Folate-conjugated chitosan nanoparticles represent a promising nanoplatform for targeted delivery of anticancer drugs. The nanoparticle carrier can protect the therapeutic agents from degradation and offer the ability to target cancer cells overexpressing folate receptors. This review summarizes recent research progress in synthesizing folate-conjugated chitosan nanoparticles as well as evaluating their potential as targeted drug delivery systems. The chemical conjugation of folic acid to chitosan is first discussed followed by an overview of different techniques for preparation of stable folate-conjugated chitosan nanoparticles less than 200 nm in size. Recent studies loading various anticancer drugs into these nanoparticles and investigating their in vitro cytotoxicity against multiple cancer cell lines are then summarized. The results indicate that folate-conjugated nanoparticles exhibit higher cytotoxicity and targeting efficiency compared to non-conjugated nanoparticles due to receptor-mediated endocytosis. Lastly, future challenges and opportunities are outlined including in vivo investigations to determine the effectiveness, toxicity, and pharmacokinetics of folate-conjugated chitosan nanoparticle systems as well as their potential clinical translation as targeted drug carriers for cancer chemotherapy.
{"title":"Potential applications of Folate-conjugated Chitosan Nanoparticles for Targeted delivery of Anticancer drugs","authors":"Prakash Nathaniel Kumar Sarella, Pavan Kumar Thammana","doi":"10.52711/0975-4377.2023.00045","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00045","url":null,"abstract":"Folate-conjugated chitosan nanoparticles represent a promising nanoplatform for targeted delivery of anticancer drugs. The nanoparticle carrier can protect the therapeutic agents from degradation and offer the ability to target cancer cells overexpressing folate receptors. This review summarizes recent research progress in synthesizing folate-conjugated chitosan nanoparticles as well as evaluating their potential as targeted drug delivery systems. The chemical conjugation of folic acid to chitosan is first discussed followed by an overview of different techniques for preparation of stable folate-conjugated chitosan nanoparticles less than 200 nm in size. Recent studies loading various anticancer drugs into these nanoparticles and investigating their in vitro cytotoxicity against multiple cancer cell lines are then summarized. The results indicate that folate-conjugated nanoparticles exhibit higher cytotoxicity and targeting efficiency compared to non-conjugated nanoparticles due to receptor-mediated endocytosis. Lastly, future challenges and opportunities are outlined including in vivo investigations to determine the effectiveness, toxicity, and pharmacokinetics of folate-conjugated chitosan nanoparticle systems as well as their potential clinical translation as targeted drug carriers for cancer chemotherapy.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"182 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139282260","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}
Pub Date : 2023-11-09DOI: 10.52711/0975-4377.2023.00043
A. Mursyid, R. Waris, Wahida W. Ilham, Asni Amin
The anti-inflammatory activity of Indian strawberry leaves is 0.31 percent DAI. For the treatment of inflammation, gel formulations are selected as effective penetration agents. The purpose of this work was to manufacture and test a pharmaceutically stable gel formulation of ethanol extract of Indian strawberry (Duchesnea indica (Jacks.) Focke] leaf with anti-inflammatory properties. This experimental study approach involved developing four formulas: F1 with 3% NaCMC, F2 with 4% NaCMC, F3 with 8% HPMC, and F4 with 9% HPMC. Then, the next test was evaluate the physical stability of the formulation using the following test parameters: organoleptic, pH, homogeneity, spreadability, and viscosity at 5°C and 35°C. The organoleptic test revealed that there was no difference between the four formulae in the color, odor, and consistency series. Each of the pH formulae that passed the pH test were suitable for topical application to the skin. For the homogeneity test all formulas are homogeneous. The best dispersion for the dispersion test was found in formulas 2, 3, and 4. Based on the rheogram, F1, F2, F3, and F4 had pseudoplastic flow characteristics. According to the results of the research conducted, the ethanol extract of Indian strawberry leaves can be formed into gel formulations based on HPMC and NaCMC. The gel formulation formula for ethanol extract of Indian strawberry leaves is pharmaceutically stable.
