and simulated gastric fluids (SGF) in various temperature conditions. Aim: This study aimed to establish a simple, sensitive, and rapid RP HPLC method for in-vitro determination of Pantoprazole Sodium and its degradation products in simulated gastric and intestinal fluids. Objective: Pantoprazole is acid labile drug. In order to determine pantoprazole in various oral dosage forms, the stability-indicating assay of PPZ was performed in phosphate buffer (pH 6.8) representing simulated intestinal fluid (SIF) and in 0.1 molars (M) Hydrochloric acid (HCl) as simulated gastric fluid (SGF) at two different temperature conditions, i.e., 25°C and 0°C, respectively. Method: Pantoprazole sodium was obtained from the Akums laboratory in Haridwar. The analysis was performed by high-performance liquid chromatography (HPLC), Shimadzu, equipped with two LC-10 AD VP solvent-delivery modules, a SPD-10A UV–-visible detector, and a manual injector valve with 20 μL sample loop. Phenomenex ODS analytical column (150 mm × 4.6 mm i.d., 5 μm particles) was done under reversed-phase partition chromatographic conditions. The mobile phase was phosphate buffer and acetonitrile (ACN) of pH 7.4, respectively, optimized in a 70:30 (v/v) ratio followed by filtration through a 0.45 μm membrane filter and degassed by ultrasonicator before use. The mobile phase was delivered at the flow rate of 2 mL/min. The various parameters, such as linearity, accuracy and precision of the analytical method, were studied. Result: The standard curve of PPZ was linear (R2&gt;0.99) over the concentration range of 5-30 μg/mL, and the relative standard deviation (RSD) values for intra-day and inter-day variations were in the range of 1.0-1.8%. The range of RSD was within ±2. Conclusion: The stability of PPZ in aqueous solution was pH dependent. The rate of degradation increases with decreasing pH. The pH stability of pantoprazole was studied at the above-mentioned temperature conditions. The PPZ peaks were analyzed by comparing them with fresh samples and were stable in SIF solution after 24 hours elapsed time at pH 6.8. The obtained degraded peaks in SGF (pH 1) were successfully separated from the PPZ.

QUALITY RISK ASSESSMENT AND DESIGNED EXPERIMENTS ORIENTED SIMULTANEOUS QUANTIFICATION OF ASPIRIN AND PANTOPRAZOLE SODIUM USING DRIFTS AND UFLC-DAD METHODS

Systematized and reliable analytical methods are always of great advantage for the quality control of new drug products. Two new analytical methods were developed and validated using the multivariate approach to quantify a unique combination of aspirin and pantoprazole sodium. In the first method, emphasis was on non-destructive identification with quantification of aspirin and pantoprazole at their characteristic diffused reflectance-based infrared absorption band at 1747cm-1(-C=O) and 1303cm-1 (-S-O), respectively. The second method relies on liquid chromatographic separation using a mobile phase of acetonitrile: phosphate buffer pH 3.5 (60:40 V/V) at a flow rate of 1.0 mL min-1 using a C-18 column. At 240 nm, the diode array detection was performed. Employing risk assessment revealed the risky method parameters that may influence the preciseness of the present methods. Nevertheless, these techniques were linear, sensitive and reliable for the quick and simultaneous measurement of the analytes in bulk and proposed fixed-dose commercial formulation.

Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study.

To estimate the incidence rates (IR) of prespecified outcomes of interest in pediatric patients (1month to < 1year) treated with intravenous (IV) pantoprazole using Optum's longitudinal electronic health records database (Optum Market Clarity) from the United States (US). This real-world, non-interventional, retrospective cohort study was conducted from 01 January 2007 to 31 December 2020 in patients who received IV pantoprazole. Premature patients and those weighing < 2.36kg were excluded. Patients were categorized based on diagnosis of gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) into: Subgroup 1 (GERD and EE), Subgroup 2 (GERD and no EE), and Subgroup 3 (absence of GERD and EE). Overall IRs (per 1000 person-years [PY]) and 95% confidence intervals (CI) of outcomes were estimated (overall and subgroups) and stratified by duration of IV pantoprazole treatment (< 4days versus ≥ 4days). Of 1879 eligible patients, none were identified in Subgroup 1; 851 (45.3%) and 1028 (54.7%) patients were identified in Subgroups 2 and 3, respectively. IRs of outcomes of interest ranged from 0.0 to 742.8 per 1000 PY. IRs were highest for vomiting (742.80), diarrhea (377.77), abdominal distension (214.31), hyponatremia (204.99), and hypokalemia (203.49). IRs were comparable between Subgroups 2 and 3. For most outcomes, IRs were higher among patients treated with IV pantoprazole for ≥ 4days versus those treated for < 4days. These results are consistent with the known safety profile of pantoprazole and emphasize the utility of using real-world data from pediatric populations for assessment of safety outcomes.

