Research Journal of Pharmaceutical, Biological and Chemical Sciences
Design and Development of Immediate and Sustained Release Tablets of Vildagliptin.
Combined drug therapy (CDT) is favoring for most of the treatment and the goal of the therapy is to decrease or reduce dose dependent adverse drug reactions and side effects. The present work an attempt to design bilayer tablets of Atorvastatin immediate release and Aspirin Pulsatile release for the treatment of cardiovascular diseases. Four formulations were prepared for immediate release layer of atorvastatin using different concentrations of Microcrystalline cellulose and Talc by direct compression method. For aspirin pulsatile release layer, the four formulations of core tablets were prepared using Microcrystalline cellulose, Talc. The different concentrations of Cross carmellose sodium and Sodium starch glycolate were selected as superdisintegrants in F1, F2 and F3, F4 formulations. Then the core tablets were coated with Eudragit S 100 as enteric polymer. Physico chemical parameters of bilayer tablets were performed and it has shown a good drug release profile. The work reveals that F3 formulation was the best formulation and they are the good candidate for lowering the risk of heart attack. Pattern like one layer of the formulation as immediate release to reduce the cholesterol level and the second layer to deliver the drug at right time and in right amount, to reduce the risk of heart attack. However stability studies and further clinical trials are needed to improve the tablet formulation by quality wise as well as efficacy wise.
ABSTRACT
Hyperglycemia is the technical term for high blood glucose (sugar). It
happens when the body has too little or not enough insulin or when the
body can‘t use insulin properly. The main objective of the present
research work was to develop a bilayer tablet of immediate release
Pioglitazone and controlled release Metformin Hydrochloride, which is
used as an Anti-hyperglycemic agent. Metformin Hydrochloride has
biological half-life nearly about 6 hours, so, an attempt was made in
the direction of preparation and optimization of a combination of
sustained release and immediate release in a single tablet. In controlled
release layer natural gums like xanthum gum, gum trgacanth and guar
gum were used as retarding materials and in immediate release laye
croscarmellose sodium was used as a superdisintegrent to give the faster release of
pioglitazone. The tablets were prepared by wet granulation method and by direct
compression. Granules were evaluated for precompression parameters and the tablets were
evaluated for post compression parameters.
Key Words: Bilayer tablets, Metformin Hydrochloride, pioglitazone, xanthum gum, guar
gum, gum tragacanth and crosscarmellose sodium.
Combined drug therapy (CDT) is favoring for most of the treatment and the goal of the therapy is to decrease or reduce dose dependent adverse drug reactions and side effects. The present work an attempt to design bilayer tablets of Atorvastatin immediate release and Aspirin Pulsatile release for the treatment of cardiovascular diseases. Four formulations were prepared for immediate release layer of atorvastatin using different concentrations of Microcrystalline cellulose and Talc by direct compression method. For aspirin pulsatile release layer, the four formulations of core tablets were prepared using Microcrystalline cellulose, Talc. The different concentrations of Cross carmellose sodium and Sodium starch glycolate were selected as superdisintegrants in F1, F2 and F3, F4 formulations. Then the core tablets were coated with Eudragit S 100 as enteric polymer. Physico chemical parameters of bilayer tablets were performed and it has shown a good drug release profile. The work reveals that F3 formulation was the best formulation and they are the good candidate for lowering the risk of heart attack. Pattern like one layer of the formulation as immediate release to reduce the cholesterol level and the second layer to deliver the drug at right time and in right amount, to reduce the risk of heart attack. However stability studies and further clinical trials are needed to improve the tablet formulation by quality wise as well as efficacy wise.
ABSTRACT
Hyperglycemia is the technical term for high blood glucose (sugar). It
happens when the body has too little or not enough insulin or when the
body can‘t use insulin properly. The main objective of the present
research work was to develop a bilayer tablet of immediate release
Pioglitazone and controlled release Metformin Hydrochloride, which is
used as an Anti-hyperglycemic agent. Metformin Hydrochloride has
biological half-life nearly about 6 hours, so, an attempt was made in
the direction of preparation and optimization of a combination of
sustained release and immediate release in a single tablet. In controlled
release layer natural gums like xanthum gum, gum trgacanth and guar
gum were used as retarding materials and in immediate release laye
croscarmellose sodium was used as a superdisintegrent to give the faster release of
pioglitazone. The tablets were prepared by wet granulation method and by direct
compression. Granules were evaluated for precompression parameters and the tablets were
evaluated for post compression parameters.
Key Words: Bilayer tablets, Metformin Hydrochloride, pioglitazone, xanthum gum, guar
gum, gum tragacanth and crosscarmellose sodium.
Effect of hydrophilic polymers on solubility of some antihypertentives drugs ...SriramNagarajan19
The main aim of the present study is to carried out to enhance solubility of Felodipine. Felodipine.was selected as model drug and different carriers like Vitamin-E, Polyethylene Glycol 8000, Polyvinyl pyrrolidone K-30 were used in drug to carrier ratio 1:1, 1:2, 1:4 by weight respectively. Solid dispersions were prepared by physical mixing method and solvent evaporation method. Solid dispersions were evaluated by drug content, in-vitro release, FT-IR, DSC and XRD. The obtained data of solid dispersion prepared by solvent evaporation method were compared with physical mixing method. The result showed decrease in melting point change from crystalline to amorphous form and improved dissolution rate as compared to physical mixing as well as pure Felodipine. The finding of present study proposes that solid dispersion approach is beneficial in enhancing solubility of drug and bioavailability as well.
Development and Evaluation of Enteric Coated Herbal Drug Delivery System for ...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Development and evaluation of a novel twice daily cup core metformin hydrochl...SriramNagarajan19
The study was undertaken with an aim to formulate develop and evaluation of a novel twice daily core cup of Metformin hydrochloride(Antidiabetic drug) tablets using different grades and weight of HPMC polymers as release retarding agent. Granules were evaluated for tests Bulk density, tapped density, Hausner ratio before being punched as tablets. Tablets were tested for weight variation, thickness, hardness and friability as per official procedure. F-2 was found to be 73.90. From the above results and discussion it is concluded that formulation of Cup core tablet of containing Metformin hydrochloride HPMC K 4M & 215: 230 (in mg) can be taken as an ideal or optimized formulation of sustained release tablets for 12hour release as it fulfills all the requirements for sustained release tablet and our study encourages for the further clinical trials on this formulation. The core in cup tablets of Metformin hydrochloride were prepared by wet granulation method, they were evaluated for weight variation, friability, hardness, and thickness for all batches (F1 – F9). No significant difference was observed in the weight of individual tablets from the average weight. The weight variation tests were performed according to the procedure given in the pharmacopoeia. In a weight variation test, pharmacopoeial limit of tablet for percentage deviation is 5%. The average percentage deviation of all tablet formulation was found to be within the pharmacopoeial limit and hence all formulation passed the test for uniformity of weight.
