Gastroretentive drug delivery is an approach to
prolong gastric residence time, thereby
targeting site-specific drug release in the upper
gastrointestinal tract (GIT) for local or
systemic effects. The various approaches are discussed with advantages like sustained drug delivery, increased bioavailability and site specific drug delivery.
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
The main objective of present investigation is to formulate the floating tablets of
Ranitidine.HCl using 32 factorial design. Ranitidine.HCl, H2-receptor antagonist belongs to
BCS Class-III. The Floating tablets of Ranitidine.HCl were prepared employing different
concentrations of HPMCK4M and Guar Gum in different combinations as a release rate
modifiers by Direct Compression technique using 32 factorial design. The concentration of
Polymers , HPMCK4M and Guar Gum required to achieve 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.
Totally nine formulations were designed and are evaluated for hardness, friability, thickness,
% drug content, Floating Lag time, In-vitro drug release. From the Results concluded that all
the formulation were found to be within the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the
statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated.
Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed
polynomial equations were verified by designing 2 check point formulations(C1, C2).
According to SUPAC guidelines the formulation (F5) containing combination of 22.5%
HPMCK4M and 22.5% Guar Gum, is the most similar formulation (similarity factor f2=85.01,
dissimilarity factor f1= 15.358 & No significant difference, t= 0.169) to marketed product
(ZANTAC). The selected formulation (F5) follows Higuchi’s kinetics, and the mechanism of
drug release was found to be Non-Fickian Diffusion (n= 0.922).
Application Of Polymer In Controlled Release FormulationAnindya Jana
Polymers are becoming increasingly important in the field of drug delivery. The pharmaceutical applications of polymers range from their use as binders in tablets to viscosity and flow controlling agents in liquids, suspensions and emulsions. Polymers can be used as film coatings to disguise the unpleasant taste of a drug, to enhance drug stability and to modify drug release characteristics.
As a consequence, increasing attention has been focused on methods of giving drugs continually for a prolonged time periods and in a controlled fashion.
This technology now spans many fields and includes pharmaceutical, food and agricultural applications, pesticides, cosmetics, and household products.
Gastroretentive drug delivery is an approach to
prolong gastric residence time, thereby
targeting site-specific drug release in the upper
gastrointestinal tract (GIT) for local or
systemic effects. The various approaches are discussed with advantages like sustained drug delivery, increased bioavailability and site specific drug delivery.
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
The main objective of present investigation is to formulate the floating tablets of
Ranitidine.HCl using 32 factorial design. Ranitidine.HCl, H2-receptor antagonist belongs to
BCS Class-III. The Floating tablets of Ranitidine.HCl were prepared employing different
concentrations of HPMCK4M and Guar Gum in different combinations as a release rate
modifiers by Direct Compression technique using 32 factorial design. The concentration of
Polymers , HPMCK4M and Guar Gum required to achieve 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.
Totally nine formulations were designed and are evaluated for hardness, friability, thickness,
% drug content, Floating Lag time, In-vitro drug release. From the Results concluded that all
the formulation were found to be within the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the
statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated.
Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed
polynomial equations were verified by designing 2 check point formulations(C1, C2).
According to SUPAC guidelines the formulation (F5) containing combination of 22.5%
HPMCK4M and 22.5% Guar Gum, is the most similar formulation (similarity factor f2=85.01,
dissimilarity factor f1= 15.358 & No significant difference, t= 0.169) to marketed product
(ZANTAC). The selected formulation (F5) follows Higuchi’s kinetics, and the mechanism of
drug release was found to be Non-Fickian Diffusion (n= 0.922).
Application Of Polymer In Controlled Release FormulationAnindya Jana
Polymers are becoming increasingly important in the field of drug delivery. The pharmaceutical applications of polymers range from their use as binders in tablets to viscosity and flow controlling agents in liquids, suspensions and emulsions. Polymers can be used as film coatings to disguise the unpleasant taste of a drug, to enhance drug stability and to modify drug release characteristics.
As a consequence, increasing attention has been focused on methods of giving drugs continually for a prolonged time periods and in a controlled fashion.
This technology now spans many fields and includes pharmaceutical, food and agricultural applications, pesticides, cosmetics, and household products.
ABSTRACT
The main objective of present investigation is to formulate the sustained release tablet of Metoprolol Succinate
using 32 factorial design. Metoprolol Succinate, is a selective β1blocker, to treat Hypertension & Heart Failure. The
SR tablets of Metoprolol Succinate were prepared employing different concentrations of HPMCK15M and
HPMCK100M in different combinations as a rate retardants by Direct Compression technique using 32 factorial
design. The quantity of rate retarders, HPMCK15M and HPMCK100M 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. 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 (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for t10%,
t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations(C1,
C2). According to SUPAC guidelines the formulation (F5) containing combination of 10% HPMCK15M and 10%
HPMCK100M, is the most similar formulation (f2=92.38 & No significant difference, t= 0.0216) to marketed
product (Metocard). The selected formulation (F5) follows Higuchi’s kinetics, the mechanism of drug release was
found to be Super case II transport (Non-Fickian, n= 0.981).
