Dirgahayuni Sari Agustina, Ambarita, P. Oktamianti, I. Gusti, Ayu Trisnadewi, Dirgahayuni Sari, Agustina Ambarita
{"title":"ANTIBIOTICS IN INDONESIA: ACCESS, WATCH, AND RESERVE CLASSIFICATION","authors":"Dirgahayuni Sari Agustina, Ambarita, P. Oktamianti, I. Gusti, Ayu Trisnadewi, Dirgahayuni Sari, Agustina Ambarita","doi":"10.22159/ijap.2024v16i3.50351","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50351","url":null,"abstract":"Objective: The objective of this study is to compare antibiotics listed in the National Essential Medicines List (NEML) and national formulary in Indonesia by determining the proportion of antibiotics in the three groups, Access, Watch, and Reserve (AWaRe), along with median data, range values, and time trends from 2013 to 2021.\u0000Methods: We obtained the compilation of antibiotics from the NEML and national formulary in Indonesia, covering the period from 2013 to 2021. These antibiotics were evaluated according to the 2021 WHO AWaRe classification database. This analysis involved determining the proportion of antibiotics in the AwaRe groups within each healthcare facility. Median data and range values for these antibiotics were also calculated. Trends in the proportion of AWaRe antibiotics were analyzed and visualized using a line chart.\u0000Results: The Indonesian NEML includes 20 antibiotics, categorized into two tiers of healthcare settings. Of these antibiotics, 13 were access, seven were watch, and there was neither a reserve nor a not recommended antibiotic. The Indonesian national formulary includes 42 antibiotics, categorized into three tiers of healthcare settings. Of these antibiotics, 19 were access, 22 were watch, one was not recommended, and there was no reserve antibiotic. The proportion of antibiotics during the pre-and post-establishment of the WHO AWaRe in 2017 showed significant changes in the Indonesian national formulary but not in the NEML.\u0000Conclusion: In recent years, the proportions of antibiotics in the Indonesian NEML and national formulary have varied according to the WHO AWaRe classification.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"110 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003702","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":"IDENTIFICATION, SEPARATION, AND CHARACTERIZATION OF DEGRADATION PRODUCTS OF TRIAMCINOLONE HEXACETONIDE USING LC AND LC-MS/MS","authors":"Bhavna SUNIL MAHAJAN, P. Miniyar","doi":"10.22159/ijap.2024v16i3.50122","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50122","url":null,"abstract":"Objective: The study aimed to separate the forced degradation products of Triamcinolone hexacetonide using HPLC and characterize the degradation product by LC-MS/MS fragmentation pattern.\u0000Methods: Triamcinolone hexacetonide (THA) and its primary degradation products were identified using a liquid chromatography-mass spectrometry/Mass spectrometry (LC-MS/MS) approach. The degradation study was based on in-depth stress testing with acid, base, peroxide, heat, and light. A Zorbax SB C18 column and a greener mobile phase composed of methanol and 10 mmol ammonium acetate buffer in water at pH 3 were employed to accomplish separation and quantitation at a flow rate of 0.7 ml/min in an isocratic mode with a 239 nm detection wavelength.\u0000Results: A major degradation product of the drug was obtained in acidic and alkaline stress conditions. The drug was found to be stable for all other stress conditions. The LC-MS/MS analysis results of the active pharmaceutical ingredient and resulting product after degradation were interpreted to identify the novel degradation product and fragments. The developed method was validated as per International Council for Harmonization (ICH) guidelines. The square root of the correlation coefficients, which indicated linearity for THA in 50 to 150 % of the workload, was 0.99. Method Precision assay was performed on six different preparations, percentage relative standard deviation (% RSD) of assay value is 0.17 % and system precision is 0.30 %. In accuracy, overall % RSD of 50 %, 100 %, and 150 % in triplicate is 0.95.\u0000Conclusion: It is concluded that the drug is stable to all other stress conditions except for acidic and alkaline stress conditions and generates a novel degradation product. The developed LC (Liquid chromatography) method separates and identifies the degradation product.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"28 31","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141004382","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}