{"title":"Formulation of Gel Preparations of Ethanol Extract of Indian Strawberry (Duchesnea indica (Jacks.) Focke.)","authors":"A. Mursyid, R. Waris, Wahida W. Ilham, Asni Amin","doi":"10.52711/0975-4377.2023.00043","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00043","url":null,"abstract":"The anti-inflammatory activity of Indian strawberry leaves is 0.31 percent DAI. For the treatment of inflammation, gel formulations are selected as effective penetration agents. The purpose of this work was to manufacture and test a pharmaceutically stable gel formulation of ethanol extract of Indian strawberry (Duchesnea indica (Jacks.) Focke] leaf with anti-inflammatory properties. This experimental study approach involved developing four formulas: F1 with 3% NaCMC, F2 with 4% NaCMC, F3 with 8% HPMC, and F4 with 9% HPMC. Then, the next test was evaluate the physical stability of the formulation using the following test parameters: organoleptic, pH, homogeneity, spreadability, and viscosity at 5°C and 35°C. The organoleptic test revealed that there was no difference between the four formulae in the color, odor, and consistency series. Each of the pH formulae that passed the pH test were suitable for topical application to the skin. For the homogeneity test all formulas are homogeneous. The best dispersion for the dispersion test was found in formulas 2, 3, and 4. Based on the rheogram, F1, F2, F3, and F4 had pseudoplastic flow characteristics. According to the results of the research conducted, the ethanol extract of Indian strawberry leaves can be formed into gel formulations based on HPMC and NaCMC. The gel formulation formula for ethanol extract of Indian strawberry leaves is pharmaceutically stable.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139282170","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}
Pub Date : 2023-11-09DOI: 10.52711/0975-4377.2023.00037
Rohit S. Bhamare, Rajendra K. Surawase, Jayshree S. Bhadane
In the existing study focused on the solubility enhancement of lansoprazole by using solid dispersion technique. Lansoprazole is proton pump inhibitor (PPI). Lansoprazole is used for the treatment of gastric ulcer. Lansoprazole is the Class II Drug of Biopharmaceutical Classification system. By using novel solid dispersion methods to enhance the oral solubility of poor water-soluble drug. Lansoprazole has the low solubility and high permeability. Hence to enhance the solubility of lansoprazole we prepared the Lansoprazole solid dispersion (SD) with PVP K30, Poly Ethylene Glycol 6000 (PEG 6000) and Poloxamer 407. Lansoprazoledissolving tablet were formulated using various superdisintegrants like Crospovidone and Sodium Starch Glycolate by Direct compression. The prepared the tablet is evaluated at various parameters like weight variation, hardness, friability, disintegration time, drug content uniformity and In-vitro dissolution. The In-vitro Drug release study of solid dispersions SD6 show the high drug release around 98.93%. Overall, in the all formulations F12 which contains 6%, 3.75% and 10% of Crospovidone, SSG and MCC release the 98.93% drug is the best formulation.
{"title":"Solubility Enhancement of Lansoprazole by using Solid Dispersion Technique","authors":"Rohit S. Bhamare, Rajendra K. Surawase, Jayshree S. Bhadane","doi":"10.52711/0975-4377.2023.00037","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00037","url":null,"abstract":"In the existing study focused on the solubility enhancement of lansoprazole by using solid dispersion technique. Lansoprazole is proton pump inhibitor (PPI). Lansoprazole is used for the treatment of gastric ulcer. Lansoprazole is the Class II Drug of Biopharmaceutical Classification system. By using novel solid dispersion methods to enhance the oral solubility of poor water-soluble drug. Lansoprazole has the low solubility and high permeability. Hence to enhance the solubility of lansoprazole we prepared the Lansoprazole solid dispersion (SD) with PVP K30, Poly Ethylene Glycol 6000 (PEG 6000) and Poloxamer 407. Lansoprazoledissolving tablet were formulated using various superdisintegrants like Crospovidone and Sodium Starch Glycolate by Direct compression. The prepared the tablet is evaluated at various parameters like weight variation, hardness, friability, disintegration time, drug content uniformity and In-vitro dissolution. The In-vitro Drug release study of solid dispersions SD6 show the high drug release around 98.93%. Overall, in the all formulations F12 which contains 6%, 3.75% and 10% of Crospovidone, SSG and MCC release the 98.93% drug is the best formulation.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"62 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139282207","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}
An innovative method to increase the solubility of water insoluble drug by using Nanocrystallization. Various factor like solubility, dissolution drug release, temperature, ph, have its effect on these process. Solubility is the ability of a substance, the solute, to form a solution with another substance, the solvent. Solutes are classified as highly soluble, sparingly soluble, or insoluble based on the concentration. Dissolution is ability of molecule to get break down in it. There are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, and flow through cell, paddle over disc, rotating cylinder, and reciprocating disc. Drug release is when drug solutes migrate from the initial position in the polymeric system to the polymer's outer surface and then to the release medium. It is directly related to the drug stability. There are many mechanisms by which the drug release can be controlled in a system: dissolution, diffusion, osmosis, partitioning, swelling, erosion, and targeting. Drug Stabilizers are compounds, usually polysaccharides, which are added to products to provide and preserve structure, stability, and viscosity. Broadly there are 3 methods for the nanocrystallizationi.e. Bottom up technique, Top down technique and combination technique.