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
ABSTRACT
Objective: The main objective of present investigation is to formulate the controlled release tablet of Lamivudine using 3² factorial design. Lamivudine, a basic molecule and antiretroviral drug belongs to BCS Class III, having low permeability and high solubility. Methods: The controlled release tablets of lamivudine were prepared employing different concentrations of Carboplol974P and Xanthan gum in different combinations as a rate retarding agent by Direct Compression technique using 32 factorial design. The quantity/ concentration of rate retarders, Carboplol974P and Xanthan gum 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%, t50%, t75%,t90% were selected as dependent variables. Results: 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 in-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for t10%, t50%, t75%,t90%. Conclusions: According to SUPAC guidelines the formulation (F5) containing combination of 10% Carboplol974P and 10% Xanthan gum, is the most similar formulation (similarity factor f2=85.04 & No significant difference, t= 0.20046) to Innovator product (Lamivir). The selected formulation (F5) follows Higuchi’s kinetics, and the mechanism of drug release was found to be Case-II transport or typical Zero order release (Non-Fickian, n= 0.915).
ABSTRACT The purpose of this study was to prepare and evaluate immediate release itraconazole pellets and comprehensive studies of the same. The itraconazole pellets is prepared using fluid bed processer with different concentration of HPMC (Hydroxy Propyl Methyl Cellulose). The physicochemical compatibility of the drug and the excipient studied by differential scanning calorimetry. The prepared pellets were physically evaluated with size, shape, bulk density, tapped density, compressibility index, hausners ratio, angle of repose, sieve analysis, surface roughness, density, moisture content, assay and drug release etc. The in vitro drug release profile from pellets shows that all the formulation release more than 75% drug within 90min. Optimized formulations were found to have HPMC concentration 2-5% of total weight of pellets to maximize high-quality surface, desired release, and size distribution within the range. These results indicate that pellets containing 10 % HPMC of total weight of pellets give better quality of itraconazole pellets for immediate release. Key Words: Itraconazole, Hydroxyl propyl methyl cellulose and Immediate release.
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
ABSTRACT
The main objective of present research work is to formulate the of Domperidone Maleate floating tablets.
Domperidone Maleate, an antiemetic and a prokinetic agent belongs to BCS Class-II and Indicated for treatment of
upper gastrointestinal motility disorders by blocking the action of Dopamine. The Floating tablets of Domperidone
Maleate were prepared employing different concentrations of HPMCK4M and Guar Gum in different combinations
as a release rate modifiers by Direct Compression technique using 32 factorial design. The concentration of
HPMCK4M and Guar Gum was selected as independent variables, X1 and X2 respectively whereas, time required
for drug dissolution t10%, t50%,t75%,t90%were selected as dependent variables. Totally nine formulations were designed
and are evaluated for hardness, friability, thickness, Assay, Floating Lag time, In-vitro drug release. From the
Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like
intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for t10%,
t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations(C1,
C2). According to SUPAC guidelines the formulation (F5) containing combination of 18.75% HPMCK4M and
18.75% Guar Gum, is the most similar formulation (similarity factor f2=89.03, dissimilarity factor f1= 11.539& No
significant difference, t= 0.169) to marketed product (DOMSTAL OD). The selected formulation (F5) follows
Higuchi’s kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.925).
Keywords: Domperidone Maleate, 32Factorial Design, Gastro retentive Floating Tablet, HPMCK100M, Sodium
bicarbonate, Floating Lag Time, SUPAC, Non-Fickian Diffusion Mechanism.
Objective: The purpose of present research work is to develop the sustained release
formulation for Olmesartan medoxomil using 32
factorial design. Olmesartan an
Antihypertensive agent, angiotensin‒II receptor (type AT1) blocker and BCS class‒II
agent.
Methods: Sustained Release tablets of Olmesartan medoxomil were prepared using
different quantities of HPMCK4M and Xanthan Gum in combinations by direct
compression technique. The concentration of Polymers, HPMCK4M 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.
Results: Nine formulations were prepared and are evaluated for various
pharmacopoeial tests. 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% HPMCK4M and 15% Xanthan gum, is the most identical formulation (similarity
factor f2
= 91.979, dissimilarity factor f1
= 1.546 & No significant difference, t=0.0338)
to marketed product (BENICAR). 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).
Novel drug delivery system, nanoparticles, resealed erythrocytes, niosomes, microspheres. It also contains information about virus, bacterias and their removal methods and sterility methods.