Piroxicam Nanostructured Lipid Carrier Drug Delivery SystemYogeshIJTSRD
Objective Nanostructured lipid carrier NLC based topical gel of Piroxicam PXM was formulated with the aim of controlled release action and to reduce systemic side effect for the treatment of an arthritic condition. Methods NLCs developed using high pressure homogenization method and optimized using a 32 factorial design with response surface methodology using design expert software. NLCs were characterized for particle size, zeta potential analysis, drug entrapment efficiency, and in vitro drug release studies to select the optimized formulation. The NLCs were suitably gelled and evaluated with respect to homogeneity, pH, viscosity, gel strength, spread ability, rheological characteristics, drug content, in vitro diffusion, and stability study. Safety of the NLC based gel was assessed using primary skin irritation studies, and efficacy was confirmed using carrageen an induced rat paw edema model. Results NLCs formulation comprising 2 of lipid 60 40 and surfactant 1.50 was confirmed as an optimized batch having a particle size 138.2±3.60 nm with polydispersibility index value 0.344±0.034. The zeta potential value indicates good physical stability. Based on the results from the in vitro release study it was shown that the formed gels had the ability to extend release of PXM for 24 h and showing percentage drug release of 90.92 ±1.96 at the end of 24 h. Skin irritation studies revealed that the optimized gel formulation shows no erythema, edema, or ulceration. Conclusion The overall results of the present study clearly indicated promising potentials of NLC based gel for delivering PXM topically over the conventional gel. Dr. G. Jagadish | Dr. Rita Mourya | Dr. Amith Nayak "Piroxicam Nanostructured Lipid Carrier Drug Delivery System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3 , April 2021, URL: https://www.ijtsrd.com/papers/ijtsrd39912.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/39912/piroxicam-nanostructured-lipid-carrier-drug-delivery-system/dr-g-jagadish
Formulation and Evaluation of Nimodipine Tablet by Liquisolid Techniqueijtsrd
Liquisolid technique is novel concept of the drug delivery via the oral route. This technique is applied to poorly water soluble , water insoluble or lipophilic drugs. According to the new formulation method of liquisolid compact, liquid medication such as solution or suspensions of water insoluble drug in suitable non volatile solvent can be converted into acceptably flowing and compressible powders by blending with selected powder excipients. The present work endeavour is directed towards the development of liquisolid compact for production of immediate release tablet of water insoluble Nimodipine. Liquisolid compacts were prepared by using polyethylene glycol 300 as the liquid vehicle or non volatile solvent. Crospovidone was used as a superdisintegrating agent and PVP K30 as a binder. Microcrystalline cellulose was used as a absorbing carrier and silicone dioxide as adsorbing coating material. The prepared liquisolid system were evaluated for their micromeretic properties and possible drug excipients interaction . The FTIR spectra study ruled out any interaction between the drug and excipients in preparation of Nimodipine liquisolid compact. The in vitro dissolution study confirmed enhance drug release from liquisolid compacts by using USP type I basket in 0.5 SLS in water. The selected optimal formula released 93.86 of its content in 30 min which is showing immediate release. The results showed that use of superdisintegrants had remarkable impact on the release rate of Nimodipine from Liquisolid compact, enhancing the release rate of the drug from liquisolid compact. Neha Durge | Kirti Parida ""Formulation and Evaluation of Nimodipine Tablet by Liquisolid Technique"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-4 , June 2019, URL: https://www.ijtsrd.com/papers/ijtsrd23863.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/23863/formulation-and-evaluation-of-nimodipine-tablet-by-liquisolid-technique/neha-durge
Bilayer tablet is suitable for sequential release of two drugs in combination and also for controlled release tablet in which one layer is for immediate release as initial dose and the second layer is for controlled release or maintenance dose. Bilayer tablet is an improved beneficial technology to overcome the shortcoming of the monolayer tablet. This technology avoids frequent administration of dosage form. Now a days such technology is used for co-administration of two drugs like anti-diabetic, anti-hypertensive, anti-inflammatory to the patients. Conventional solid oral dosage forms are a traditional approach, but bilayer tablet is a novel approach that requires new machinery for manufacturing. The technique is cost effective, safe and reproducible.
Formulation development and invitro evaluation of lamotrigine fast dissolving...SriramNagarajan19
The present study was to formulate and evaluate oral fast dissolving Oral tablet containing Lamotrigine. Present study reveals that all the nine formulated tablet showed satisfactory tablet parameters. It can be concluded that, Oral fast dissolving tablet -containing Lamotrigine can be prepared by direct compression method. 10% CCS (FV) tablet exhibited required disintegration time and dissolution time. The drug release was about 98.7 % in 15min. The accelerated stability studies of the optimized F5 formulation indicates that the formulated oral fast dissolving tablet were unaffected after 3 months storage under accelerated conditions as there were no signs of visually distinguishable changes in appearance, disintegration time and cumulative percentage of drug release. From the present investigation it can be concluded that oral fast dissolving tablet formulation can be a potential novel drug dosage form for pediatric, geriatric and also for general population.
Preparation and evaluation of kollidon sr matrix tablets of tinidazole for co...IJSIT Editor
Amoebiasis is an infection of the large intestine caused by Entamoeba histolytica, and it is mainly
present in the intra-intestinal lumen. The efficient treatment of amoebiasis and other colonic infections could
be achieved by targeting the drug to the colon. Tinidazole is the drug of choice for intestinal amoebiasis and
other colonic infections and the best approach for this drug is to target the drug to the colon which would
make the drug effective with low dose and prevent the potential hazards observed in conventional dose.
Moreover, addition of suitable polymers in the formulation could enhance the drug solubility. The aim of the
present investigation was to formulate matrix formulations using different concentrations of Kollidon SR and
PVP K-30, Eudragit S100 to prevent the premature drug release in the GI tract, the matrix formulations
further taken for compression to test the suitability for targeted drug delivery to the colon. The release
kinetics of the formulations was calculated. All the Matrix, compression coated formulations showed the
desired physicochemical properties as per the official limits. Based on the drug release study in pH 1.2 (0.1N
HCl), Phosphate buffer pH 6.8 and the results showed that among the 9 formulations FE2 and FL3 showed
good dissolution profile to control the drug release respectively.
Formulation and Drug Release of Isoxsuprine HCL Enteric Coated TabletsINFOGAIN PUBLICATION
The aim of the study is to formulate and evaluate enteric coated tablets using Isoxsuprine Hydrochloride as a model drug. Different core tablets and enteric coated tablets were prepared and drug release was studied. Isoxsuprine Hydrochloride core tablets were prepared by wet granulation method, using polymers, by changing drug ratios. The granules are evaluated for physical properties and the in-vitro drug release studies. Enteric coating was carried out using different sub coating materials. Enteric coating was performed in a mini coating pan at 107 rpm using low-pressure air atomized liquid spray technique. By changing the coating material, were done single coated, Double coated tablets are evaluated for uniformity hardness, friability, invitro disintegration and dissolution studies. The in-vitro drug release data was fitted into various kinetic models. All the formulations showed the values within the prescribed limit. It was observed that the higher rate and drug release was observed for the double coated tablets, this is because second layer having high viscosity.
Zoloft is an anti-depressant medication, used for treating major depression, panic disorder, anxiety disorders and more. GDD, put an Zoloft Generic on sale at low price. Buy Zoloft Generic and treat your depression at minimal health cost.
Crown Medical Research and Pharmaceutical Sciences College of Canada offers opportunities to expand your experience beyond the classroom and support them with guidance on career opportunities.
Our professors, consultants, and course developers are recognized leaders in professional development and training in the field of pharmaceutical, natural health products, quality assurance and quality control, regulatory affairs and submissions, pharmacovigilance and drug safety reporting, clinical research, cosmetics, food sciences, biopharmaceutical, and health care policy and services management.