{"title":"Nanocrystallization - A Tool for Enhancement of Solubility and Dissolution Rate for Water Insoluble Drugs","authors":"Rajashri Shinde, Dhanshri Dhanbhar, Nikita Narad, Shivani Khandagale","doi":"10.52711/0975-4377.2023.00048","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00048","url":null,"abstract":"An innovative method to increase the solubility of water insoluble drug by using Nanocrystallization. Various factor like solubility, dissolution drug release, temperature, ph, have its effect on these process. Solubility is the ability of a substance, the solute, to form a solution with another substance, the solvent. Solutes are classified as highly soluble, sparingly soluble, or insoluble based on the concentration. Dissolution is ability of molecule to get break down in it. There are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, and flow through cell, paddle over disc, rotating cylinder, and reciprocating disc. Drug release is when drug solutes migrate from the initial position in the polymeric system to the polymer's outer surface and then to the release medium. It is directly related to the drug stability. There are many mechanisms by which the drug release can be controlled in a system: dissolution, diffusion, osmosis, partitioning, swelling, erosion, and targeting. Drug Stabilizers are compounds, usually polysaccharides, which are added to products to provide and preserve structure, stability, and viscosity. Broadly there are 3 methods for the nanocrystallizationi.e. Bottom up technique, Top down technique and combination technique.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139282145","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}
Pub Date : 2023-11-09DOI: 10.52711/0975-4377.2023.00038
Jaydeep S Chauhan, Jigar Vyas, U.M. Upadhyay
Introduction: The two key challenges for formulation scientists in developing therapeutic delivery are the dissolution and solubility of a low aqueous-soluble drug. Many powerful drug molecules do not have therapeutic effects owing to solubility concerns, yet they can be dangerous when administered in large dosages. Solid dispersion technology is a good method for increasing solubility and dissolution, along with bioavailability. Material and Methods: solid dispersion of rosuvastatin was developed using casein, infant formula, and poly-ethylene glycol 6000 by conventional fusion method and characterized for several characterization parameters. Conclusion: Solid dispersion of rosuvastatin was efficiently developed. The dissolution of rosuvastatin solid dispersion was discovered to be noticeably increased as compared to rosuvastatin API, according to the current investigation, SD of rosuvastatin was a superior alternative for increasing the dissolution of weakly soluble therapeutic agent.
{"title":"Enhancement of water solubility of Poorly Water-soluble drug using milk protein as carrier","authors":"Jaydeep S Chauhan, Jigar Vyas, U.M. Upadhyay","doi":"10.52711/0975-4377.2023.00038","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00038","url":null,"abstract":"Introduction: The two key challenges for formulation scientists in developing therapeutic delivery are the dissolution and solubility of a low aqueous-soluble drug. Many powerful drug molecules do not have therapeutic effects owing to solubility concerns, yet they can be dangerous when administered in large dosages. Solid dispersion technology is a good method for increasing solubility and dissolution, along with bioavailability. Material and Methods: solid dispersion of rosuvastatin was developed using casein, infant formula, and poly-ethylene glycol 6000 by conventional fusion method and characterized for several characterization parameters. Conclusion: Solid dispersion of rosuvastatin was efficiently developed. The dissolution of rosuvastatin solid dispersion was discovered to be noticeably increased as compared to rosuvastatin API, according to the current investigation, SD of rosuvastatin was a superior alternative for increasing the dissolution of weakly soluble therapeutic agent.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"80 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139282380","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}
Pub Date : 2023-11-09DOI: 10.52711/0975-4377.2023.00036
Joe Chou, Roger Lai, Jason Chou, Shelly Fu, Li Chuan Chung
In the generic drug formulation development, pilot bioequivalence (BE) study with a small group of subjects is the current practice for oral formulation prediction. However, due to the difficulty in differentiating the variation between subject and drug formulation with the current BE practice，a new instrument called PAMPA Dissolution is proposed to eliminate the subjects variation and to enhance the correlation between in vitro to in vivo absorption in BE study. PAMPA Dissolution simultaneously measures drug dissolution (Cb) and permeation (Pe), following the validated oral drug absorption equation F (drug absorbed) = Cb*Pe*Area. The use of biorelevant media further allows this device to mimic in vivo conditions closely. Formulations of 60 mg etoricoxib tablets were studied to verify system reproducibility and BE prediction to demonstrate the potential of PAMPA Dissolution in generic drug development. The BE predictions between generic and brand etoricoxib tablets (test/reference) from this system produced a Cmax value of 99.0% and AUC value of 99.1%, indicating that PAMPA Dissolution predictions conform with bioequivalence results. Other oral formulations of valsartan/hydrochlorothiazide, ezetimibe, telmisartan, and amlodipine were also tested for their permeation (Pe) by PAMPA Dissolution. Results of drug permeation compared to the literature values indicates that the PAMPA Dissolution is reliable and precise in formulation development.
