International Journal of Pharmaceutical Quality Assurance最新文献

{"title":"Pharmaceutical and Clinical Assessment of Multi-source Tegretol Sold in Egypt","authors":"Sarah K Amer, Hany Eldeeb, AG Eshra","doi":"10.25258/ijpqa.14.3.36","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.36","url":null,"abstract":"across generic Narrow therapeutic index (NTI) medications compared to brands. However, little attention has been given to possible inequality within the same brand due to transportation and storage conditions, production site, manufacturing condition, and product specification requested by different countries. Market surveys has shown that Egypt is one of the countries suffering from this problem, which consequently augments the need for comparing and evaluating brand products marketed under the same brand name, manufactured in different countries under its own licensing trademark™ and sold in Egypt. This work studies the drug carbamazepine (CBZ) available in Egypt as Tegretol® tablets used as an oral first-line anti-epileptic drug (AED). Objectives: The present work investigate and evaluate the pharmaceutical quality and clinical efficacy of Tegretol®, obtained from Egypt and Saudi Arabia and being marketed and sold in Egypt from 2020 to 21. Methods: In-vitro quality testing included potency and uniformity of content tests performed according to USP 2019 monograph. Dissolution rates were also carried by adopting USP dissolution test for the drug. Studies of stability were adjusted at 25°C/65% RH, 45°C/75% RH and 10°C/15% RH. The clinical efficacy was studied by evaluating the pharmacokinetics parameters and blood sodium level during six months of therapy. Results: Variability between multisource Tegretol® brand products were ensured. Potency results and uniformity of content revealed statistically significant difference between Tegretol® sources. Also, variations in dissolution rates were recognized in both Tegretol® sources when dissolved in HCL/KCL, Acetate and Phosphate Buffer dissolution media. Dissimilarities were obtained for hardness and friability testing. Furthermore, a pharmacokinetically and pharmacodynamically inequivalence was ensured. Hence, hyponatremia was more prominent in patients receiving Saudi Arabian Tegretol® compared to patients taking Egyptian Tegretol®. Conclusion: Interchangeability between multi-source Tegretol brand products should be limited.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135866869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In-vitro Antioxidant and Anti-Inflammation Activities of Ethanol Extract from “Bang Chang” Thai Cultivar Chili Pepper (Capsicum annuum Var. acuminatum)","authors":"Kanittada Thongkao, Yuttana Sudjaroen","doi":"10.25258/ijpqa.14.3.38","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.38","url":null,"abstract":"Chili peppers (Capsicum spp.) are really important crops in several Asian countries. In Thailand, chili pepper cultivars are also a wide range of flavors, colors, shapes, and spiciness levels. The cultural importance in Thai cuisine. The “Bang Chang chili pepper” (Capsicum annuum var. acuminatum), a Thai cultivar of capsicum, had first cultivated in Bang Chang subdistrict, Samut Songkhram, Thailand. This study aimed to determine capsaicin, phenolic compounds and flavonoids and screen ethanol extract’s biological activities. The extract’s average capsaicin and total phenolic content (TPC) was 10.4 ± 0.3 (g/100 mL and 2.50 ± 0.13 mg GAE/g, while it could not determine flavonoids. The low amount of capsaicin in extract was defined this cultivars as non-pungent capsicum (0-700 Scoville Heat Units, SHU). This extract was strongly scavenged NO and DPPH radicals (IC50 = 0.09 ± 0.02 and 14.88 ± 1.59 mg/mL). There was also exerted in-vitro anti-inflammation activity by suppression of albumin breakdown (IC50 = 0.51 ± 0.05 mg/mL), which, can comparable to control, diclofenac diethyl ammonium (IC50 = 0.45 ± 0.01 mg/mL). Therefore, lipid peroxidation was weakly inhibited (IC50 >1,000 mg/mL) and unable to trap metals compared to vitamin E and EDTA. According to our finding, this extract was exerted biological properties like antioxidant and anti-inflammation, as well as being non-pungent, it can be used externally for medicinal purposes like as a muscle relaxant and massage oil to reduce subcutaneous fat. This extract can be used as a condiment in Asian recipes and other healthful dishes","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stability Indicating LC-MS/MS Method Development and Validation for the Quantification of Cabotegravir in Biological Samples","authors":"Palakollu D S Sankar, Naresh Panigrahi","doi":"10.25258/ijpqa.14.3.49","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.49","url":null,"abstract":"The