We strive to continuously evolve and expand our programs in an attempt to respond effectively to changing technologies and workforce demands in the industry. It is with this strategy that our programs will prepare our learners for their future.
When attending our college, you will be exposed to highly qualified professionals and professors as well as students with diverse backgrounds and proven professional abilities seeking to improve their skill set and employment outlook.
We are located at Richmond Hill, in the Greater Toronto Area, that is one of the 3 biggest financial and social center in North America. This gives learners access to the head quarters of many industries and to be exposed to personal, and professional growth opportunities.
Our college offers academic counseling program through one-on-one meetings with professors and collaborators and we offer faculty-mentoring program to assist students in improving their learning and working strategies for reaching faster their career goals.
When you are considering to enroll in a certificate course offered by our college, please explore the program information on the website and contact us for a one-on-one mentoring meeting, to visit the campus, and to get a career consultation at any time. Our intensive courses start every month and our learners can start their program with us at any time during the year.
Achieve your career goals in a short period of time with a very competitive education and get Canadian experience with the highest quality of supervised training.
Effect of hydrophilic polymers on solubility of some antihypertentives drugs ...SriramNagarajan19
The main aim of the present study is to carried out to enhance solubility of Felodipine. Felodipine.was selected as model drug and different carriers like Vitamin-E, Polyethylene Glycol 8000, Polyvinyl pyrrolidone K-30 were used in drug to carrier ratio 1:1, 1:2, 1:4 by weight respectively. Solid dispersions were prepared by physical mixing method and solvent evaporation method. Solid dispersions were evaluated by drug content, in-vitro release, FT-IR, DSC and XRD. The obtained data of solid dispersion prepared by solvent evaporation method were compared with physical mixing method. The result showed decrease in melting point change from crystalline to amorphous form and improved dissolution rate as compared to physical mixing as well as pure Felodipine. The finding of present study proposes that solid dispersion approach is beneficial in enhancing solubility of drug and bioavailability as well.
Development and Evaluation of Enteric Coated Herbal Drug Delivery System for ...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Development and evaluation of a novel twice daily cup core metformin hydrochl...SriramNagarajan19
The study was undertaken with an aim to formulate develop and evaluation of a novel twice daily core cup of Metformin hydrochloride(Antidiabetic drug) tablets using different grades and weight of HPMC polymers as release retarding agent. Granules were evaluated for tests Bulk density, tapped density, Hausner ratio before being punched as tablets. Tablets were tested for weight variation, thickness, hardness and friability as per official procedure. F-2 was found to be 73.90. From the above results and discussion it is concluded that formulation of Cup core tablet of containing Metformin hydrochloride HPMC K 4M & 215: 230 (in mg) can be taken as an ideal or optimized formulation of sustained release tablets for 12hour release as it fulfills all the requirements for sustained release tablet and our study encourages for the further clinical trials on this formulation. The core in cup tablets of Metformin hydrochloride were prepared by wet granulation method, they were evaluated for weight variation, friability, hardness, and thickness for all batches (F1 – F9). No significant difference was observed in the weight of individual tablets from the average weight. The weight variation tests were performed according to the procedure given in the pharmacopoeia. In a weight variation test, pharmacopoeial limit of tablet for percentage deviation is 5%. The average percentage deviation of all tablet formulation was found to be within the pharmacopoeial limit and hence all formulation passed the test for uniformity of weight.
Piroxicam Nanostructured Lipid Carrier Drug Delivery SystemYogeshIJTSRD
Objective Nanostructured lipid carrier NLC based topical gel of Piroxicam PXM was formulated with the aim of controlled release action and to reduce systemic side effect for the treatment of an arthritic condition. Methods NLCs developed using high pressure homogenization method and optimized using a 32 factorial design with response surface methodology using design expert software. NLCs were characterized for particle size, zeta potential analysis, drug entrapment efficiency, and in vitro drug release studies to select the optimized formulation. The NLCs were suitably gelled and evaluated with respect to homogeneity, pH, viscosity, gel strength, spread ability, rheological characteristics, drug content, in vitro diffusion, and stability study. Safety of the NLC based gel was assessed using primary skin irritation studies, and efficacy was confirmed using carrageen an induced rat paw edema model. Results NLCs formulation comprising 2 of lipid 60 40 and surfactant 1.50 was confirmed as an optimized batch having a particle size 138.2±3.60 nm with polydispersibility index value 0.344±0.034. The zeta potential value indicates good physical stability. Based on the results from the in vitro release study it was shown that the formed gels had the ability to extend release of PXM for 24 h and showing percentage drug release of 90.92 ±1.96 at the end of 24 h. Skin irritation studies revealed that the optimized gel formulation shows no erythema, edema, or ulceration. Conclusion The overall results of the present study clearly indicated promising potentials of NLC based gel for delivering PXM topically over the conventional gel. Dr. G. Jagadish | Dr. Rita Mourya | Dr. Amith Nayak "Piroxicam Nanostructured Lipid Carrier Drug Delivery System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3 , April 2021, URL: https://www.ijtsrd.com/papers/ijtsrd39912.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/39912/piroxicam-nanostructured-lipid-carrier-drug-delivery-system/dr-g-jagadish
Formulation and Evaluation of Nimodipine Tablet by Liquisolid Techniqueijtsrd
Liquisolid technique is novel concept of the drug delivery via the oral route. This technique is applied to poorly water soluble , water insoluble or lipophilic drugs. According to the new formulation method of liquisolid compact, liquid medication such as solution or suspensions of water insoluble drug in suitable non volatile solvent can be converted into acceptably flowing and compressible powders by blending with selected powder excipients. The present work endeavour is directed towards the development of liquisolid compact for production of immediate release tablet of water insoluble Nimodipine. Liquisolid compacts were prepared by using polyethylene glycol 300 as the liquid vehicle or non volatile solvent. Crospovidone was used as a superdisintegrating agent and PVP K30 as a binder. Microcrystalline cellulose was used as a absorbing carrier and silicone dioxide as adsorbing coating material. The prepared liquisolid system were evaluated for their micromeretic properties and possible drug excipients interaction . The FTIR spectra study ruled out any interaction between the drug and excipients in preparation of Nimodipine liquisolid compact. The in vitro dissolution study confirmed enhance drug release from liquisolid compacts by using USP type I basket in 0.5 SLS in water. The selected optimal formula released 93.86 of its content in 30 min which is showing immediate release. The results showed that use of superdisintegrants had remarkable impact on the release rate of Nimodipine from Liquisolid compact, enhancing the release rate of the drug from liquisolid compact. Neha Durge | Kirti Parida ""Formulation and Evaluation of Nimodipine Tablet by Liquisolid Technique"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-4 , June 2019, URL: https://www.ijtsrd.com/papers/ijtsrd23863.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/23863/formulation-and-evaluation-of-nimodipine-tablet-by-liquisolid-technique/neha-durge
Bilayer tablet is suitable for sequential release of two drugs in combination and also for controlled release tablet in which one layer is for immediate release as initial dose and the second layer is for controlled release or maintenance dose. Bilayer tablet is an improved beneficial technology to overcome the shortcoming of the monolayer tablet. This technology avoids frequent administration of dosage form. Now a days such technology is used for co-administration of two drugs like anti-diabetic, anti-hypertensive, anti-inflammatory to the patients. Conventional solid oral dosage forms are a traditional approach, but bilayer tablet is a novel approach that requires new machinery for manufacturing. The technique is cost effective, safe and reproducible.