{"title":"Improve Bioequivalence predictions with PAMPA Dissolution using Etoricoxib and five other Drug Formulations","authors":"Joe Chou, Roger Lai, Jason Chou, Shelly Fu, Li Chuan Chung","doi":"10.52711/0975-4377.2023.00036","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00036","url":null,"abstract":"In the generic drug formulation development, pilot bioequivalence (BE) study with a small group of subjects is the current practice for oral formulation prediction. However, due to the difficulty in differentiating the variation between subject and drug formulation with the current BE practice，a new instrument called PAMPA Dissolution is proposed to eliminate the subjects variation and to enhance the correlation between in vitro to in vivo absorption in BE study. PAMPA Dissolution simultaneously measures drug dissolution (Cb) and permeation (Pe), following the validated oral drug absorption equation F (drug absorbed) = Cb*Pe*Area. The use of biorelevant media further allows this device to mimic in vivo conditions closely. Formulations of 60 mg etoricoxib tablets were studied to verify system reproducibility and BE prediction to demonstrate the potential of PAMPA Dissolution in generic drug development. The BE predictions between generic and brand etoricoxib tablets (test/reference) from this system produced a Cmax value of 99.0% and AUC value of 99.1%, indicating that PAMPA Dissolution predictions conform with bioequivalence results. Other oral formulations of valsartan/hydrochlorothiazide, ezetimibe, telmisartan, and amlodipine were also tested for their permeation (Pe) by PAMPA Dissolution. Results of drug permeation compared to the literature values indicates that the PAMPA Dissolution is reliable and precise in formulation development.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"68 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139281877","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}
Pub Date : 2023-11-09DOI: 10.52711/0975-4377.2023.00042
Pushkar S. Chavan, Avish D. Maru, Majid S. Khan
Mouth dissolving films (MDFs) of captopril were developed using natural polymers, including pectin, sodium alginate, and guar gum, in combination with the plasticizer polyethylene glycol 400 (PEG 400) and other ingredients like saliva stimulating agent, sweetener and super disintegrator etc. A total of nine formulations were prepared using different concentrations of the polymers by the solvent casting method. The objective of the study was to evaluate the suitability of these polymers and the effect of polymer concentration on the performance of the MDFs. The MDFs were evaluated based on various parameters, including folding endurance, dissolution, and disintegration studies. Among the different formulations, batch F4, which contained 50% (w/w) pectin as the polymer and 17% (w/w) PEG 400 as the plasticizer, exhibited satisfactory results. The folding endurance test indicated that batch F4 had good flexibility and strength, suggesting that it could withstand repeated folding without breaking or cracking. The in vitro dissolution study revealed that the MDFs of batch F4 exhibited rapid and complete drug release in 6 min, indicating their potential for enhanced drug delivery. The disintegration study further confirmed that the MDFs disintegrated within a short time, ensuring rapid disintegration and dissolution of the drug in the oral cavity.
