International Journal of Applied Pharmaceutics最新文献

{"title":"REVOLUTIONIZING THERAPEUTIC DELIVERY: DIOSGENIN-LOADED SOLID LIPID NANOPARTICLES UNLEASH ADVANCED CARRIERS","authors":"Ramsha Aslam, V. Tiwari, Prashant Upadhyay, Abhishek Tiwari","doi":"10.22159/ijap.2024v16i1.49306","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49306","url":null,"abstract":"Objective: The pharmaceutical industry has paid a lot of attention to solid lipid nanoparticles (SLN) because they show promise as drug delivery vehicles. The purpose of this research was to create and characterize SLN loaded with Diosgenin.\u0000Methods: To create SLN, the natural bioactive component diosgenin was encapsulated in a solid lipid matrix of compritol ATO 888. A modified solvent emulsification-evaporation process was used to create the SLN. Using a Box-Behnken Design (BBD), we were able to identify the optimal values for the drug-to-solid lipid ratio, surfactant concentration, and ultrasonication period that constitute an effective formulation.\u0000Results: It was found that the improved formulation had particle sizes of 170.96 nm, polydispersity indices (PDI) of 0.231, and entrapment efficiencies of 64.549±0.553% %. The zeta potential value of -40.2 mV was indicative of a steady dispersion. The average particle size of the SLN was measured to be 103.1429 nm, and their spherical morphology was validated by scanning electron microscopy (SEM) imaging. The optimized formulation did not undergo any chemical changes, as shown by differential scanning calorimetry (DSC) testing. The in vitro drug release investigation showed that the SLN released Diosgenin continuously for 28 h.\u0000Conclusion: The optimized formulation of SLN, achieved through the BBD, offers a promising strategy to improve drug solubility while ensuring controlled drug release and long-term storage stability.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"68 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139449126","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":"NOVEL BIOMATERIAL ASSISTED DRUG DELIVERY SYSTEMS FOR THE MANAGEMENT OF ORAL DISEASES–FUTURE THERAPEUTIC APPROACHES","authors":"Mridula R. Chandran, R. Usha","doi":"10.22159/ijap.2024v16i1.49448","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49448","url":null,"abstract":"Oral health is integral to maintaining systemic health as the mouth and oral cavity connect our digestive system with the external environment. The incidence of oro-dental disorders has been emerging as a serious threat to the healthcare sector owing to the increasing complexity of oral microbiome. Conventional treatment modalities are often limited by drug resistance and unwanted inflammatory responses. Recently, therapeutic strategies that can reinstate microbial homeostasis in the oral microenvironment have been implicated in the management of odontogenic infections. Biomaterial-based drug delivery systems, including nanocarriers, dendrimers, hydrogels, oral thin films, oral patches, and other stimuli-responsive polymeric systems, facilitate targeted administration of antimicrobials and anti-inflammatory agents to the site of infection. Bio adhesivity of the polymeric carriers facilitates faster disintegration and accurate dosing of the pharmacological agent to the target site. Moreover, restorative dentistry has been revolutionized by the advent of bio-functional templates that offer improved osseointegration and long-term stability of implants. A comprehensive review of the potential applications of biomaterial-mediated therapeutic strategies in the management of caries, peri-implantitis, periodontitis, and other oro-dental infections is explored here.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"67 35","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139449186","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 SIMULTANEOUS QUANTIFICATION OF RIFAMPICIN AND ISONIAZID IN PATIENTS WITH TUBERCULOSIS APPLIED TO VOLUMETRIC ABSORPTIVE MICROSAMPLING DEVICES USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY","authors":"Hema Novita Rendati, Y. Harahap, Rahmayanti","doi":"10.22159/ijap.2024v16i1.49108","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49108","url":null,"abstract":"Objective: Rifampicin and isoniazid are the main tuberculosis treatment regimens requiring blood level measurement to optimize the treatment process. This study aims to analyze rifampicin and isoniazid quantitatively in volumetric absorptive microsampling (VAMS) prepared from a small volume of TB patients using HPLC.