major goal of current research study was to create a sensitive tandem mass spectrometric method using electrospray ionisation and liquid chromatography for quantifying cabotegravir in biological matrices. A stationary Phenomenex C18 column with dimensions of 50 × 4.6 mm and 5.0 μm particle size of was used to achieve chromatographic elution. With the flowing rate of 0.80 mL/min, isocratic separation was done using methanol and 0.10% V/V HCOOH in a fraction of 85:15 V/V as the mobile phasic system. For drug and internal standard separation, liquid-liquid extraction was carried out using methanol and ethyl acetate (1:4) solvent solution. On repeated reaction monitoring, fragment and product ionic values were seen at m/z 406.12→142.04 for cabotegravir and 450.12→160.03 for bictegravir internal standard. Drug’s linearity graph had a r2 value of 0.9998 and was rectilinear at concentrations between 400 and 16000 ng/mL. The inter- and intra-batch accuracy %relative standard deviation values ranged from 2.54 to 5.21. The percent recovery results of the lower quality control (LQC), median quality control (MQC), and higher quality control (HQC) sample solutions were 102.85, 97.84, and 94.27%, respectively. This approach has excellent recoveries. Studies on stability were processed under various circumstances, and stability values ranged from 92.93 to 103.89%. When exposed to various stability conditions, cabotegravir is more steady for a longer time, and the approach was successfully applicable to routine examination of cabotegravir in biological samples.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"74 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preterm Labor with Side Effects: Compare the Effectiveness of Magnesium Sulfate (MgSO4) with Isoxsuprine","authors":"Yamini Patil, Padmaja A Havle, Shivaji V Raje, Gauri Shinde","doi":"10.25258/ijpqa.14.3.55","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.55","url":null,"abstract":"Background: In India, 25% of pregnancies develop preterm labor (PTL), resulting in 10 to 69% cases of preterm birth. Medical intervention to stop labor, reduce infection rate, and avoid infant respiratory distress has been the subject of studies for a long time. PTL patients usually get tocolytics, corticosteroids, antibiotics, and other clinically symptomatic and supportive therapy to accomplish this goal. Studies further showed that these tocolytic drugs lower intracellular calcium bioavailability via biochemical pathways, hindering the interaction of actin-myosin. Due to the poor success rate of labor arrest, researchers concluded from their studies that widespread adoption of medical management for PTL has been hampered. The high rate of major side effects of tocolytic drugs, particularly beta-mimetic ones, exacerbated this. We know of no clinical evidence on PTL management in India. Objective: The effectiveness and maternal side effects of MgSO4 and isoxsuprine in PTL arrest. Methods: In our study, we included a total of 82 pregnant women who had PTL discomfort and were admitted to the labor department. Both groups were randomly assigned patients. “Group 1 patients received isoxsuprine hydrochloride, whereas group 2 patients received MgSO4”. After that, a comprehensive clinical examination included vital signs, general, systemic, external genitalia, and PV (per vaginal) results. Investigations include CBC, BT, CT, urine full examination, ABO, RH group, serum electrolytes, RBS, vaginal swab, and Renal function test (RFT). Result: Significant difference (p <0.05) indicated that MgSO4 was more effective. Conclusion: MgSO4 can be used as a tocolytic agent in PTL as it shows better tolerance capacity when compared to isoxsuprine.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"313 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135866585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dasatinib and Hesperidin Loaded Nano Formulation and Preclinical Evaluation for Anticancer Activity","authors":"Moinuddin ., Sachin Neekhra, SK Swarnkar, Puneet Gupta, Deepa Gupta, Alok Khunteta, Ujjwal Kaushik, Saeem Ahmad","doi":"10.25258/ijpqa.14.3.20","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.20","url":null,"abstract":"In this study, we aimed to develop Dasatinib/hesperidin-loaded-SLNs for chronic myeloid leukemia (CML). Utilizing a high-shear homogenizer for the synthesis, “central composite design (CCD)” was used to enhance the dasatinib/hesperidin loaded-SLNs. The optimized SLNs had PDI, particle size, and average entrapment efficiency of 0.12%, 162.3 nm, and 93%, respectively. Therefore, by enhancing the total amount of Compritol as well as sonication time the polydispersity was