{"title":"Formulation and Evaluation of Mouth Dissolving Films of Captopril by using Natural Polymers.","authors":"Pushkar S. Chavan, Avish D. Maru, Majid S. Khan","doi":"10.52711/0975-4377.2023.00042","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00042","url":null,"abstract":"Mouth dissolving films (MDFs) of captopril were developed using natural polymers, including pectin, sodium alginate, and guar gum, in combination with the plasticizer polyethylene glycol 400 (PEG 400) and other ingredients like saliva stimulating agent, sweetener and super disintegrator etc. A total of nine formulations were prepared using different concentrations of the polymers by the solvent casting method. The objective of the study was to evaluate the suitability of these polymers and the effect of polymer concentration on the performance of the MDFs. The MDFs were evaluated based on various parameters, including folding endurance, dissolution, and disintegration studies. Among the different formulations, batch F4, which contained 50% (w/w) pectin as the polymer and 17% (w/w) PEG 400 as the plasticizer, exhibited satisfactory results. The folding endurance test indicated that batch F4 had good flexibility and strength, suggesting that it could withstand repeated folding without breaking or cracking. The in vitro dissolution study revealed that the MDFs of batch F4 exhibited rapid and complete drug release in 6 min, indicating their potential for enhanced drug delivery. The disintegration study further confirmed that the MDFs disintegrated within a short time, ensuring rapid disintegration and dissolution of the drug in the oral cavity.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"63 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139282315","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}
Dissolution (in vitro release) testing has been the subject of intense scientific and regulatory interest over the past several decades. As an analytical methodology, in vitro dissolution testing measures drug release into the dissolution media. The U. S. Food and Drug Administration (USFDA) Dissolution Database was reviewed and screened regarding the type of dosage forms, apparatus type, agitation speed, media volume, and recommended time points for the dissolution profile. The dissolution method requires special laboratory equipment, following a well-defined protocol. Basic information is available in the United States Pharmacopeia general chapters<711> Dissolution, <724> Drug Release, and <1092> The Dissolution Procedure – Development and Validation and these chapters were used as a starting point for this revision. The article describes current regulatory expectations for establishing a suitable dissolution method for implementing quality control tools, a way to maintain lot quality and consistency between development batches and post-approval commercial batches. Dissolution methods draw offers some advantages as a possible surrogate for extensive clinical studies in certain cases required after scale-up and post-approval changes in the product's life cycle and serves as an essential tool for establishing waivers for filing of lower strengths of the drug product. The step-by-step dissolution method development plan as per current regulatory perspectives and the factors to be considered are explained with examples. Scientist requires detailed insights on the selection of media and volumes, physicochemical properties of active substance, sink condition, type of enzymes, selection of apparatus, deaeration, sinkers, agitation speed, and time point’s measures. The advanced dissolution method is evaluated against its discriminatory power by intentionally varying formulation and process variables
{"title":"A Review on Dissolution Method Development for Drug Products: Current Regulations and Prospects","authors":"Prashant Gupta, Dipti H. Patel, Nilesh Dhameliya, Pratik Modh, Vishvesh Joshi","doi":"10.52711/0975-4377.2023.00047","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00047","url":null,"abstract":"Dissolution (in vitro release) testing has been the subject of intense scientific and regulatory interest over the past several decades. As an analytical methodology, in vitro dissolution testing measures drug release into the dissolution media. The U. S. Food and Drug Administration (USFDA) Dissolution Database was reviewed and screened regarding the type of dosage forms, apparatus type, agitation speed, media volume, and recommended time points for the dissolution profile. The dissolution method requires special laboratory equipment, following a well-defined protocol. Basic information is available in the United States Pharmacopeia general chapters<711> Dissolution, <724> Drug Release, and <1092> The Dissolution Procedure – Development and Validation and these chapters were used as a starting point for this revision. The article describes current regulatory expectations for establishing a suitable dissolution method for implementing quality control tools, a way to maintain lot quality and consistency between development batches and post-approval commercial batches. Dissolution methods draw offers some advantages as a possible surrogate for extensive clinical studies in certain cases required after scale-up and post-approval changes in the product's life cycle and serves as an essential tool for establishing waivers for filing of lower strengths of the drug product. The step-by-step dissolution method development plan as per current regulatory perspectives and the factors to be considered are explained with examples. Scientist requires detailed insights on the selection of media and volumes, physicochemical properties of active substance, sink condition, type of enzymes, selection of apparatus, deaeration, sinkers, agitation speed, and time point’s measures. The advanced dissolution method is evaluated against its discriminatory power by intentionally varying formulation and process variables","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"188 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139281656","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}
Pub Date : 2023-11-09DOI: 10.52711/0975-4377.2023.00039
Sandesh Y. Pawar, Rajendra K. Surawase
The aim of this study was to develop antihypertensive matrix tablets with sustained release of valsartan, an angiotensin type II receptor antagonist, using hydroxypropyl methylcellulose and combination of ethyl cellulose material as matrix in different proportions by wet granulation. The granules are evaluated by tapped density, bulk density, angle of repose and compressibility index. The tablets are tested for friability, hardness, weight variation and in vitro release. The granules showed good flow properties and compressibility properties and all tablet formulations showed pharmaceutical properties. The result of dissolution study indicate that the formulation prepared by combination of high grade HPMC K100M and ethyl cellulose showed maximum drug release for 12hrs and high drug release around 98.56% i.e., Formulation F8 is the best formulation.