\u0000Methods: Analytes on the VAMS tip were extracted using 1000 ml of acetonitrile containing 10 µg/ml of cilostazol as an internal standard. Analytical separation was performed on the C-18 column at 40 ℃ with a mobile phase mixture of 50 mmol ammonium acetate buffer pH 5.0-acetonitrile-methanol (40:30:30), flow rate 0.5 ml/min. The analysis was carried out with the calibration curve over a range of 1.0–30 µg/ml for rifampicin and 0.4-20 µg/ml for isoniazid.\u0000Results: Analyte analysis in 21 patients showed that the measured value of rifampicin was 3.39–16.77 µg/ml, and isoniazid was 2.63–10.43 µg/ml at 2 h post-dose. 52.38% of patients had low blood concentrations in at least one of the drugs, 28.57% of the patients were in the therapeutic range, and 23.81% had a high blood concentration of isoniazid alone.\u0000Conclusion: The concentration of rifampicin and isoniazid in 21 tuberculosis patients varied. Dose adjustment is needed because most patients had low blood concentrations of one of the drugs, and a limited number had a high blood isoniazid concentration alone. Only some patients simultaneously had plasma concentrations within the target range of the drugs. This method was valid and reliably utilized for therapeutic drug monitoring of antituberculosis.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"35 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448106","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, CHARACTERIZATION AND EVALUATION OF MYRICETIN-LOADED NANOEMULSION FOR THERAPEUTIC EFFICACY IN WOUND HEALING","authors":"Tanvir Y. Shaikh, S. Lodhi","doi":"10.22159/ijap.2024v16i1.49112","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49112","url":null,"abstract":"Objective: Aim of the present study was the development, optimization and evaluation of myricetin-loaded nanoemulsion gel for wound healing.\u0000Methods: Myricetin nanoemulsion was prepared by selecting Peanut oil as oil (wt %), Tween 20 and Polyethylene glycol 400 as surfactant and cosurfactant (Smix) and aqueous phase water. Performance of nanoemulsion gel was evaluated by wound healing activity tested against wound contraction, hydroxyproline content, protein content and antioxidant assay.\u0000Results: The optimized nanoemulsion (NEF1) exhibited appreciable stability concerning droplet size and PDI when stored at 5 ᵒC, 25 ᵒC and 40ᵒC up to three months. Morphological characterization by TEM indicated a spherical shape. Wound healing effect was observed through a significant (p<0.5) increase in hydroxyproline content, protein content and antioxidant status in wound tissue. The level of superoxide dismutase (SOD) and catalase were found to increase significantly in wound tissue after treatment with Myricetin loaded nanoemulsion (MYCT-NE) gel, as well as results were comparable to Betadine cream.\u0000Conclusion: In conclusion, MYCT-NE gel was found potent wound healing effect through the reduction of oxidative stress and epithelialization of tissue.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"23 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448769","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 BIOPHARMACEUTICAL EVALUATION OF SUSTAINED RELEASE PELLETS OF BOSENTAN BY PANCOATING METHOD","authors":"G. Reddy, P. V, R. P., Ramarao Nadendla","doi":"10.22159/ijap.2024v16i1.49039","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49039","url":null,"abstract":"Objective: The aim of the present study was to formulate sustained-release pellets of bosentan by eudragit RL 100 and RS 100, which are the polymers used in the pan coating technique.\u0000Methods: The sustained release pellets of bosentan were formulated by pan coating method. The drug was coated on nonpareil seeds along with EudragitRL100 by solution layering technique. Drug-loaded pellets were coated with EudragitRS100. The prepared pellets were evaluated for moisture content, drug content, particle size, and in vitro drug release. Stability studies were carried out on the optimised formulations for a period of 6 mo.