increased. Poloxamer 188 content had a significant influence in decreasing the polydispersity index and the entrapment efficiency (EE) of the SLN was found to be 93%. Through TEM, SEM, FTIR, DSC, and HPLC analysis, SLNs were characterized, and their anticancer efficiency was assessed in both in-vitro and in-vitro cell viability tests (MTT). SLNs containing dasatinib and hesperidin have rounded and spherical shape having a diameter of 200 nm. DSC and FTIR tests showed compatibility between the drugs and excipients. The drug release from optimized SLN formulation was under observation for 48 hours. It was found that the medication released its drug components over a protracted period of time, with 30% of the drug being released in the first four hours and the remainder 76% in the next 48 hours. According to the IC50 values determined by an independent study, dasatinib, hesperidin, and SLN were 33.97, 5158, and 4.03 μg/mL, respectively. A comparison of SLN and free drugs revealed that SLN was more effective at cytotoxicity. In this study, dasatinib and hesperidin-loaded SLNs for chronic myeloid leukemia (CML) against HL60 human leukemia cell lines were prepared and evaluated using a novel formulation approach free of toxic excipients.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antitussive Activity of Alcoholic Extract of Piper longum Linn.","authors":"Anjali Bedse, Ashwini Nalawade, Pallavi Kamandar, Anita Wagh, Komal Mahajan, Shilpa Raut, Suchita Dhamane","doi":"10.25258/ijpqa.14.3.53","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.53","url":null,"abstract":"The l-phellandrene and caryophyllene found in Piper longum fruits are effective against a wide range of infections, including stomachic, bronchitis, spleen, cough, tumor, and asthma. This study reports preparing and characterizing alcohol-soluble extract of P. longum L. fruit powder. FTIR spectroscopy and TLC were used to characterize an alcoholic extract of P. longum. P. longum L. alcohol soluble extract was tested for its anti-tussive efficacy using the standard mouse cough model caused by ammonia liquor. Cough frequency was inhibited by 49.51% (Marketed formulation), 50.84% (Extract 100 mg/kg), 62.71% (Extract 200 mg/kg). Statistically significant (p <0.001) difference was observed in %inhibition of cough frequency of both doses of extract when compared with the marketed formulation. This study reveals an anti-tussive activity of alcohol soluble extract of P. longum L.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"99 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation and Evaluation of Film-Coated Alalevonadifloxacin Mesylate Tablet using Opadry®","authors":"Phutane PK, Salunke SA, Kokate SV, Gunde MC, Suruse PB","doi":"10.25258/ijpqa.14.3.22","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.22","url":null,"abstract":"Purpose: In this work, film-coated tablets of the antibiotic alalevonadifloxacin mesylate (AFM) were made using Opadry® yellow as the film coating material, and their different parameters, including in-vitro drug release, were assessed. Method: Direct compression was used in the production of film-coated tablets of AFM. The film-coating substance was an aqueous coating dispersion that was opadry yellow. In 900 mL of 0.1N HCL solution, the film-coated tablets’ rate of dissolution was assessed. In-vitro drug release was also evaluated. The generated film-coated tablets’ stability was assessed in accordance with ICH recommendations. Result: The coated tablets were subjected to gastrointestinal pH testing to ascertain the effectiveness of the film coating, and high-performance liquid chromatography was used to assess drug release. The coated tablets were in perfect condition. The AFM release satisfied the study’s requirement of being at least after 30 minutes, 80% was dissolved in a 0.5% HCl solution. Conclusion: According to these results, opadry yellow aqueous film coating is a simple, repeatable, and affordable method for creating stable AFM film-coated tablets without changing the properties of the medication release.