Multiple three-component co-amorphous systems have been created via a melt- quench method. This has been confirmed by a single glass transition in the individual DSC traces and then reinforced by X-ray diffraction data, which show an absence of crystalline material. ATR-FTIR has also been used to show a change in bonding vibrations between the physical mixtures and co-amorphous samples. The change in bonding vibrations indicates different molecular interactions within the co-amorphous materials.
{"title":"The Use Of XRPD And ATR-FTIR In The Screening Of Three Component Co-amorphous Systems Created Via A Melt-Quench Method.","authors":"B. Edgar, A. D’Angelo, Milan D Antonjievic","doi":"10.5920/BJPHARM.2017.24","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.24","url":null,"abstract":"Multiple three-component co-amorphous systems have been created via a melt- quench method. This has been confirmed by a single glass transition in the individual DSC traces and then reinforced by X-ray diffraction data, which show an absence of crystalline material. \u0000ATR-FTIR has also been used to show a change in bonding vibrations between the physical mixtures and co-amorphous samples. The change in bonding vibrations indicates different molecular interactions within the co-amorphous materials.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88624166","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}
pH dependent hydrogel formulations of venlafexine HCl were prepared by free radical polymerization method using polyethylene glycol as polymer. Various samples were prepared with varying concentration of polymer, monomer and cross-linker to study their effect on gel swelling, diffusion characteristics and drug release. Swelling was found to be increased with increase in pH. Increase in acrylic acid concentration increases swelling while increase in cross-linker concentration has an opposite effect on swelling. Drug release study was performed in pH 1.2, 5.5 and 7.5 for 12 hours at 37 oC and drug release was found to increase in higher pH. Prepared hydrogel preparations were also characterized by PXRD, TGA, SEM and FTIR.
{"title":"Synthesis and evaluation of pH dependent hydrogels for controlled release of Venlafaxine HCl","authors":"N. Abbas, Q. Ijaz, A. Hussain, N. Bukhari","doi":"10.5920/BJPHARM.2017.30","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.30","url":null,"abstract":"pH dependent hydrogel formulations of venlafexine HCl were prepared by free radical polymerization method using polyethylene glycol as polymer. Various samples were prepared with varying concentration of polymer, monomer and cross-linker to study their effect on gel swelling, diffusion characteristics and drug release. Swelling was found to be increased with increase in pH. Increase in acrylic acid concentration increases swelling while increase in cross-linker concentration has an opposite effect on swelling. Drug release study was performed in pH 1.2, 5.5 and 7.5 \u0000for 12 hours at 37 oC and drug release was found to increase in higher pH. Prepared hydrogel preparations were also characterized by PXRD, TGA, SEM and FTIR.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"109 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80660273","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}
Indomethacin and piroxicam are known to become amorphous upon rapid cooling after melting. Multiple three-component co-amorphous mixtures have been produced via a melt quench method to evaluate the influence of the third component on stability and physical properties on the co-amorphous mixture of piroxicam and indomethacin. These have then been tested using thermal gravimetric analysis, differential scan calorimetry and hot stage microscopy. Results have confirmed the creation of a three-component co-amorphous system.
{"title":"The Utilisation Of Thermal Methods For The Screening Of Three Component Co-amorphous Systems","authors":"A. D’Angelo, B. Edgar, M. Antonijević","doi":"10.5920/BJPHARM.2017.21","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.21","url":null,"abstract":"Indomethacin and piroxicam are known to become amorphous upon rapid cooling after melting. Multiple three-component co-amorphous mixtures have been produced via a melt quench method to evaluate the influence of the third component on stability and physical properties on the co-amorphous mixture of piroxicam and indomethacin. These have then been tested using thermal gravimetric analysis, differential scan calorimetry and hot stage microscopy. Results have confirmed the creation of a three-component co-amorphous system.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"164 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86202635","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}
A library of dienones were synthesized as candidate antifungal agents. These compounds were screened against Saccharomyces cerevisiae and Candida albicans using macro-broth susceptibility assay. The dienones exhibited a broad range of inhibition against S. cerevisiae (0.2-99%) and C. albicans (0-99%). 3,5-bis(p- trifluoromethylbenzylidene)-1-methyl-piperidine-4-one was identified as the most potent inhibitor of S. cerevisiae. Whereas, the most promising inhibitor of C. albicans was 2,6-bis(pyridine-3ylmethylene)cyclohexan-1-one.