Enteric coated microgranules of pantoprazole sodium in gastroesophageal reflux disease

Enteric coated microgranules of pantoprazole sodium in gastroesophageal reflux disease

Solubility enhancement of pantoprazole sodium sesquihydrate through supercritical solvent: Machine learning based study

Theoretical/experimental measurement and optimization of solubility is considered as an active field of research in different scientific areas such as pharmaceutics. Novel orally administered therapeutic medicines have recently suffered from low solubility and bioavailability. Therefore, finding better methods to improve the drug solubility and bioavailability are of prime importance. Application of CO2 supercritical fluid (CO2SCF) as a well-known procedure has attracted numerous attentions in pharmaceutical industry to increase the drug solubility and bioavailability due to its low flammability, reasonable cost, and negligible detrimental impacts for ecosystem. Pantoprazole sodium sesquihydrate is an extensively-used drug, which is indicated for the alleviation of the undesirable signs ofesophagitiscaused by stomach acid due togastroesophageal reflux disease(GERD). The purpose of this research is to analyze and optimize the solubility of Pantoprazole sodium sesquihydrate using four different tree-based models where we have temperature and pressure as input features. These models include the regression tree, the boosting model based on it (gradient boosting), the bagging model based on it (random forest), and finally a more recently developed boosting model (extreme gradient boosting). All of these models, after optimization with their hyper-parameters, show an R2-score of more than 0.9. Finally, extreme gradient boosting was selected as the main model of this work, which has a 1.07 × 10-2 maximum error and an RMSE error rate of 5.85 × 10-3.

Development and validation of stability indicating RP-HPLC method for determination of aspirin and pantoprazole sodium in synthetic mixture stability indicating HPLC method

The present study describes a new accurate and precise stability indicating reverse phase HPLC method for quantitative computation of pantoprazole sodium and Aspirin from physical simulated mixture. The proposed chromatographic method employs Hypersil ODS C18 column (250 x 4.6 mm, 5μ) as the stationary phase and combination of methyl alcohol and water in ratio of 70: 30 v/v as the elution medium. Overall separation was carried out at 0.8 ml/minute flow rate and elution was monitored at 254 nm. The proposed system gave well resolved peak of Aspirin and Pantoprazole sodium with elution time of 2.32 and 5.85 minute respectively. Same system was effective in separation of active components and degradation products when the components were subjected to forced degradation as per regulatory guidelines (ICHQ1). Finally, the optimized method was successfully validated as per ICH Q2R1 guidelines and applied for quantitative analysis of both active components in synthetic mixture.

The effect of food vehicles on in vitro performance of pantoprazole sodium delayed release sprinkle formulation

Certain patient populations, including children, the elderly or people with dysphagia, find swallowing whole medications such as tablets and capsules difficult. To facilitate oral administration of drugs in such patients, a common practice is to sprinkle the drug products (e.g., usually after crushing the tablet or opening the capsule) on food vehicles before consumption which improves swallowability. Thus, evaluation of the impact of food vehicles on the potency and stability of the administered drug product is important. The aim of the current study was to evaluate the physicochemical properties (viscosity, pH, and water content) of common food vehicles used for sprinkle administration (e.g., apple juice, applesauce, pudding, yogurt, and milk) and their impacts on the in vitro performance (i.e., dissolution) of pantoprazole sodium delayed release (DR) drug products. The food vehicles evaluated exhibited marked difference in viscosity, pH and water content. Notably, the pH of the food as well as the interaction between food vehicle pH and drug-food contact time were the most significant factors affecting the in vitro performance of pantoprazole sodium DR granules. For example, the dissolution of pantoprazole sodium DR granules sprinkled on food vehicles of low pH (e.g., apple juice or applesauce) for short durations remained unchanged compared with the control group (i.e., without mixing with food vehicles). However, use of high pH food vehicles (e.g., milk) with prolonged contact time (e.g., 2 h) resulted in accelerated pantoprazole release, drug degradation and loss of potency. Overall, a thorough assessment of physicochemical properties of food vehicles and formulation characteristics are a necessary part of the development of sprinkle formulations.