Karrar T. KHUDHAIR ALBO HAMRAH, A. J. NEAMAH Al-SHAIBANI, Inas F. ABDULRAZZAQ
{"title":"PREPARATION AND EVALUATION OF LAFUTIDINE NANOEMULSION AS ORAL DELIVERY SYSTEM","authors":"Karrar T. KHUDHAIR ALBO HAMRAH, A. J. NEAMAH Al-SHAIBANI, Inas F. ABDULRAZZAQ","doi":"10.22159/ijap.2024v16i3.50206","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50206","url":null,"abstract":"Objective: Lafutidine is a histamine (H2) receptor antagonist utilized for the treatment of gastric ulcer. Its oral bioavailability is low due to poor water solubility and an extensive first-pass hepatic. So, the present work aims to formulate and characterize of an oil in water (o/w) nanoemulsion of lafutidine as oral liquid dosage form and this could enhance drug solubility and improve its bioavailability.\u0000Methods: The pseudo-ternary phase diagrams were constructed via titration method. The diagram plots derived from oil, various ratios of surfactant and co-surfactant (S mix), and double distilled water. The selected optimized lafutidine nanoemulsions formula was determined via a variety of investigational studies like particle size, polydispersity index (PDI), zeta potential, pH, drug content and an in vitro drug release.\u0000Results: Characterization studies revealed that the optimum formula of nanoemulsions was (NE5), which consist of 0.2% of lafutidine, 30 % of surfactant and co-surfactant (S mix) (3:1), which mean (22.5%of tween 20:7.5% of polyethylene glycol 200 (PEG 200), 10% of peppermint oil and 59.4% of double distilled water. The optimized formula exhibited droplets size (62.56-96.2 nm), PDI (0.11), good pH value (7.1), zeta potential (-32.2 mV), high drug content (99.2%), in vitro release of lafutidine was significantly higher (P<0.05) for NE5. Scanning probe microscopy (SPM) revealed that the droplets size of NE5 was in nano-scale.\u0000Conclusion: It is possible to conclude that the optimized formula (NE5) was promised formula of nanoemulsion for increasing the orally delivered lafutidine bioavailability.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"118 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141002714","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":"BIOSYNTHESIS, CHARACTERIZATION AND EVALUATION OF SILVER NANOPARTICLES FROM THE LEAF EXTRACT OF PREMNA INTIGRIFOLIA L. AS A POTENTIAL ANTICANCER AGENT","authors":"SPANDANA K., Arun K. Shettar, R. S.","doi":"10.22159/ijap.2024v16i3.50260","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50260","url":null,"abstract":"Objective: In this study, plant-based silver nanoparticles were synthesized and characterized from Premna integrifolia leaf extract to test the viability towards anticancer properties. \u0000Methods: Preliminary identification of silver nanoparticles was validated by Visual observation and confirmed for the characterization by Scanning Electron Microscopy (SEM), Energy Dispersive X-ray Spectroscopy (EDX) and Fourier-transform Infrared Spectroscopy (FTIR) analysis. Further synthesized nanoparticles were evaluated against non-small lung cancer cells (A549) by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5 diphenyl tetrazolium bromide) assay.\u0000Results: Aqueous leaf extract of Premna intigrifolia was synthesized for silver nanoparticles and showed an average size from 35nm to 100 nm through SEM studies. EDX showed a strong signal confirming the formation of silver nanoparticles in the metallic silver region at 5Kev, and the FTIR spectrum showed changes in some peaks of the aqueous extract with functional groups. The newly synthesized silver nanoparticles showed significant anticancer properties targeting lung cancer A549 cell line against standard drug Epotoside with a 50% Inhibitory Concentration (IC50) value of 78.431 µg.\u0000Conclusion: The results affirm that biosynthesized silver nanoparticles can be used as an alternative to chemical medicines to cure cancer.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"114 S1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003511","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}
Alaa A. Hashim, Dhiya Altememy, Hussein Abdelamir Mohammad, Hasanain Shakir Mahmood, Radhwan M. HUSSEIN, Mahsa Rezaei, Pegah Khosravian