Formulation development and invitro evaluation of lamotrigine fast dissolving...SriramNagarajan19
The present study was to formulate and evaluate oral fast dissolving Oral tablet containing Lamotrigine. Present study reveals that all the nine formulated tablet showed satisfactory tablet parameters. It can be concluded that, Oral fast dissolving tablet -containing Lamotrigine can be prepared by direct compression method. 10% CCS (FV) tablet exhibited required disintegration time and dissolution time. The drug release was about 98.7 % in 15min. The accelerated stability studies of the optimized F5 formulation indicates that the formulated oral fast dissolving tablet were unaffected after 3 months storage under accelerated conditions as there were no signs of visually distinguishable changes in appearance, disintegration time and cumulative percentage of drug release. From the present investigation it can be concluded that oral fast dissolving tablet formulation can be a potential novel drug dosage form for pediatric, geriatric and also for general population.
Preparation and evaluation of kollidon sr matrix tablets of tinidazole for co...IJSIT Editor
Amoebiasis is an infection of the large intestine caused by Entamoeba histolytica, and it is mainly
present in the intra-intestinal lumen. The efficient treatment of amoebiasis and other colonic infections could
be achieved by targeting the drug to the colon. Tinidazole is the drug of choice for intestinal amoebiasis and
other colonic infections and the best approach for this drug is to target the drug to the colon which would
make the drug effective with low dose and prevent the potential hazards observed in conventional dose.
Moreover, addition of suitable polymers in the formulation could enhance the drug solubility. The aim of the
present investigation was to formulate matrix formulations using different concentrations of Kollidon SR and
PVP K-30, Eudragit S100 to prevent the premature drug release in the GI tract, the matrix formulations
further taken for compression to test the suitability for targeted drug delivery to the colon. The release
kinetics of the formulations was calculated. All the Matrix, compression coated formulations showed the
desired physicochemical properties as per the official limits. Based on the drug release study in pH 1.2 (0.1N
HCl), Phosphate buffer pH 6.8 and the results showed that among the 9 formulations FE2 and FL3 showed
good dissolution profile to control the drug release respectively.
Formulation and Drug Release of Isoxsuprine HCL Enteric Coated TabletsINFOGAIN PUBLICATION
The aim of the study is to formulate and evaluate enteric coated tablets using Isoxsuprine Hydrochloride as a model drug. Different core tablets and enteric coated tablets were prepared and drug release was studied. Isoxsuprine Hydrochloride core tablets were prepared by wet granulation method, using polymers, by changing drug ratios. The granules are evaluated for physical properties and the in-vitro drug release studies. Enteric coating was carried out using different sub coating materials. Enteric coating was performed in a mini coating pan at 107 rpm using low-pressure air atomized liquid spray technique. By changing the coating material, were done single coated, Double coated tablets are evaluated for uniformity hardness, friability, invitro disintegration and dissolution studies. The in-vitro drug release data was fitted into various kinetic models. All the formulations showed the values within the prescribed limit. It was observed that the higher rate and drug release was observed for the double coated tablets, this is because second layer having high viscosity.
Zoloft is an anti-depressant medication, used for treating major depression, panic disorder, anxiety disorders and more. GDD, put an Zoloft Generic on sale at low price. Buy Zoloft Generic and treat your depression at minimal health cost.
Crown Medical Research and Pharmaceutical Sciences College of Canada offers opportunities to expand your experience beyond the classroom and support them with guidance on career opportunities.
Our professors, consultants, and course developers are recognized leaders in professional development and training in the field of pharmaceutical, natural health products, quality assurance and quality control, regulatory affairs and submissions, pharmacovigilance and drug safety reporting, clinical research, cosmetics, food sciences, biopharmaceutical, and health care policy and services management.
We strive to continuously evolve and expand our programs in an attempt to respond effectively to changing technologies and workforce demands in the industry. It is with this strategy that our programs will prepare our learners for their future.
When attending our college, you will be exposed to highly qualified professionals and professors as well as students with diverse backgrounds and proven professional abilities seeking to improve their skill set and employment outlook.
We are located at Richmond Hill, in the Greater Toronto Area, that is one of the 3 biggest financial and social center in North America. This gives learners access to the head quarters of many industries and to be exposed to personal, and professional growth opportunities.
Our college offers academic counseling program through one-on-one meetings with professors and collaborators and we offer faculty-mentoring program to assist students in improving their learning and working strategies for reaching faster their career goals.
When you are considering to enroll in a certificate course offered by our college, please explore the program information on the website and contact us for a one-on-one mentoring meeting, to visit the campus, and to get a career consultation at any time. Our intensive courses start every month and our learners can start their program with us at any time during the year.
Achieve your career goals in a short period of time with a very competitive education and get Canadian experience with the highest quality of supervised training.
Formulation and Evaluation of Gliclazide Immediate Release and Metformin Sust...ijtsrd
The aim of the present work is to formulate and evaluate a bilayer tablet BT of Metformin HCl as Sustained release and Gliclazide as Immediate release IR . The polymer used in sustained release is HMPC K100M and the super disintegrant used in immediate release in proportion of Gum Karaya and Croscarmellose sodium by Direct compression method. The Preformulation studied, Bulk density, Tapped density, Housner’s ratio, Carr’s index, Angle of repose and UV of Metformin HCl and Gliclazide is performed. In this study, a bilayer tablet containing gliclazide in IRL and metformin in SRL was made using the direct compression method, with the goal of making the formulations IRL as small as possible. Will release gliclazide as soon as possible to combat postprandial hyperglycaemic level, followed by steady state plasma glucose management by Metformin with a long term release. The hardness of the different formulations ranged from 7.5 8.5 kg cm. All the formulations exhibited less than 1 friability. The drug content analysis of Metformin and Gliclazide in all formulations was found within the I P limits ±5 which indicate that the drug was uniformly distributed in the tablets. The in vitro dissolution study was performed for layer I Metformin up to 12 hrs after every 1hour intervals and for layer II Gliclazide up to 40 min after every 5 min interval . The bilayer tablet contributing initial loading dose and dissolves rapidly, the remainder of the drug in the extended release was constant rate till the end of the dissolution process. The DSC and I.R spectra proved that there was no interaction between the polymer excipients and Metformin, Gliclazide. The stability study of Formulation F4 showed after three months that there was no degradation and the drug was stable under accelerated and real time stability conditions. Gajanan Ramasane | Sujit Kakade | Ashok Bhosale "Formulation and Evaluation of Gliclazide Immediate Release and Metformin Sustain Release Bilayer Tablet" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50372.pdf Paper URL: https://www.ijtsrd.com/humanities-and-the-arts/education/50372/formulation-and-evaluation-of-gliclazide-immediate-release-and-metformin-sustain-release-bilayer-tablet/gajanan-ramasane
Formulation and Evaluation of Sublingual Tablet of Enalapril Maleate By 32 Fu...PRASANTAKUMARMOHAPAT3
The aim of this work was to formulate and evaluate sublingual tablets of Enalapril maleate for
rapid management of Hypertension. In the present work, the metallic taste of Enalapril maleate
was masked by using Kyron T-114 in 1:2 ratio. The Drug-Resin Complex was formulated as
sublingual tablets using Cross Povidone (X1) and Avicel PH102 (X2) by direct compression
method. The sublingual tablets were evaluated such as thickness, hardness, % Friability, Wetting
time, disintegration time, Water absorption ratio and % CDR. In this study, the fast release of
tablets depends on the concentration of Cross Povidone (X1) and Avicel PH102 (X2). The
selected formulation showed the fastest release of the tablets in 45 s. Stability study was
performed by taking an optimized formulation and it was observed stable. The sublingual tablets
showed acceptable results in all studies. The results indicate that the formulation can be used for
rapid management of Hypertension. Also, Enalapril maleate’s bioavailability may be increased
by selecting sublingual route of administration.