Electroanalytical sensors-based biogenic synthesized metal oxide nanoparticles for potentiometric assay of pantoprazole sodium

ABSTRACT Two modified coated membrane sensors were designed and tested. Pantoprazole-phosphotungstate was prepared by a reaction of pantoprazole with phosphotungstic acid in the solvent mediator o-nitrophenyloctyl ether. Two metal oxide nanoparticles nickel oxide and iron oxide nanoparticles, were synthesized from green sources Matricaria recutita flowers and Salvia officinalis leaves extracts, respectively. These nanoparticles were used for the potentiometric assay of pantoprazole sodium in the authentic sample and commercial products. The results showed that the improved nickel oxide and iron oxide nanosensors exhibited linearity using the concentration range of 1.0 × 10−9–1.0 × 10−2 and 1.0 × 10−10–1.0 × 10−2 mol L−1, respectively compared with 1.0 × 10−6–1.0 × 10−2 mol L−1 for the normally coated sensor. The lower limits of detection (7.6 × 10−6, 2.3 × 10−10, 2.8 × 10−11 mol L−1) and quantification (1.0 × 10−6, 1.0 × 10−9, 1.0 × 10−10 mol L−1) were determined for each of the three proposed sensors. Least squares calculations gave EmV = (27.266 ± 0.5) log (pantoprazole) + 433.37, EmV = (30.967 ± 0.3) log (pantoprazole) + 432.24 for the enriched nano-metal oxides, and EmV = (26.642 ± 0.6) log (pantoprazole) + 443.69 for the conventional type, respectively with correlation coefficients around 0.999 for the proposed sensors. The accuracy and precision of the modified potentiometric systems were estimated and the results showed excellent validity and suitability for the determination of pantoprazole in an authentic sample.

Design of Experiments as a Tool to Optimize the Process of Coating Minitablets with Commercial Gastro-Resistant Coating Mixtures.

According to the Quality by Design (QbD) concept, Design of Experiment (DoE) was used to indicate critical process parameters and optimize the fluid bed coating of minitablets in a laboratory size batch. Full factorial design was employed to increase knowledge of the process for three kinds of minitablet (MT) cores using two commercial gastro-resistant coating mixtures. The statistical analysis showed that different critical process parameters were indicated for the tested minitablets: X3: the coating mixture flow rate for MTs with pantoprazole sodium and Eudragit L; X2: the product temperature; X3 and X4: the spraying pressure for MTs with pantoprazole sodium and Acryl Eze II; and X1 and X2: MTs with diclofenac sodium. Such differences were the result of features, such as the sub-coat, size, and mass of the cores and the core and coating mixture composition. No optimal parameters were found for any of the tested MT types. Therefore, DoE should be considered as a statistical tool to individually optimize the process for the product, equipment, and tested parameters. However, optimization of the fluid bed coating allowed us to predict the values of the process parameters necessary to obtain good-quality products. Therefore, fluid bed coating may be successfully used to obtain modified-release MTs of high quality after applying the statistical tool DoE.

Biodistribution Study of Pantoprazole Sodium in Rodent Tissues

Background: Pantoprazole sodium is one of the most widely used drugs for treating gastric acid–related disorders as well as is the most popular drug among various cancer therapy protocols for treating gastric disturbances pertained to the chemotherapy. The present study aims to validate high-performance liquid chromatographic (HPLC) method for the quantification of pantoprazole sodium in mice plasma and various tissue homogenates including kidney, heart, prostate, lung, pancreas, liver, and brain. Pantoprazole sodium estimation was done using 100 μL aliquot, which was injected into HPLC system, and the separation was achieved using Shimadzu C18 column at 40°C. Mobile phase composed of acetonitrile/dibasic phosphate buffer (40:60, v/v), pH = 7.4 was isocratically pumped at 1.0 mL min-1, and detection was performed at wavelength of 290 nm. Material and Methods: All the samples including tissues and plasma were collected after 4 h of oral administration of pantoprazole sodium to Swiss albino mice (10 mg/kg, p.o.). Results: Bioanalytical method was further validated according to the standard guidelines and portrays to be selective as well as linear (r2 ≥ 0.999) over the concentration range of 10–50 ng/injection. The intraday (% relative standard deviation [RSD] = 0.29%–1.21%) and inter-day precision (%RSD = 0.52%–2.88%) was found to be within the layout standards by International Council for Harmonization. Pantoprazole sodium extraction recovery was achieved between 64.15% and 78.17% demonstrating the suitability of the method. Conclusion: Bio-distribution study so carried out by bioanalytical technique can be used as an aiding tool for the quantification of pantoprazole sodium in all the studies involving the pharmacokinetic profiling of drug in various tissues of rodents.