{"title":"Synthesis and evaluation of novel antifungal agents targeted to the plasma membrane H[+]-ATPase","authors":"D. Patel, J. Bassin, D. G. Griffiths","doi":"10.5920/BJPHARM.2017.28","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.28","url":null,"abstract":"A library of dienones were synthesized as candidate antifungal agents. These compounds were screened against Saccharomyces cerevisiae and Candida albicans using macro-broth susceptibility assay. The dienones exhibited a broad range of inhibition against S. cerevisiae (0.2-99%) and C. albicans (0-99%). 3,5-bis(p- trifluoromethylbenzylidene)-1-methyl-piperidine-4-one was identified as the most potent inhibitor of S. cerevisiae. Whereas, the most promising inhibitor of C. albicans was 2,6-bis(pyridine-3ylmethylene)cyclohexan-1-one.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91293868","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}
N. Abbas, A. Hussain, Muhuammad Ahsan Hafiz, Kausar Perveen
Fluconazole (an antifungal drug) loaded nanosponges (NS) were prepared by an emulsion solvent diffusion method using ethyl cellulose as the polymer. Prepared formulations were evaluated for various physicochemical parameters and in-vitro drug release. NS of fluconazole were discrete, free flowing nanosized particles with perforated orange peel-like morphology as shown by SEM analysis. A topical hydrogel formulation based on the drug loaded NS showed a prolonged release profile for the drug. Kinetic modelling on release data showed that the best fitted model was Higuchi model and release mechanism was by Fickian diffusion. FTIR and PXRD results confirmed the absence of any drug polymer interaction and stability of drug in the delivery system.
{"title":"Formulation and evaluation of fluconazole loaded nanospongies for improved topical drug delivery","authors":"N. Abbas, A. Hussain, Muhuammad Ahsan Hafiz, Kausar Perveen","doi":"10.5920/bjpharm.2017.29","DOIUrl":"https://doi.org/10.5920/bjpharm.2017.29","url":null,"abstract":"Fluconazole (an antifungal drug) loaded nanosponges (NS) were prepared by an emulsion solvent diffusion method using ethyl cellulose as the polymer. Prepared formulations were evaluated for various physicochemical parameters and in-vitro drug release. NS of fluconazole were discrete, free flowing nanosized particles with perforated orange peel-like morphology as shown by SEM analysis. A topical hydrogel formulation based on the drug loaded NS showed a prolonged release profile for the drug. Kinetic modelling on release data showed that the best fitted model was Higuchi model and release mechanism was by Fickian diffusion. FTIR and PXRD results confirmed the absence of any drug polymer interaction and stability of drug in the delivery system.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85868546","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}
Raman microscopy was used to visualize the integrity of a barrier membrane coating at the various stage of chewable tablets development. The effect of substrate morphology and particle characteristics was found to be important in maintaining the integrity of the coating throughout the process of chewable tablets manufacture. Furthermore, the observations from the Raman image analysis provide an understanding of the factors affecting drug release.
{"title":"Understanding the Integrity of Coating for Taste-Masked Granules – Before and After Tablet Compression","authors":"M. Ghimire","doi":"10.5920/BJPHARM.2017.17","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.17","url":null,"abstract":"Raman microscopy was used to visualize the integrity of a barrier membrane coating at the various stage of chewable tablets development. The effect of substrate morphology and particle characteristics was found to be important in maintaining the integrity of the coating throughout the process of chewable tablets manufacture. Furthermore, the observations from the Raman image analysis provide an understanding of the factors affecting drug release.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88971751","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}
This study aimed to develop xerogels for delivery of aspirin via the oral (buccal mucosa and GIT) route in geriatric patients with dysphagia. Xerogels were prepared using low molecular weight chitosan (CS), carrageenan (CAR) and metolose (MET) in different ratios, loaded with aspirin (75 mg). Gels (2.5% w/v and 4.0% w/v) were prepared (60 °C) using 40% v/v ethanol and freeze dried for 48 hours. Xerogels (2.5% w/v MET: CAR 3:1 and 1:1, 4.0% CAR: CS 1:3 and 1:1 and 4.0% MET: CS 1:3 gels) were characterised with texture analysis (TA) for hardness and mucoadhesion, swelling index (%) and porosity (%) to identify an optimised formulation for controlled release (buccal) and fast release (GIT) delivery. Scanning electron microscopy (SEM) was used to assess surface morphology and X-ray diffraction (XRD) to assess the physical form of the formulations (amorphous or crystalline). Xerogels from 2.5 % w/v MET: CAR 3:1 and 1:1 gels showed higher swelling capacity (%) (more than 2 hours to disintegrate) and can be applied to the buccal mucosa for controlled delivery of the API while 4.0 % w/v CAR: CS 1:3 and 1:1 can be used as rapid release xerogel (disintegrated within 2 minutes) for oral GIT delivery.