{"title":"THE FORMULATION AND EVALUATION OF 6-THIOGUANINE AS A NANOSTRUCTURE LIPID CARRIER FOR THE TARGETED DELIVERY OF BREAST CANCER","authors":"Alaa A. Hashim, Dhiya Altememy, Hussein Abdelamir Mohammad, Hasanain Shakir Mahmood, Radhwan M. HUSSEIN, Mahsa Rezaei, Pegah Khosravian","doi":"10.22159/ijap.2024v16i3.50379","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50379","url":null,"abstract":"Objective: The main goal was to avoid all the problems associated with usual breast cancer treatment by using 6-thioguanine as a nanostructure lipid carrier (TG-NLCS). This was accomplished by administering an effective and targeted dose of 6-thioguanine (TG) to the tumour site using a long-lasting and biodegradable delivery system.\u0000Methods: A combination of heat homogenization and ultrasonication was used to implement the emulsification process. To obtain the optimal formulation, the prepared formulations were first assessed for particle size, Polydispersity Index (PDI), zeta potential, entrapment efficiency, and drug loading capacity. Additionally, a range of physicochemical characterization techniques were employed, including dissolution studies, melting point determination, Fourier-Transform Infrared (FTIR) spectroscopy, and Field Emission Scanning Electron Microscopy (FESEM), as well as cytotoxicity assessment of TG-NLCs in MCF-7 breast cancer cells.\u0000Results: The selected formula, TG03, showed a zeta potential of-13.5±0.27 mV and a particle size of 149±0.55 nm. This was further examined using a FESEM. In the in vitro drug release study, the formula demonstrated better-controlled drug release for 48 h in comparison to other formulations. In addition, the significant anti-proliferation activity of TG-NLCs against the MCF-7 breast cancer cell line.\u0000Conclusion: Nanostructured lipid carriers (NLCs) are one type of multifunctional nanoparticle that includes many combinations of lipids and medicines for various delivery routes.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003828","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":"AN UPDATED REVIEW OF STEALTH LIPOSOMES AND ITS ABILITY TO EVADE THE IMMUNE SYSTEM: A NEW FRONTIER IN CANCER CHEMOTHERAPY","authors":"Durgaramani Sivadasan","doi":"10.22159/ijap.2024v16i3.50601","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50601","url":null,"abstract":"Liposomes have been the delivery of choice for the cancer targeting therapy for the last few decades. Since the 1990s, the development of sterically stabilized (stealth) liposomes has garnered interest for their long circulating half-life. PEGylated (Polyethylene Glycol) liposomes are most extensively studied for delivering cancer therapeutics in a sustained manner. Stealth liposomes are having a less intrinsic toxicity with higher efficacy in cancer treatment. There are numerous clinical trials on the liposomes in tackling cancer is evident for the better outcome of the delivery system. Stealth liposomes are extensively studied for their improved circulation time and better pharmacokinetic profile in cancer treatment. The steric hindrance of the stealth liposomes bypasses the reticuloendothelial system clearance. Further the ligands conjugation in the surface of the liposomes able to achieve better target to the cancer cells. The vascularization nature of the cancerous cells is readily making the liposomal delivery of the cancer drugs accumulate in the cancerous cells rather than healthy cells. There is an utmost need to understand the possible mechanism of stealth liposomes and the basic science behind the development of liposomal delivery system in advancing the cancer treatment with less toxicity. The present review addresses the various modalities of the liposomal development, liposome characterization, mechanism of PEGylated liposomes, the advancements and results of the liposomes in the treatment of various diseases, and the clinical trials and regulatory considerations of liposomal drug delivery system.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"67 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003942","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}
Olga V. Levitskaya, T. Pleteneva, Daria A. Galkina, Nadezhda A. Khodorovich, E. Uspenskaya, Anton V. Syroeshkin