{"title":"Formulation and Evaluation of Sustained Release Matrix Tablet of Valsartan","authors":"Sandesh Y. Pawar, Rajendra K. Surawase","doi":"10.52711/0975-4377.2023.00039","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00039","url":null,"abstract":"The aim of this study was to develop antihypertensive matrix tablets with sustained release of valsartan, an angiotensin type II receptor antagonist, using hydroxypropyl methylcellulose and combination of ethyl cellulose material as matrix in different proportions by wet granulation. The granules are evaluated by tapped density, bulk density, angle of repose and compressibility index. The tablets are tested for friability, hardness, weight variation and in vitro release. The granules showed good flow properties and compressibility properties and all tablet formulations showed pharmaceutical properties. The result of dissolution study indicate that the formulation prepared by combination of high grade HPMC K100M and ethyl cellulose showed maximum drug release for 12hrs and high drug release around 98.56% i.e., Formulation F8 is the best formulation.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139282142","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}
Pub Date : 2023-11-09DOI: 10.52711/0975-4377.2023.00041
Jaydeep Singh Chauhan, Jigar Vyas
The primary goal of treating burns that are deep and widespread and where the dermis layer has been damaged. And the natural ability of spontaneous re-epithelialization has been severely compromised or eliminated, is wound closure. Burn victims experience mental suffering because of the scarring that arises from their functional and cosmetic damage. Iodine's primary purpose in wound treatment is as an antibacterial agent. For many decades, povidone iodine has been used and studied in wound healing. Copper oxide- based wound dressings accelerate wound healing through angiogenesis, regeneration, and antibacterial qualities. With its powerful antibacterial capabilities, copper is a vital mineral that is important for many physiological and metabolic processes, including angiogenesis, skin production, expression, and stability of extracellular skin proteins. These two characteristics work together to make copper a desirable mineral for enhancing skin wellbeing. As a result, when copper oxide is added to standard items, the result is an improved product. Several compositions for Gel made of poloxamer (p188) and poloxamer(p407). Poloxamer Gels (TPGEL) are excellent thermosensitive polymers for topical application because they exist as low-viscosity liquids at ambient temperature but as Gels at body temperature.
{"title":"Development of Thermoreversible In-situ gel containing copper ions to cure moderate skin burns","authors":"Jaydeep Singh Chauhan, Jigar Vyas","doi":"10.52711/0975-4377.2023.00041","DOIUrl":"https://doi.org/10.52711/0975-4377.2023.00041","url":null,"abstract":"The primary goal of treating burns that are deep and widespread and where the dermis layer has been damaged. And the natural ability of spontaneous re-epithelialization has been severely compromised or eliminated, is wound closure. Burn victims experience mental suffering because of the scarring that arises from their functional and cosmetic damage. Iodine's primary purpose in wound treatment is as an antibacterial agent. For many decades, povidone iodine has been used and studied in wound healing. Copper oxide- based wound dressings accelerate wound healing through angiogenesis, regeneration, and antibacterial qualities. With its powerful antibacterial capabilities, copper is a vital mineral that is important for many physiological and metabolic processes, including angiogenesis, skin production, expression, and stability of extracellular skin proteins. These two characteristics work together to make copper a desirable mineral for enhancing skin wellbeing. As a result, when copper oxide is added to standard items, the result is an improved product. Several compositions for Gel made of poloxamer (p188) and poloxamer(p407). Poloxamer Gels (TPGEL) are excellent thermosensitive polymers for topical application because they exist as low-viscosity liquids at ambient temperature but as Gels at body temperature.","PeriodicalId":20963,"journal":{"name":"Research Journal of Pharmaceutical Dosage Forms and Technology","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139281663","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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