{"title":"Aspirin loaded xerogels for buccal and oral GIT delivery for patients with dysphagia to target deep vein thrombosis","authors":"Smirna Farias","doi":"10.5920/BJPHARM.2017.18","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.18","url":null,"abstract":"This study aimed to develop xerogels for delivery of aspirin via the oral (buccal mucosa and GIT) route in geriatric patients with dysphagia. Xerogels were prepared using low molecular weight chitosan (CS), carrageenan (CAR) and metolose (MET) in different ratios, loaded with aspirin (75 mg). Gels (2.5% w/v and 4.0% w/v) were prepared (60 °C) using 40% v/v ethanol and freeze dried for 48 hours. Xerogels (2.5% w/v MET: CAR 3:1 and 1:1, 4.0% CAR: CS 1:3 and 1:1 and 4.0% MET: CS 1:3 gels) were characterised with texture analysis (TA) for hardness and mucoadhesion, swelling index (%) and porosity (%) to identify an optimised formulation for controlled release (buccal) and fast release (GIT) delivery. Scanning electron microscopy (SEM) was used to assess surface morphology and X-ray diffraction (XRD) to assess the physical form of the formulations (amorphous or crystalline). Xerogels from 2.5 % w/v MET: CAR 3:1 and 1:1 gels showed higher swelling capacity (%) (more than 2 hours to disintegrate) and can be applied to the buccal mucosa for controlled delivery of the API while 4.0 % w/v CAR: CS 1:3 and 1:1 can be used as rapid release xerogel (disintegrated within 2 minutes) for oral GIT delivery.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78531025","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}
E. Angelis, L. Immins, N. Jibry, D. Hunt, K. Cheng, P. Chowdhury, C. Patel, S. Wilhelm, P. Williams
In 2012, the United Nations (UN), identified chlorhexidine as a Life-saving Commodity and called for the development of a chlorhexidine product suitable for the prevention of omphalitis (umbilical cord infection) in developing countries. In response, GlaxoSmithKline (GSK) set out to develop a chlorhexidine digluconate 7.1% w/w gel, in partnership with Save the Children. The vision was to develop a gel which could pass a stringent regulatory review thereby assuring a safe, effective, and quality product. Review under the European Medicines Agency’s (EMA) Article 58 pathway was pursued, with accelerated assessment granted. The regulatory dossier compiled literature-based evidence for clinical efficacy and safety, supplemented by GSK-generated in-vitro studies and a full CMC data package to support the quality. No new clinical trial data or in vivo non-clinical study data were submitted. A positive opinion from the EMA was received in 2016. The time from the initial UN call to EMA Positive Opinion was 3 years and 7 months.
2012年，联合国将氯己定确定为拯救生命的商品，并呼吁开发一种适合预防发展中国家脐带感染的氯己定产品。为此，葛兰素史克(GSK)与救助儿童会(Save the Children)合作，开始开发一种7.1% w/w的二光酸氯己定凝胶。愿景是开发一种凝胶，可以通过严格的监管审查，从而确保安全，有效和高质量的产品。根据欧洲药品管理局(EMA)第58条途径进行了审查，并批准了加速评估。监管档案汇编了基于文献的临床疗效和安全性证据，并辅以gsk生成的体外研究和完整的CMC数据包来支持质量。未提交新的临床试验数据或体内非临床研究数据。2016年收到了EMA的积极意见。从最初的联合国呼吁到EMA的积极意见的时间是3年零7个月。
{"title":"Enabling an Accelerated Development Path for Chlorhexidine Digluconate Gel 7.1% w/w for the Prevention of Omphalitis","authors":"E. Angelis, L. Immins, N. Jibry, D. Hunt, K. Cheng, P. Chowdhury, C. Patel, S. Wilhelm, P. Williams","doi":"10.5920/BJPHARM.2017.31","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.31","url":null,"abstract":"In 2012, the United Nations (UN), identified chlorhexidine as a Life-saving Commodity and called for the development of a chlorhexidine product suitable for the prevention of omphalitis (umbilical cord infection) in developing countries. In response, GlaxoSmithKline (GSK) set out to develop a chlorhexidine digluconate 7.1% w/w gel, in partnership with Save the Children. The vision was to develop a gel which could pass a stringent regulatory review thereby assuring a safe, effective, and quality product. Review under the European Medicines Agency’s (EMA) Article 58 pathway was pursued, with accelerated assessment granted. The regulatory dossier compiled literature-based evidence for clinical efficacy and safety, supplemented by GSK-generated in-vitro studies and a full CMC data package to support the quality. No new clinical trial data or in vivo non-clinical study data were submitted. A positive opinion from the EMA was received in 2016. The time from the initial UN call to EMA Positive Opinion was 3 years and 7 months.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"223 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76290904","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}
N. Malek, Irina Ermonlina, V. Khutoryanskiy, E. Hackl
The aim of this work was the manufacture and characterisation of novel chemically cross-linked mucoadhesive PVA-GANT hydrogels prepared by using autoclaving. Particularly, the study was focused on the physicochemical and pharmaceutical properties of these hydrogels with regards to potential applications for drug delivery and wound dressing. PVA-GANT hydrogels with different molar ratios and total concentrations of polymers in solution were prepared using a standard sterilisation autoclave. The physico-chemical properties were characterised by various techniques including IR spectroscopy, Texture Analysis and SEM and thermo-analytical techniques (DSC and TGA). Pharmaceutical characteristics were obtained in drug loading/release tests and microbiological assays. The results have shown that the properties of hydrogels (swelling degree, mechanical properties, internal structure, drug loading/release and antimicrobial properties) are very dependent on the polymer composition.