ABSTRACT
Purpose: The main objective of present research investigation is to formulate the sustained release tablet of
Simvastatin using 32
factorial design. Simvastatin, an antihyperlipidemic agent, belongs BCS class-II agent.
Methods: The SR tablets of Simvastatin were prepared employing different concentrations of HPMCK4M and
SCMC in different combinations by wet granulation technique using 32
factorial design. The concentration of
Polymers , HPMCK4M and SCMC required to achieve the desired drug release was selected as independent
variables, X1
and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%)
and 90% (t90%) were selected as dependent variables. Results and Discussion: Totally nine formulations were
designed and are evaluated for hardness, friability, thickness, % drug content, In-vitro drug release. From the
Results it was concluded that all the formulation were found to be with in the Pharmacopoeial limits and the Invitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters
like intercept, slope & regression coefficient were calculated. Polynomial equations were developed for t10%,
t
50%, t75%, t90%. Validity of developed polynomial equations were verifiedby designing 2 check point formulations
(C1
, C2
). According to SUPAC guidelines the formulation (F4
) containing combination of 17.5% HPMCK4M and
30% SCMC, is the most similar formulation (similarity factor f2
= 89.652, dissimilarity factor f1
= 1.6424 & No
significant difference, t= 0.00558) to marketed product (ZOCOR). Conclusion: The selected formulation (F4
)
follows Zero order, Higuchi’s kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion
(n= 0.963).
Keywords: Simvastatin, 32 Factorial Design, Sustained Release Tablet, HPMCK4M ,SCMC, SUPAC, Non-Fickian
Diffusion Mechanism, Zero order kinetics
Objective: The purpose of present research work is to develop the sustained release formulation for Telmisartan using 32 factorial design. Telmisartan an Antihypertensive agent, nonpeptide angiotensin-II receptor (type AT1) antagonist and BCS class-II agent. Methods: Sustained Release tablet formulations of Telmisartan were prepared using different quantities of HPMCK100M and Xanthan Gum in combinations by direct compression technique. The concentration of Polymers, HPMCK100M and Xanthan gum required to achieve the drug release was selected as independent variables, X1 and X2 respectively whereas, time required for 10% of drug release (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables. Nine formulations were prepared and are evaluated for various pharmacopoeial tests. Results: The results reveals that all formulations were found to be with in the pharmacopoeial limits and In vitro drug release profiles of all formulations were fitted in to various Kinetic models. The statistical parameters like intercept, slope & correlation coefficient were calculated. Polynomial equations were developed for dependent variables. Validity of developed polynomial equations were checked by designing 2 check point formulations (C1, C2). Conclusion: According to SUPAC guidelines formulation (F5) containing combination of 15% HPMCK100M and 15% Xanthan gum, is the most identical formulation (similarity factor f2= 90.863, dissimilarity factor f1= 1.665 & No significant difference, t= 0.03379) to marketed product (TELVAS). Best Formulation F5 follows First order, Higuchi’s kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion Anomalous Transport. (n= 0.828).
Objective: The purpose of the present research investigation was to formulate sustained release (SR) formulations for
losartan potassium using 32
factorial designs. Methods: Losartan potassium is an antihypertensive agent, non-peptide
angiotensin-II receptor (type AT1) blocker, and BCS class-III agent. SR tablet formulations of losartan potassium were
formulated using variable quantities of hydroxymethyl propyl cellulose (HPMC) K100M and xanthan gum in combinations
by direct compression technique. The amount of polymers, HPMC K100M, and xanthan gum required to achieve the drug
release was selected as independent variables, X1
and X2
, respectively, whereas time required to release 10% (t10%), 50%
(t50%), 75% (t75%), and 90% (t90%) of drug from formulation was selected as dependent variables. Nine formulations were
prepared and evaluated for various pharmacopoeial tests. Results: The results reveal that all formulations were found to be
with in the pharmacopoeial limits and in vitro drug release profiles of all formulations were subjected to kinetic modeling.
The statistical parameters such as intercept, slope, and correlation coefficient were determined. Polynomial equations were
developed for dependent variables. Validity of developed polynomial equations was checked by designing two checkpoint
formulations (C1
and C2
). According to SUPAC guidelines, formulation (F4
) containing mixture of 15% HPMC K100M
and 20% xanthan gum is the most identical formulation (similarity factor f2 = 86.747, dissimilarity factor f1 = 1.760, and no
significant difference, t = 0.0477) to marketed product (LOSACAR). Conclusion: Best Formulation F4 follows the first-order,
Higuchi kinetics, and the mechanism of drug release was found to be non-Fickian diffusion anomalous transport (n = 0.825).
KEY WORDS: 32 factorial design, First-order kinetics, Hydroxymethyl propyl cellulose K100M, Losartan potassium,
Non-fickian diffusion mechanism, Sustained release tablet, Xanthan gum
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Best Ayurvedic medicine for Gas and IndigestionSwastikAyurveda
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
E2 design and development of immediate and sustained release tablets of vildagliptin
1. ISSN: 0975-8585
July - August 2014 RJPBCS 5(4) Page No. 811
Research Journal of Pharmaceutical, Biological and Chemical Sciences
Design and Development of Immediate and Sustained Release Tablets of Vildagliptin.
Priyanka Shrestha1*, Shiva Kumar Bhandari1, SM Ashraful Islam1, Md Selim Reza2,
and Santosh Adhikari3.
1Department of Pharmacy, University of Asia Pacific, Dhanmondi, Dhaka-1209, Bangladesh
2Department of Pharmaceutical Technology, University of Dhaka, Dhaka-1000, Bangladesh
3Department of Pharmacy, Rajiv Gandhi University of Health Sciences, Banglore-560 041, Karnataka, India.
ABSTRACT
In this study immediate release and sustained release tablets of Vildagliptin was developed. Pharmabrust was used as super disintegrating agent in increasing order in immediate release formulations and methocel k4M CR as rate retarding polymer in sustained release formulations. Tablets were formulated by direct compression method. The in-vitro release profile were determined using USP I apparatus. The release profile of immediate release tablet of all the formulations was 95-100% within 45 minutes. The release profile of sustained release FS-1, FS-2, FS-3, FS-4, FS-5, FS-6 and FS-7 was 94%, 99%, 72%, 76%, 65% and 74% within 8 hours. Formulated tablets were evaluated for physical parameters such as average weight, thickness, disintegration time, potency, LBD, TBD, compressibility Index and angle of repose. All the physical properties of prepared tablets were within limit. Zero order, First order, Higuchi and Korsmeyer et al. models were used to estimate the kinetics of drug release. It was found that the release followed First order release kinetics, as the correlation coefficient R2 value was higher for first order i.e. 0.995. Formulation 6 of immediate release tablet (FI-6) seems to be best similar to the innovator brand for higher f2 i.e. 51.6 and lower f1 value i.e. 3. Formulations were characterized by Fourier transform infrared (FTIR). No any chemical interaction was observed between excipients and drug from IR spectrum.