{"title":"CHIRAL SWITCHING CONTROL OF PHARMACEUTICAL SUBSTANCES","authors":"Olga V. Levitskaya, T. Pleteneva, Daria A. Galkina, Nadezhda A. Khodorovich, E. Uspenskaya, Anton V. Syroeshkin","doi":"10.22159/ijap.2024v16i3.50481","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50481","url":null,"abstract":"Objective: The aim of this study was to demonstrate that chiral switching should be recognized as a widespread phenomenon that extends beyond the production of pure enantiomeric drugs.\u0000Methods: To investigate the optical activity of substances from various chemical classes, enantiomers of chiral compounds (Sigma-Aldrich, USA) were chosen: valine and its racemic form (D-valine, L-valine, and racemic valine with optical purity ≥ 99%), L-ascorbic acid (content ≥ 99%), carbohydrates (D-glucose, D-galactose, L-galactose, contents ≥ 99.5%). Solutions were prepared using deuterium-depleted water (DDW–\"light\" water, D/H=4 ppm), natural deionized high-ohmic water (BD, D/H=140 ppm), and heavy water (99.9% D2O; Sigma-Aldrich). Optical activity was measured using the Atago POL-1/2 polarimeter.\u0000Results: One of the components in the racemic medication mixture can act as an inert agent, exhibit toxicity, or undergo undesirable biotransformation mechanisms, resulting in the formation of products with unknown properties. It has been established that a change in the deuterium/protium (D/H) ratio in water leads to a change in the equilibrium and kinetic characteristics of optically active compounds across various chemical classes, such as amino acids, carboxylic acids, and carbohydrates. An inequality was observed in the absolute values of the optical rotation of the L-and D-isomers of valine and galactose, depending on the D/H isotope ratio. The impact of chiral water clusters on optical rotation accounts for the sudden shift in the specific rotation of dilute solutions (less than 0.5%) of L-ascorbic acid in water, based on the D/H ratio. The influence of the isotopic composition of water was confirmed by studying the temperature-dependent mutarotation kinetics of D-glucose and L-and D-galactose in Arrhenius coordinates.\u0000The mutarotation process in natural high-resistivity water is characterized by an activation energy (Ea) of 40.8±1.4 kJ mol-1, while in deuterium-depleted water, Ea = 63.6±3.5 kJ mol-1. This results in a kinetic isotope effect for deuterium (KIED) of 1.6.\u0000Conclusion: Methodological approaches have been developed to control chiral switching based on the isotopic composition of water in vivo and in vitro. The study of changes in the optical activity of hierarchical structures in the human body, the influence of solvent properties on the mechanisms of optical rotation, as well as the use of KIED values, can be utilized to monitor various chiral transitions in vitro and living organisms.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"11 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141004000","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":"OSMOTIC DRUG DELIVERY SYSTEM OF NICORANDIL: DESIGN AND EVALUATION","authors":"Srilatha Choudhary, Cvs Subrahmanyam, K. Priyanka","doi":"10.22159/ijap.2024v16i3.50298","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50298","url":null,"abstract":"Objective: The purpose of the current research was to design a nicorandil formulation with controlled drug release using the principles of osmotic pump technology. Nicorandil is a biopharmaceutical classification system (BCS) class 3 drug, having a shorter plasma elimination half-life and bioavailability of 75 to 80%.\u0000Methods: The elementary osmotic pump (EOP) was prepared by coating a cellulose acetate polymer on the prepared core tablet. A 24-factorial design was applied to optimize the parameters for the osmotic tablet. A surface orifice was drilled.\u0000Results: Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and powder X-ray diffraction (PXRD) results showed that there was no interaction between drugs and excipients. A 24-factorial design was applied to optimize the parameters for the elementary osmotic pump. The optimized batch was characterized for in vitro drug release studies, and the effects of pH, osmotic pressure, and agitation intensity were analyzed. All the batches showed a drug release ranging from 90.48% to 98.78% after 12 hours. There was no change in the drug release pattern at different pHs and agitation intensities. The drug release was found to decrease with the increasing osmotic pressure of the dissolution medium. The results showed that the amounts of sodium chloride and mannitol were positively affecting the drug release, while the plasticizers PEG400 and DBP were not critical. Scanning electron microscopic studies (SEM) showed the integrity and surface morphology of the coating membrane before and after dissolution. The prepared EOP was found to deliver nicorandil at zero-order for up to 12 hours.