{"title":"Investigation of Physicochemical Properties of PVA-GANT Mucoadhesive Hydrogels","authors":"N. Malek, Irina Ermonlina, V. Khutoryanskiy, E. Hackl","doi":"10.5920/BJPHARM.2017.25","DOIUrl":"https://doi.org/10.5920/BJPHARM.2017.25","url":null,"abstract":"The aim of this work was the manufacture and characterisation of novel chemically cross-linked mucoadhesive PVA-GANT hydrogels prepared by using autoclaving. Particularly, the study was focused on the physicochemical and pharmaceutical properties of these hydrogels with regards to potential applications for drug delivery and wound dressing. PVA-GANT hydrogels with different molar ratios and total concentrations of polymers in solution were prepared using a standard sterilisation autoclave. The physico-chemical properties were characterised by various techniques including IR spectroscopy, Texture Analysis and SEM and thermo-analytical techniques (DSC and TGA). Pharmaceutical characteristics were obtained in drug loading/release tests and microbiological assays. The results have shown that the properties of hydrogels (swelling degree, mechanical properties, internal structure, drug loading/release and antimicrobial properties) are very dependent on the polymer composition.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88976478","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}
Drug delivery to the eye has always been an interesting and challenging field in pharmaceutical formulation and drug design. The aim of this research was the formulation development of thin erodible films for potential delivery of lopidine to treat glaucoma. Films were prepared using hyaluronic acid (HA) and hydroxypropyl methylcellulose (HPMC) as polymers, together with glycerol (GLY) as plasticiser. Single layer films were prepared using each polymer individually, as well as in combination to obtain composite thin films. Various combinations and concentrations were optimised to reach the desired transparency, which were then characterised for their physico-chemical and mechanical properties. The following ratios were selected for drug loading: 2% HPMC, 1% HA, 1% composite (HPMC 1:1 HA) and 2% composite (HPMC 1.5:0.5 HA) with all of them containing a ratio of 2:1 polymer to plasticiser.
{"title":"Erodible Film Formulation for Potential Ocular Drug Delivery","authors":"M. Tighsazzadeh, J. Boateng","doi":"10.5920/bjpharm.2017.23","DOIUrl":"https://doi.org/10.5920/bjpharm.2017.23","url":null,"abstract":"Drug delivery to the eye has always been an interesting and challenging field in pharmaceutical formulation and drug design. The aim of this research was the formulation development of thin erodible films for potential delivery of lopidine to treat glaucoma. Films were prepared using hyaluronic acid (HA) and hydroxypropyl methylcellulose (HPMC) as polymers, together with glycerol (GLY) as plasticiser. Single layer films were prepared using each polymer individually, as well as in combination to obtain composite thin films. Various combinations and concentrations were optimised to reach the desired transparency, which were then characterised for their physico-chemical and mechanical properties. The following ratios were selected for drug loading: 2% HPMC, 1% HA, 1% composite (HPMC 1:1 HA) and 2% composite (HPMC 1.5:0.5 HA) with all of them containing a ratio of 2:1 polymer to plasticiser.","PeriodicalId":9253,"journal":{"name":"British Journal of Pharmacy","volume":"98 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86079817","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}
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