Keywords: Vildagliptin, immediate release, sustained release, pharmabrust, methocel k4M CR, in-vitro study.
*Corresponding author
2. ISSN: 0975-8585
July - August 2014 RJPBCS 5(4) Page No. 812
INTRODUCTION
Type 2 diabetes mellitus is a growing problem in most parts of the world. There is now good evidence that controlling hyperglycaemia can help prevent many of the serious complications associated with the disease [1]. Current drugs used for managing TYPE II Diabetes and its precursor syndromes, such as insulin resistance, fall into different classes of compound such as the biguanides, thiazolidinediones, the sulfonylureas peptide analogus, dipeptidyl Peptidase-IV inhibitors and alpha glucosidase inhibitors [2]. Among the most promising new classes of drugs for type 2 diabetes are those that leverage the incretin hormone glucagon-like peptide-1 (GLP-1) [1]. Vildagliptin is an oral anti diabetic drug from the peptide analogues (DPP- 4 inhibitor class).Vildagliptin can be given in monotherapy as well as in combination with other antidiabetic drugs. It rapidly and completely inhibits the activity of DPP- 4 enzymes this results in increase of the two incretin hormones available in our body, they are glucose-like peptide- 1(GLP-1) and glucose dependent insulinotropic peptide (GIP). The activation of these two hormones results in decrease of the blood glucose level by decreasing the glucagon secretion and increase of insulin sensitivity. GLP-1 activation enhances the β-cell sensitivity and reduces the α-cell sensitivity which results in increase in amount of insulin and decreases the amount of glucagon and reduces the glucose level in blood [6].
Sustained-release oral delivery systems are designed to achieve therapeutically effective concentrations of drug in the systemic circulation over an extended period of time, thus achieving better patient compliance and allowing a reduction of both the total dose of drug administered and the incidence of adverse side effects [3]. In long-term therapy, for the treatment of chronic disease conditions, conventional formulations are required to be administered in multiple doses and therefore have several disadvantages [4]. Matrix devices, due to their chemical inertness, drug embedding ability and drug release character, have gained steady popularity for sustaining the release of a drug [5].
The literature survey shows that there is no any published paper on discriminating dissolution study of Vildagliptin tablets and there is no any information about dissolution medium and λmax value of Vildagliptin in BP and USP for in-vitro. So we conducted the discriminating dissolution study for the selection of appropriate dissolution medium and suitable λmax. The purpose of this work is to design the immediate and sustained release tablets of Vildagliptin. To formulate immediate release tablets polymer pharmabrust was used in increasing amount from FI-1 to FI-7 formulations and polymer methocel k4M CR at increasing order were used to formulate sustained release tablets FS-1 to Fs-7 formulations. Pharmabrust is a co-processed excipient system with specific excipients, which allows rapid disintegration and low adhesion to punches. Pharmabrust is smooth and creamy and helps to mask taste and grittiness of the actives. Main advantages Pharmabrust is highly compatible, rapid disintegration and cost effective [7]. Methocel K4M premium are semi synthetic derivative of cellulose. They are swellable and hydrophilic polymer. They are suitable to use as a retardant material in SR matrix tablets, as they are non toxic and easy to handle [8]. Matrix tablets prepared using Methocel polymer on contact with aqueous fluids gets hydrated to form a
3. ISSN: 0975-8585
July - August 2014 RJPBCS 5(4) Page No. 813
viscous gel layer through which drug will be released by diffusion and/or by erosion of the matrix [9].
MATERIALS AND METHODS
Materials
The Vildagliptin were provided by Popular Pharmaceutical Ltd., Dhaka, Bangladesh. Acetonitrile of HPLC grade was purchased from E. Merck, Darmstadt, Germany. Anhydrous Potassium Dihydrogen Phosphate, Potassium Hydroxide, Phosphoric acid and other reagents were of analytical-reagent grade and purchased from E. Merck, Darmstadt, Germany. Water was deionised and double distilled. Six commercial brands of tablets containing 50 mg Vildagliptin were purchased from local drug shops in Dhaka city after checking their manufacturing license numbers, batch numbers, production and expiry dates.
Preparation of immediate release (IR) sustained release (SR) tablets of Vildagliptin
Immediate release (IR) tablet of Vildagliptin were formulated using superdisintegrating polymer i.e. pharmabrust in increasing amount 10, 20, 30, 40, 60, 70 and 80 mg. In the same way, sustained release (SR) tablet of Vildagliptin were formulated using methocel K4M CR polymer in increasing amount in the same range respectively. The compositions of immediate release tablet FI and sustained release tablet FS are summarized in Table 1 and Table 2.
Table 1: Immediate release formulation of Vildagliptin
Ingredients for Immediate Formulations
FI-1
FI-2
FI-3
FI-4
FI-5
FI-6
FI-7
Vildagliptin
50
50
50
50
50
50
50
Pharmabrust
10
20
30
40
60
70
80
Mannitol
60
60
60
60
60
60
60
Microcrystalline Cellulose (Avicel PH 101)
150
150
150
150
150
150
150
Mg-Stearate
1
1
1
1
1
1
1
Table 2: Sustained release formulation of Vildagliptin
Ingredients for Sustained Formulations
FS-1
FS-2
FS-3
FS-4
FS-5
FS-6
FS-7
Vildagliptin
50
50
50
50
50
50
50
Methocel K4M CR
10
20
30
40
60
70
80
Mannitol
60
60
60
60
60
60
60
Microcrystalline Cellulose (Avicel PH 101)
150
150
150
150
150
150
150
Mg-Stearate
1
1
1
1
1
1
1
4. ISSN: 0975-8585
July - August 2014 RJPBCS 5(4) Page No. 814
Evaluation of granules
Granules from all the formulation were evaluated for bulk density, compressibily index, angle of Repose.
LBD (Loose Bulk Density) and TBD (Tabbed Bulk Density) were determined by Tab density tester. Initial volume and tapped volume of 2 gm of granules were observed and LBD, TBD, compressibility index and hausner ratio was calculated from the following equations:
LBD = Weight of the powder / volume of the packing.
TBD = Weight of the powder / Tapping volume of the packing.
Carr’s index (%) = {(TBD – LBD) X 100}/TBD
Hausner ratio= Tabbed density/ Bulk density
The angle of repose of granules was determined by following granules through the funnel freely to surface. The radius ® and height (h) of the powder cone was measured and angle of repose was calculated using the following equation:
Angle of Repose θ = tan-1 h/r
Where, h = Height of the powder cone.
r = Radius of the powder cone
Evaluation of Tablets
All the prepared tablets were evaluated for its uniformity of weight, hardness, friability and thickness according to official methods. The average weights and percentage deviation were calculated by weighing 20 tablets from each brand by an analytical weighing balance. The crushing strength was determined with an Automatic Tablet Hardness Tester (8M, Dr Schleuniger, Switzerland).
HPLC Analysis of Vildagliptin
The HPLC method has been developed by using a mixture of acetonitrile and buffer (30:70 v/v) as a mobile phase which was pumped at a flow rate of 0.5 ml/min through the column (C18; 5μ, 4.6 X 150 mm, Waters, USA) at ambient temperature. The injection volume was 10 μl. The objective is to develop and validate a rapid, selective and sensitive HPLC method for determination of Vildagliptin from its pharmaceutical dosage form that have short and simple extraction procedures, consume small amount of solvent for extraction in a short turnaround time. The method is developed using the protocols set out in the International Conference on Harmonization (ICH) guidelines [10].