Nepal Pharmacy Council Model Questions with Answer keysBashant Kumar sah
MCQS, most probable questions compiled from the GPAT old exam questions, old council and LokSewa questions, pharmacology, jurisprudence, pharmaceutics, pharmacognosy, chemistry, hospital pharmacy.
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
it is about ideas and tips on how to write scientific writings like review, research articles papers as well as grants writing. its the preliminary things to know before the start to publish article.
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
2 Case Reports of Gastric Ultrasound
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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!
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Formulation and evaluation of folding film in a capsule for gastroretentive drug delivery system of losartan potassium
1. ISSN 2395-3411 Available online at www.ijpacr.com 1
International Journal of Pharma And Chemical Research I Volume 6 I Issue 1 I Jan – Mar I 2020
____________________________________________________________Research Article
FORMULATION AND EVALUATION OF FOLDING FILM IN A CAPSULE FOR
GASTRORETENTIVE DRUG DELIVERY SYSTEM OF LOSARTAN POTASSIUM
Bashant kumar sah*, CSR. Lakshmi, Rama Bukka and Siddhesh S Patil
Department of pharmaceutics, Nargund College of pharmacy,
II Main, Dattatreya Nagar, Banshankari III Stage, Banglore, Karnataka, India.
__________________________________________________________________
ABSTRACT
The main objective of the present study was to prepare the gastro retentive sustained release films enclosed in a capsule.
Sustained release films constitute an innovative dosage form that overcomes the problems of frequent dosing and
provides a sustained action for a longer period of time and has more gastric retention time due to its flat surface. Design
expert 11 trial version has been used for the optimization of formulation by taking amount of ethyl cellulose, amount of
PEG and concentration of coating solution of ethyl cellulose in % w/v. as factor A, B and C respectively at two levels
which are responsible for the drug release. Sustained release films were prepared by solvent casting method using
different polymers like HPMC K4M, HPMC K100M, HPMC 50cps, Ethyl cellulose, and PEG as the plasticizer. The
prepared sustained release films were evaluated for various evaluating parameters. The selected formulations were
subjected to stability studies at 40 ± 2°C and 75 ± 5% RH for 30 days. All the formulations showed low weight variation
with sustained release of drug. The physical properties like tensile strength, folding endurance, and drug content of all
the formulations were within the acceptable limits. Sustained release films showed no change in appearance, drug
content and dissolution profiles.
Keywords: sustained release film, losartan potassium, gastro retentive, polymers, solvent casting method.
INTRODUCTION
High blood pressure is a major independent risk
factor for cardiovascular disease and stroke;
Indeed 5.8% of all deaths are directly linked with
hypertension. All in all, hypertension is one of
the five chronic diseases (psychological
illnesses, diabetes, heart disease, asthma),
which are responsible for half the expenditure of
the health systems.
1
Oral drug delivery systems
are more convenient and commonly used
method of drug delivery system and are
generally considered ideal drug delivery system.
Oral route is considered most natural,
uncomplicated, convenient and safe due to its
ease of administration, patient acceptance, and
cost-effective manufacturing process.
2
The
objective of this study is to develop the ideal
drug delivery system which will perform as the
sustained delivery of drug for the treatment of
hypertension. The film in a capsule has a
number of advantages of over conventional drug
delivery system such as improved efficiency,
reduced toxicity, single dose therapy and
improved patient compliance.
3
The drugs which
are locally active in the stomach, have an
absorption window in the stomach or in the
upper small intestine.
4
They are unstable in the
intestinal or colonic environment, or exhibit low
solubilities at high pH values.
5
These limits,
promote the development of gastroretentive
drug delivery systems (GRDDSs).
Factors affecting GRDDS performance
Formulation factors
The shape of the dosage form is one of the
factors that affect its GRT. Six shapes (ring,
tetrahedron, cloverleaf, string, pellet, and disk)
were screened in-vivo for their gastric retention
potential.
6
In the case of floating systems,
formulation variables such as the viscosity grade
of the polymers and their interactions
significantly affect floating properties of the
delivery system and drug release. Low-viscosity
polymers (e.g., HPMC K100 LV) were found to
be more beneficial than high-viscosity polymers
(e.g., HPMC K4M) in improving floating
properties. In addition, a decrease in the release
rate was observed with an increase in polymer
viscosity.
7
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International Journal of Pharma And Chemical Research I Volume 6 I Issue 1 I Jan – Mar I 2020
Idiosyncratic factors
The concomitant intake of food and drugs such
as anti-cholinergic (e.g., atropine or
propantheline), opiates (e.g., codeine) and
prokinetic agents (e.g., metoclopramide and
cisapride), may affect the performance of
GRDDS. The co-administration of GI motility–
decreasing drugs can increase gastric emptying
time. On the contrary, these drugs should be
contraindicated with mucoadhesive systems
because they reduce gastric secretion and
induce the drying of mucus membranes.