\u0000Results: The drug content was in the range of 98.89±0.32. The mean particle size of the drug-loaded pellets was in the range of 835 μm. The drug release rate decreased as the concentration of eudragit increased in the pellet formulations. Among the prepared formulations, PC 4 showed 89.35±0.52 drug release in 12 h from a good linear relationship was established between model-independent approaches (T25%, T50%, and T100%) and weight gain in coating. This indicated the possibility of extending the drug release by increasing the weight gain in the coating, and hence, it was proposed to extend the drug release for 24 h. From the prepared pellets, the optimised formulation PC 12 showed a 100.02±0.03 drug release in 24 h. Furthermore, these pellets were filled into capsules and compared the dissolution studies. The compatibility between drugs and polymers in the drug-loaded pellets was confirmed by DSC and FTIR studies. Stability studies indicated that the pellets were stable.\u0000Conclusion: The prepared pellets were capable of releasing the drug for 24 h to treat the Pulmonary Arterial Hypertension.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"23 25","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448715","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":"MODIFIED CYCLODEXTRIN-BASED THERMOSENSITIVE IN SITU GEL FOR VORICONAZOLE OCULAR DELIVERY AGAINST FUNGAL KERATITIS","authors":"S. Sampathi, S. Maddukuri, Ramdas Ramavath, S. Dodoala, V. Kuchana","doi":"10.22159/ijap.2024v16i1.48817","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.48817","url":null,"abstract":"Objective: Fungal keratitis is a severe corneal infection. The present study aims to design and formulate an inclusion complex of Voriconazole-Sulfobutyl ether-beta-cyclodextrin (V-SBECD) loaded thermosensitive in-situ gel to improve solubility, therapy efficacy, durability and reduce the dose-related side effect.\u0000Methods: Poloxamer 407, a thermosensitive polymer along with hydroxypropyl methylcellulose (HPMC E 15), were used as gelling agents; the formulations with poloxamer (16% w/v) and HPMC E15 (1 and 1.5 % w/v) led to a consistent in-situ gel at 37 °C. The formulations were evaluated for drug content, pH, gelation temperature, viscosity, sterility test, antifungal studies, and cell lines studies.\u0000Results: The molar ratio of the drug to SBECD (1:3), showing 42-fold increase in solubility, was chosen to prepare the inclusion complexes using the lyophilization method. The stability constant was found to be 721-m. ATIR peaks, DSC thermograms and NMR spectra indicate the inclusion behavior of Voriconazole and SBECD. In vitro and ex-vivo studies demonstrated that optimized formulation sustained the drug release for over 12 h. Cellular cytotoxicity on Human corneal epithelial cells showed that V-SBECD formulations do not cause corneal epithelial damage after 24 h. In-situ gel and marketed formulation have shown a markable reduction in the growth of the Aspergillus Niger. The optimized SBECD-loaded in-situ gel formulation (F10) did not vary significantly in pH, drug content, viscosity, and % cumulative drug release, signifying stable formulations when tested at 4, 25, and 40 °C.\u0000Conclusion: The research findings envisaged V-SBECD in-situ gel formulation as a concrete strategy to treat severe fungal keratitis.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"22 21","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448341","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":"INVESTIGATING THE TOXICITY OF BETALAIN COMPOUNDS: IN SILICO ANALYSIS AND IN VIVO PREDICTIONS FOR STANDARDIZED BETA VULGARIS L. EXTRACT","authors":"S. E. Nugraha, J. M. Keliat, R. A. Syahputra, Sony Eka, Nugraha","doi":"10.22159/ijap.2024v16i1.49189","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49189","url":null,"abstract":"Objective: Extensive research has been conducted on beetroot's antioxidant, hematoprotective, and cardioprotective properties. However, there currently needs to be more available evidence pertaining to the toxicity assessment of the extract. The toxicity assessment was conducted using both in silico and in vivo methods. Prior to testing, the extracts were standardized in accordance with the guidelines set by the Indonesian Food Drug Authority (BPOM), which is the regulatory authority for food and drugs in Indonesia.