20 tablets were accurately weighed and the average weight was calculated. Then one tablet weight 50 mg was taken into 50 ml amber volumetric flask and 3 ml of water is added in it to disperse the tablet, then 30 ml of diluting solution was added and the solution was shake
5. ISSN: 0975-8585
July - August 2014 RJPBCS 5(4) Page No. 815
thoroughly at 250 rpm for 10 minutes by using vortex mixer. Then the volume was adjusted up to the mark with diluting solution. The prepared solution was sonicated for 10 minutes then cooled to room temperature and filtered through whatman filter paper. 1 ml of this solution was taken in 25 ml amber volumetric flask and diluted with diluting solution and volume adjusted up to the mark. Then the resultant solution was filtered through 0.45 μ- disc filter.
Potency determination of Vildagliptin tablets
20 mg equivalent Vildagliptin was taken from each immediate release and sustained release formulation and dissolved in 100 ml water and sonicated. Then again 10 ml was taken from there and volume was adjusted upto100ml. From that solution absorbance was measured. Then the concentarion mcg/ml was calculated. Then the potency was calculated from the obtained result.
Dissolution method development for Vildagliptin tablet
Selection of suitable rpm
The dissolution study of Brand A of Vildagliptin was carried on different paddle rpm (75 and 50) for the selection of suitable rpm.
Selection of dissolution medium
The dissolution study of marketed product of Vildagliptin was carried in different media (Buffer pH 1.2, pH 4.5, pH 6.8, pH 7.8 and water) to select the suitable media for the dissolution study.
In- vitro Release Studies of prepared tablets of Vildagliptin
The in-vitro dissolution tests were performed by using the selected rpm, wavelength and dissolution medium. In-vitro dissolution study was performed in 900 ml distilled water. The temperature of the medium was maintained at 37oC ± 0.5oC throughout the experiment. The USP dissolution test apparatus type II (Paddle type) was used and the rpm (rotation per minute) was set to 75. At 5, 15, 30, 45 and 60 minutes for immediate release formulations and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours for sustained release formulations (10ml) of aliquots were collected for analysis which was then replaced with equal volume of fresh dissolution medium. From the samples collected, absorbance was measured at both λmax values 210 and 212nm using Shimadzu UV – 1700 UV/Visible Double Beam Spectrophotometer (Shimadzu, Japan). Percentage of the drug release was calculated.
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RESULTS AND DISCUSSION
Formulation development of immediate release and sustained release tablets of Vildagliptin
The results of physical parameters (weight, hardness, thickness, LBD, TBD, angle of repose, Compressibility index and disintegration time) and potency of the prepared immediate release tablets are shown in Table 3, 4 and 5. The thickness of the tablets were found between 5.43 ± 0.05 mm to 6.67 ± 0.09 mm, hardness of the tablets ranged from 8.69 ± 0.52 kg/cm2 to 9.29 ± 0.14 kg/cm2. And of sustain release tablets are shown in Table 6, 7, 8. The thickness of the SR tablets was found between 4.36 ± 0.04 mm to 4.87 ± 0.12 mm. The weight variations of prepared IR and SR tablets complied with the pharmacopoeial specifications. The drug content of every formulation was found about to 100% of labeled content. So it can be said that physical properties and drug content of the compressed immediate release tablets were satisfactory.
Table 3: Physical properties of the prepared powder of different immediate formulations
Parameters
FI-1
FI-2
FI-3
FI-4
FI-5
FI-6
FI-7
LBD (g/cm3)
0.3
0.305
0.332
0.332
0.356
0.377
0.385
TBD (g/cm3)
0.469
0.48
0.498
0.521
0.516
0.58
0.565
Compressibility Index (%)
36.03
36.45
33.33
36.27
31.1
35
31.85
Angle of Repose
50
49
48
52
45
47
49
Table 4: Evaluation of physical properties of IR tablet formulation
Formulation
Average Weight (mg)
Thickness
(mm)
Hardness (N)
Disintegration Time (min)
FI-1
261.425
5.43 ± 0.05
8.90 ± 0.60
1.2
FI-2
271.725
5.55 ± 0.1
9.13 ± 0.37
1.3
FI-3
275.225
6.3 ± 0.14
8.82 ± 0.08
1.2
FI-4
278.25
6.48 ± 0.01
8.73 ± 0.24
1
FI-5
292.65
6.55 ± 0.05
9.29 ± 0.14
1.4
FI-6
301.5
6.1 ± 0.08
9.01 ± 0.33
1.2
FI-7
291.5
6.67 ± 0.09
8.69 ± 0.52
1.3
Table 5: Potency determination of immediate release tablet
Formulation Code
Potency %
FI-1
100.60 ± 0.19
FI-2
99.12 ± 0.37
FI-3
99.26 ± 0.42
FI-4
99.67 ± 0.71
FI-5
100.27 ± 0.36
FI-6
99.44 ± 0.21
FI-7
100 ± 0.62
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Table 6: Physical properties of the prepared powder of different sustained formulations
Parameters
FS-1
FS-2
FS-3
FS-4
FS-5
FS-6
FS-7
LBD (g/cm3)
0.313
0.324
0.353
0.375
0.392
0.412
0.416
TBD (g/cm3)
0.5
0.506
0.529
0.554
0.562
0.58
0.585
Compressibility Index (%)
37.4
35.96
33.27
32.31
30.24
28.96
28.88
Angle of Repose
48
46
43
42
40
40
38
Table 7: Evaluation of physical properties of SR tablet formulation
Formulation
Average Weight (mg)
Thickness
(mm)
Disintegration Time (min)
FS-1
221.65
4.36 ± 0.04
25
FS-2
204.65
4.33 ± 0.01
64
FS-3
238.35
4.39 ± 0.01
120
FS-4
316.85
4.72 ± 0.07
Not disintegrated till 120 min
FS-5
308.55
4.565 ± 0.04
Not disintegrated till 120 min
FI-6
313.75
4.685 ± 0.02
Not disintegrated till 120 min
FI-7
320.8
4.865 ± 0.12
Not disintegrated till 120 min
Table 8: Potency determination of sustained release tablet
Formulation Code
Potency %
FS-1
100.60 ± 0.56
FS-2
99.53 ± 0.37
FS-3
97.80 ± 0.42
FS-4
100.67 ± 0.71
FS-5
98.27 ± 0.47
FS-6
99.00 ±0.89
FS-7
99.39 ±0.19
Dissolution method development
Selection of suitable rpm
The dissolution study of Brand A of Vildagliptin was carried on different paddle rpm for the selection of suitable rpm. The result shows that the percent release of brand A Vildagliptin was greater in the case of 75 rpm as compared to the 50 rpm so we select the 75 rpm for further in vitro dissolution study.
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Figure 2: Percent release curve in 75 rpm and 50 rpm
Selection of suitable medium for dissolution study
At first Brand A market product of Vildagliptin was used for dissolution study. In the study different dissolution medium was used, the percent release data of brand A in different dissolution medium is shown in following Figure3 and 4. From the above result we can conclude that the percent release from Brand A product was best in water as a dissolution medium and wavelength at 212nm.