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"177 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Derivatization of Proline for the Enantiomeric Separation and Estimation of D-Proline in L-Proline by NP-HPLC","authors":"Gampa Nagamalleswari, M.S Umashankar","doi":"10.25258/ijpqa.14.3.52","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.52","url":null,"abstract":"The core object of this exertion is to progress and validate a modest, competent and explicit method for the exodus of D and L isomers of proline in a racemic mixture and limit the content of D-Proline in commercial L-Proline. This has been technologically advanced in a chiral method using normal phase HPLC on CHIRALPAK-IA (250X4.6 mm) 5 μ column. This progress advanced with polar mobile phase ethanol encompassing modifier/additive TFA in 0.1% concentration. Due to the chromophore’s deficiency in proline, proline’s derivatization has been done using fluorescent reagent NBD-Cl. After derivatization, proline has made UV detectable at 465 nm. Within run time of 20 minutes, D and L isomers of proline were eluted at 6.72 and 9.22 minutes, respectively. The technologically advanced method was validated as per ICH guidelines. Linearity regression coefficients for both D and L-Proline are obtained as 0.999. Retrieval for D-Proline was obtained at 93 to 95% range for 4 levels. LoD and LoQ for both D- and L-Proline were detected as 0.6 and 2 ppm, respectively. Hence this method is newer, modest, particular and explicit chiral method.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Simultaneous Estimation for Diosgenin, Charantin and Hydroxychalcone from Herbal Antidiabetic Formulation using Validated HPTLC Method","authors":"Archana Naik, Chhaya Gadgoli, Nikita Patil, Ruchira Salunkhe","doi":"10.25258/ijpqa.14.3.26","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.26","url":null,"abstract":"Most antidiabetic polyherbal preparations contain Trigonella foenum-graecum, Momordica charantia and Cinnamomum zeylanicum as active components. Although all ingredients are popular as antidiabetic agents, but the analytical method is not available for simultaneous estimation of marker compounds from herbal formulations due to several challenges. Hence, the HPTLC method was developed for simultaneous estimation of three active phytoconstituents viz. diosgenin, charantin and hydroxychalcone in polyherbal formulation. The stationary phase of the optimized HPTLC method is silica gel 60 GF254 and the mobile phase is chloroform: glacial acetic acid: methanol: water (4:3:2:1v/v). The Rf value of phytoconstituents charantin, diosgenin, and hydroxychalcone was found to be 0.72, 0.61 and 0.30 at detection wavelength 342 nm. According to ICH criteria, the analytical method validation was performed. All three markers showed linear and proportional responses in the 400 to 1400 ng/band range, which confirmed the markers’ linearity. Precision measurements were made at the intraday and interday levels, and the results were satisfactory and in line with the specifications. Accuracy was determined by the recovery method and %recovery was found to be in the range of 85.20 to 97.19. The validated HPTLC method was utilized to analyze the marketed Quanto Diab Forte capsule formulation containing charantin, diosgenin, and hydroxychalcone. The proposed validated analytical method was found to be simple, precise and accurate.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preparation and In-vitro Evaluation of Pemigatinib Nanosponges Tablets by Box-Behnken Design","authors":"Palanati Mamatha, DVRN Bhikshapathi","doi":"10.25258/ijpqa.14.3.56","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.56","url":null,"abstract":"Objective: Pemigatinib depicted antitumor action in complex and metastatic tumors and it’s a hydrophobic compound having strong pH-reliant solubility. The current work was designed to improve oral solubility of pemigatinib by incorporating into nanosponges (NSs). Methods: Box-Behnken Design optimized the independent parameters of polystyrene NSs formation. Polystyrene NSs were prepared by ultrasound-assisted method using diaryl carbonate as cross-linking agent, which were later characterized and formulated into tablets. Tablets got screened for the respective quality attributes. Results: A number of tests were carried out from the test runs generated by a three-factor, three-level BBD. The range of mean PS was 153 to 316 nm, the range for encapsulation efficiency% was 68.2 to 91.4%, and the value for PDI was 0.273 to 0.445. ZP for the finalized formula was determined to be -29.1 mV. The drug and excipients were compatible as confirmed by FTIR studies. SEM study confirmed that pemigatinib has successfully entrapped in interior of the polymer. In-vitro examination of the pemigatinib loaded NSs tablets were compared with a marked product and satisfactory results were obtained (98.74 ± 2.65% vs. 93.73 ± 1.06%). The prepared formulations were stable during 6 month stability study period. Conclusion: The study findings for pemigatinib NS tablets demonstrated quick dissolution since the changed solubility qualities of the drug, satisfying the intended objective of increased absorption. Formulated pemigatinib-loaded NSs can be beneficial in the treatment of cancers","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135866874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}