\u0000Methods: The experimental subjects consisted of 25 male Wistar rats in good health, weighing between 150 and 170 grams. These rats were separated into five groups, each including five rats. Group 1 will serve as the control group, while groups 2 through 5 will be designated as the treatment groups. The analysis of chemical toxicity was conducted using pK-CSM, SwissADME, and Pro-Tox II methodologies.\u0000Results: The results indicated that the standardized ethanol extract contained 4.341% water, 3.67 % total ash, and 1.53 % acid-insoluble ash. Lead (Pb) and cadmium (Cd) were absent at a concentration of 0 parts per million (ppm). Subsequently, the total plate count and yeast mould count were 0.47 5 x 10-4 (CFU/g) and a of 0.382 x 10-4 (CFU/g) respectively. This finding implies that the extract meets BPOM requirement. This study also measured the betalain content of red beetroot, yielding a total concentration of 11.34 0.37 mg/100 gram of sample. Haematological experiments showed that beetroot extract affected rat blood haematology. Compared to the control group, rats given the extract had higher red blood cell and platelet counts. Additionally, the Insilico toxicity test conducted on the active component derived from beetroot revealed LD50 of the compounds ranged from 305 mg/kg so that were categorized into classes IV and presence of hepatotoxic potential. During the in vivo experiment, there has been a notable rise in hepatic and renal parameters. Furthermore, one mortality event occurred in the test subject at a 5,000 mg/kg body weight dosage.\u0000Conclusion: Single oral administration of the extract at a dose larger than 5,000 mg per kilogram of body weight does not result in lethal effects, however showed potential toxicity to the liver.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"12 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448729","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":"LIGAND-BASED VIRTUAL SCREENING OF FDA-APPROVED DRUGS TO IDENTIFY NEW INHIBITORS AGAINST LACTATE DEHYDROGENASE ENZYME OF MALARIA PARASITES","authors":"H. Odhar, Ahmed Fadhil Hashim, S. Humadi, S. Ahjel","doi":"10.22159/ijap.2024v16i1.49382","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49382","url":null,"abstract":"Objective: The aim of this study is to computationally repurpose FDA-approved drugs as potential inhibitors of the Plasmodium falciparum lactate dehydrogenase (PfLDH) by competing with the cofactor NADH.\u0000Methods: In this in silico study, we have virtually screened a library of FDA-approved drugs for structural similarity to the dihydro nicotinamide adenine dinucleotide (NADH). Then, the top hits were further assessed for clinical safety and by application of molecular docking and dynamics simulation.\u0000Results: Ligand-based virtual screening reports that the antibiotic Novobiocin has a good similarity to the cofactor NADH with a score of 0.7. Also, molecular docking study indicates that Novobiocin may has the ability to interact with PfLDH enzyme with a docking energy of-8.8 Kcal/mol. However, during molecular dynamics (MD) simulation, the mean ligand proximity root mean square deviation (RMSD) and binding energy for Novobiocin were 4.3 Angstrom and-37.45 Kcal/mol, respectively. These MD simulation parameters are inferior to those recorded for NADH molecule during 50 nanosecond intervals.\u0000Conclusion: The antibiotic Novobiocin may serve as a potential lead candidate toward the design of novel antimalarial agents. However, further evaluation of Novobiocin may be recommended to affirm its capacity against PfLDH enzyme.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"34 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448217","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":"NANOPARTICLE PREPARATION OF SIAM CITRUS PEEL EXTRACT (CITRUS NOBILIS L. VAR. MICROCARPA) USING SHORT-CHAIN CHITOSAN AND TRIPOLYPHOSPHATE AS CROSS LINKER AND CELLULAR UPTAKE STUDY ON MCF-7 CELL LINE BY IN VITRO","authors":"Wintari Taurina, Mohamad Andrie","doi":"10.22159/ijap.2024v16i1.49487","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49487","url":null,"abstract":"Objective: High consumption of oranges causes a lot of orange peel waste. Orange peel contains the compound naringenin, which has a cytotoxic effect on various cancer cells. This research aims to develop a preparation of Siamese orange peel extract nanoparticles with short-chain chitosan and tripolyphosphate carriers as an oral drug delivery system and determine its cytotoxic activity against the Michigan Cancer Foundation-7 (MCF-7) cell line.