Figure 3: Percent release from Brand A Vildagliptin at 210 nm (left) and 212nm (right)
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HPLC
Figure 4: Chromatogram of Vildagliptin
Determination of potency of marketed product of immediate release Vildagliptin tablets by HPLC
The proposed method was used to determine the potency of commercially available tablets (Six brands) containing 50 mg of Vildagliptin. Three replicate determinations i.e. n=3 were carried out and the results are summarized in Figure 5.
Figure 5: Graph showing potency of marketed product of immediate release tablets of Vildagliptin by HPLC
In the above bar graph, we can see that the market product F has the maximum potency i.e.95.43%. The other products A, B, C, D, E have 92.11%, 93.83%, 94.77%, 91.98% and 90.05% respectively.
In- vitro Release Studies of prepared tablets of Vildagliptin
As from the above market product in vitro dissolution study we are able to select the water as a dissolution medium and value of λmax 212nm. So the in-vitro dissolution study of formulated tablet was carried on water medium. The percent release data of seven formulations of immediate release tablet (FI-1 to FI-7) are shown in the following figure 6.
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Figure 6: Percent release curve of IR tablets in water at different λmax values
The above result shows that the drug release profile from immediate release tablets was around 100% within an hour for all the formulation. The use of super disintegrating agent in formulation gives the faster release rate [11]. The percent release data of seven formulations of sustained release tablets (FS-1 to FS-7) are shown in the following figure 7. The drug release from the tablet was sustained for 8 hr. Drug release decreased with increase of polymer loading as methocelK4M CR polymers form viscous gelatinous layer (gel layer) upon exposure to aqueous medium by undergoing rapid hydration and chain relaxation and this gel layer acts as the barrier to release of drug and as a result drug release is prolonged.
Figure 7: Percent release from SR formulation at λmax 212nm
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Drug release kinetics of sustained release formulations
The correlation coefficients values of the trend lines of the graphs showed that all 7 formulations best fit in First order release pattern, as the highest correlation coefficient i.e. R2=0.995 was obtained from this drug release kinetics which shows that our sustained release formulations release pattern depends on the initial concentration of drug. As the amount of
drug decreases, the release rate gradually decreases.
Figure 9: First order release curve Figure 8: Zero order release curve
Figure 10: Higuchi curve Figure 11: Korsmeyer curve
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Table 10: Correlation coefficient (R²) values of different formulation in different plot
Zero order
1st order
Higuchi
Korsmeyer
R²
R²
R²
R²
FS-1
y = 9.504x + 27.66
y = -0.055x + 1.625
y = 31.56x + 8.879
y = 0.751x + 0.059
R² = 0.733
R² = 0.983
R² = 0.927
R² = 0.974
FS-2
y = 8.941x + 31.68
y = -0.093x + 1.706
y = 30.70x + 12.07
y = 0.751x + 0.067
R² = 0.657
R² = 0.808
R² = 0.888
R² = 0.967
Fs-3
y = 8.719x + 25.95
y = -0.068x + 1.748
y = 29.20x + 8.241
y = 0.737x + 0.056
R² = 0.733
R² = 0.995
R² = 0.943
R² = 0.976
FS-4
y = 7.116x + 26.39
y = -0.03x + 1.681
y = 24.78x + 10.12
y = 0.718x + 0.062
R² = 0.639
R² = 0.973
R² = 0.888
R² = 0.970
Fs-5
y = 7.018x +33.57
y = -0.016x + 1.506
y = 25.74x + 15.04
y = 0.731x + 0.076
R² = 0.516
R² = 0.972
R² = 0.797
R² = 0.957
FS-6
y = 6.319x + 26.58
y = -0.017x + 1.664
y = 22.58x + 11.03
y = 0.728x + 0.153
R² = 0.579
R² = 0.880
R² = 0.848
R² = 0.667
FS-7
y = 8.018x + 21.83
y = -0.046x + 1.759
y = 26.72x + 5.803
y = 0.721x + 0.043
R² = 0.736
R² = 0.805
R² = 0.937
R² = 0.983
Table 11: Comparison of dissolution (f1 and f2) data with innovator brand
Immediate release formulations (IR)
f2
f1
FI-1
50.89
14
FI-2
50.98
10
FI-3
50.98
10
FI-4
51.02
13
FI-5
51.38
5
FI-6
51.6
3
FI-7
50.98
13
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Table 11 shows the f1 and f2 values of different brands in respect of innovator brand. Similarity factor f2 has been adopted by FDA (1997) and the European Agency for the Evaluation of Medicinal Products by the Committee for Proprietary Medicinal Products (CPMP) to compare dissolution profile. Two dissolution profiles are considered similar and bioequivalent, if f1 is between 0 and 15 and f2 is between 50 and 100. F-6 seems to be best similar to the innovator brand for higher f2 (51.6) and lower f1 value (3).
Drug-Excipients compatibility studies
Physical compatibility studies were assured by FT-IR studies. The IR spectrums of the mixed powders were taken by preparing potassium bromide pellets under dry condition by using pellet press. Spectra are superimposed. The transmission minima (absorption maxima) in the spectra obtained with the sample corresponded in position and relative size to those in the spectrum obtained with the working/reference standards. The polymer and the drug compatibility were evaluated by spectral as show in Figure 12, 13 and 14.
Figure 12: FT-IR Spectra of pure drug Vildagliptin
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Figure 13: FTIR Spectra of immediate release formulation of Vildagliptin
Figure 14: FTIR Spectra of sustained release formulation of Vildagliptin
CONCLUSION
The present work was to design the immediate and sustained release tablets of
Vildagliptin and their in-vitro study. The immediate release tablets were prepared by using
pharmabrust as superdisintegrating agent. The use of super disintegrating agent in formulation
gave the faster release rate. The sustained release tablets were prepared by using methocel
K4M CR as retardant polymer. Drug release decreased with increase of polymer loading as
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methocelK4M CR polymer form viscous gelatinous layer which acts as the barrier to release of drug and as a result drug release is prolonged.
ACKNOWLEDGEMENT
The authors are thankful to the management and lab technicians of University of Asia Pacific, Department of Pharmacy, Dhaka, Bangladesh for providing the necessary facilities to carry out this work.
REFERENCES
[1] Pratley RE, Afshin S, Glenn M. Br J Diabetes Vasc Dis 2006; 6:150-6.
[2] https://www.aace.com/files/dm-guidelines-ccp.pdf
[3] Vergnaud JM. Controlled drug release from oral dosage forms, Ellis Horwood Limited, London, 1993.
[4] Chien YW. Novel drug delivery systems; ed. by Chien Y W, Marcel Dekker, Inc; New York, 1992; 139-196.
[5] Basak SC, Kumar KS and Ramalingam M. Brazilian J Pharm Sci 2008;44(3):477-482.
[6] Amori RE, Lau J, Pittas AG. J American Med Assoc 2007; 298:194-206.
[7] Chaudhary SA, Chaudharya AB, Mehtab TA. Int J Res Pharm Sci 2010; 2: 103-107.
[8] Perez-Marcos B, Ford JL, Amstrong DJ, Elliott PNC, Rostron C and Hogan JW. Int J Pharm 1994; 111: 251-259.
[9] Wagner JG. J Pharm Sci 1969; 58: 1253-1257.
[10] EMEA. European Medicines Agency. Validation of Analytical Procedures: Text and Methodology. London: Canary Wharf; 1995:1-15.
[11] Velmurugan S, Vinushitha S. Int J Chem Pharm Sci 2010; 1(2).