\u0000Conclusion: Nicorandil was developed successfully as a controlled drug delivery during a 12-hour period, with variables optimized by the use of a 24-factorial design.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"7 20","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141005058","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":"THE APPLICATION OF BIOANALYTICAL METHOD OF TAMOXIFEN AND ITS ACTIVE METABOLITES FOR THERAPEUTIC DRUG MONITORING IN BREAST CANCER PATIENTS: A REVIEW","authors":"Muhammad Ikhsan, Y. Harahap","doi":"10.22159/ijap.2024v16i3.49957","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.49957","url":null,"abstract":"Breast cancer is the most common cancer around the world and in Indonesia. The most widely used agent for breast cancer treatment is tamoxifen, with a fixed dose of 20 mg per day. Tamoxifen is metabolized by cytochrome P450 3A4 (CYP3A4) and 2D6 (CYP2D6) to endoxifen and 4-hydroxytamoxifen, which have 30-to 100-fold more potent antiestrogenic activity than tamoxifen. High variations of CYP3A4 and CYP2D6 genes can lead to interpatient variability in its metabolites concentration. The dose can be increased to 40 or 60 mg per day based on individual needs. Therapeutic drug monitoring (TDM) is required to measure the concentration of tamoxifen and its metabolites to decide the individualized dose. The measurement of drug levels should use a sensitive, selective, accurate, precise, and reliable bioanalytical method. Various bioanalytical methods have been developed in several matrices: urine, scalp hair, serum, plasma, dried blood spot (DBS), and volumetric absorptive microsampling (VAMS) samples, with different sample preparations, and frequently using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The bioanalytical method of tamoxifen and its metabolites in the DBS sample was more suitable in the TDM application due to the low invasive sampling technique, more stable sample, and rapid sample preparation. Therefore, it is more time-and cost-efficient than the other methods.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"131 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141002139","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":"DESIGN AND OPTIMIZATION OF ESCITALOPRAM OXALATE ORAL DISSOLVING FILMS BY RESPONSE SURFACE METHODOLOGY","authors":"Chennupati Venu Babu, Venkata Ramana MURTHY KOLAPALLI","doi":"10.22159/ijap.2024v16i3.49662","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.49662","url":null,"abstract":"Objective: To develop and optimise the oral dissolving films of escitalopram oxalate by response surface methodology.\u0000Methods: Oral dissolving film compositions were optimized by central composite design. The films are prepared by solvent casting method. Initially, different polymers were screened and based on the results polyvinyl alcohol was selected as polymer, propylene glycol was selected as plasticizer. Concentration of polymer and concentration of plasticizer were fixed as independent variables; tensile strength, percent elongation, elastic modulus and amount dissolved up to 5 min (%D5 min) were taken as responses.\u0000Results: The prepared films exhibited good surface characteristics. The thickness, uniformity of weight, surface pH and drug content are within acceptable range. The mechanical properties like tensile strength, folding endurance, percent elongation and elastic modulus were determined. The statistical analysis showed that polymer concentration has a positive effect on disintegration time and the plasticizer concentration has a significant effect on folding endurance. The prepared film relesases nearly 95% at the end of 5 min. The design space was used to optimize the quantities of polymer and plasticizer. The comparison of checkpoint experiment batch responses are corelating with the predicted responses.\u0000Conclusion: Escitalopram oxalate oral dissolving films was successfully designed and optimized by response surface method. It was concluded that the prepared films exhibit good mechanical properties and maximum release within 10 min.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"2 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003923","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}