\u0000Methods: This research uses the micro tetrazolium (MTT) method to see the cytotoxic activity extract of methanol obtained from maceration extraction. The extract was then formulated into nanoparticles using chitosan and tripolyphosphate. Characterization and evaluation of nanoparticles were carried out, including particle size, zeta potential, entrapment efficiency, and stability in the stomach using 0.1 N HCl and in the intestine using Artificial Intestinal Fluid (AIF) in vitro. This research was also conducted to assess the ability of nanoparticles to enter MCF-7 cells (cellular uptake).\u0000Results: Nanoparticles were successfully developed from Siamese orange peel extract. The results of the day 0 nanoparticle characterization were spherical, with average particle size 284.3 nm, zeta potential 0.713 mV, entrapment efficiency 96.73%, and stability in 0.1 N HCl at the 0th hours, respectively. 1st, 2nd, and 3rd. 99.16%, 98.70%, 98.47%, 98.31%, stability on AIF at hours 0, 1, 2, 3 and 4 respectively 99.52%, 99.30%, 99.40%, 98.99%, 99.29%. Characterization of nanoparticles on day 25 showed that the average particle size was 196.2 nm, zeta potential 0.476 mV, entrapment efficiency 96.92%, stability in 0.1 N HCl at 0, 1, 2 and 3 h respectively 99.51%, 98.67%, 98.51%, 98.27%, stability in AIF at 0th, 1st, 2nd, 3rd, and 4th hours 99.24 respectively %, 98.76%, 98.46%, 97.93%, 97.58%. Cytotoxic activity of extract Siamese citrus peel against MCF-7 cells with IC50 of 290.58 µg/ml. The result shows that cellular uptake of Siamese citrus peel nanoparticles can penetrate MCF-7 cells.\u0000Conclusion: Stable nanoparticles were successfully developed from Siamese orange peel extract, and their stability was maintained throughout a 30-day storage period. This extract displayed cytotoxic effects and showcased the ability for cellular uptake in MCF-7 cell cultures in vitro.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"33 20","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448381","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":"BI-LAMINATED ORAL DISINTEGRATING FILM FOR SYMPTOMATIC TREATMENT OF VIRAL NASOPHARYNGITIS: FORMULATION, CHARACTERIZATION, TASTE MASKING, AND STABILITY STUDIES","authors":"Merna A. Rizk, M. Teaima, Rehab Abdelmonem, M. EL-NABARAWI, S. F. Elhabal","doi":"10.22159/ijap.2024v16i1.49499","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i1.49499","url":null,"abstract":"Objective: Nasopharyngitis (NP) is one of the most common upper respiratory tract infections (URTIs) brought on by viral infections and requires symptomatic treatment. In this study, a new approach to delivering drugs was developed, which is a bi-laminated oral disintegrating film (ODF) containing dextromethorphan hydrobromide (DEX), phenylephrine hydrochloride (PE), and methylcobalamin (MeCbl) to support the symptomatic treatment of NP. Yet, the extreme bitterness of DEX and PE required a taste-masking technique before ODF formulation to enhance patient compliance.\u0000Methods: Various complexing agents were tried at different ratios to mask the bitter taste of the drug(s). DEX-PE ODFs were formulated using the solvent casting procedure. A 31.21 full factorial design was performed to characterize DEX-PE ODFs, where the effects of polymer grade and plasticizer type were evaluated on the disintegration time (DT) and the percentage of drugs released after 10 min (Q10).\u0000Results: Complexation with maltodextrin (MD) and ion exchange resin (Kyron T-314) could successfully mask the bitter taste at a ratio of 1:2:2 of drugs, MD, and Kyron T-314, respectively. The ODF optimized formula (F4) recorded the least DT (5±0.5 s) and highest Q10 (96.7±2.1%) and (97.4±1.9%) for DEX and PE, respectively. F4 was then combined with the second film layer containing MeCbl to develop the bi-laminated ODF (B1), which was later evaluated and subjected to stability studies.\u0000Conclusion: In conclusion, a taste-masked, bi-laminated ODF could be successfully developed for the symptomatic treatment of NP.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"26 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139448479","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}