8
Biological factors such as gender, age, posture,
body mass index, and disease state (e.g.,
diabetes or Crohn’s disease) may also affect
gastroretention. For example, women and the
elderly show slower gastric emptying than do
men and younger subjects. Floating forms
appear to be equally likely to remain buoyant
anywhere between the lesser and greater
curvatures of the stomach. On moving distally,
these units may be swept away by the
contractile waves that propel the gastric
contents towards the pylorus, leading to
significant reduction in GRT compared with
upright subjects. Therefore, patients preferably
should not be dosed with a floating drug delivery
system just before going to bed.
9
Optimisation
was done by 2
3
full factorial design by using
design expert trial version 11.
10
MATERIALS AND METHODS
Materials
Losartan potassium was obtained as the gift
sample from Indoco Remedies Limited Mumbai
400098, India. Analytical grade solvents,
Ethylcellulose, Eudragit and HPMC (Hydroxy
propyl methyl cellulose) of different grade were
purchased from S.D.Fine chem Pvt. Ltd,
Mumbai.
Method
Solvent casting method was followed to
manufacture the sustained release film of
losartan potassium. All the polymers selected,
drug and excipients were passed through sieve
no.60 before using into formulation. Polymers
selected for expandable films are: HPMC 15cps,
HPMC 50cps, HPMC K100M, HPMC K4M,
Eudragit L100, Ethyl cellulose, and Polyethylene
glycol.
Steps involved in the manufacture of
sustained release films in a capsule
1. First the drug, polymer and other excipients
selected were passed through 60-mesh
sieve.
2. Required quantity of drug, polymer and
excipients were weighed properly and
transferred into 20 ml beaker and equal
mixture of ethyl alcohol and chloroform
were added to it with constant stirring
3. The solution was casted in a petri dish
which is 38.5 cm
2
and kept for drying for 24
hours at room temperature.
4. Then coating of ethyl cellulose is done to
the films formed and dried.
5. The formed films were cut into smaller films
of 3cm x 3cm size then folded in zigzag
fashion and enclosed in 0 size capsule.
11
Optimization
Optimization was done by using Design-Expert
11 trial version software. Total 8 batches were
prepared by applying 2
3
factorial design subtype
randomized with 0 center points. All the batches
were evaluated and different polynomial
equations were derived for Cumulative % drug
release at 2 hours (Q2), 6 hours (Q6) and 8
hours (Q8). The statistical analysis of the
factorial design batches was performed by
ANOVA using Design-Expert 11 trial version
software.
Table 1: The 2
3
randomized factorial design of formulation with the responses
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International Journal of Pharma And Chemical Research I Volume 6 I Issue 1 I Jan – Mar I 2020
EVALUATION OF SUSTAINED RELEASE
FILMS
1. Weigh variation of Films
Sustained release expandable films were
weighed on analytical balance and average
weight can be determined for each film. It is
desirable that films should have nearly constant
weight. It is useful to ensure that a film contains
the proper amount of API and excipients.
2. Thickness of Films
By using vernier caliper the thickness of the film
was measured at three different places and
average of was calculated. This is essential to
ascertain uniformity in the thickness of the film
this is directly related to the accuracy of the
dose in film.
3. Folding Endurance
Folding endurance is measured by manual
repeated folding of the film at the same place till
it breaks. The number of times the film is folded
without breaking is known as the folding
endurance value.
12
4. Tensile strength
Tensile strength is the maximum stress applied
to a point at which the strip specimen breaks. It
is calculated by applied load at rupture divided
by the cross sectional area of the strip as given
in the following equation
12
Tensile strength = Load at failure × 100/film
thickness × film width
5. Percent Elongation
When stress is applied to a film sample it
stretches and this is referred as strain. Strain is
basically the deformation of film divided by
original dimension of the sample. Generally
elongation of film increases as the plasticizer
content increases.
% Elongation = Increase in length× 100/
Initial length of film
6. Drug content uniformity
This is determined by any standard assay
method described for the particular API in any of
the standard pharmacopoeia. Content uniformity
is determined by estimating the API content in
individual strip. Limit of content uniformity for
losartan potassium is 98.5%-101.5%.
7. Surface pH
The film to be tested was placed in a petri dish
and was moistened with 0.5 ml of distilled water
and kept for 30 seconds. The pH was noted
after bringing the electrode of the pH meter in
contact with the surface of the formulation and
allowing equilibration for 1 min. The average of
three determinations for each formulation was
done.
13
8. Dissolution test
Dissolution test was performed using USPXXII
dissolution apparatus-II. 900 ml of pH 1.2 buffer
was used as dissolution medium. The
temperature was maintained at 37 ± 0.5℃.
Rotation of the paddle speed was kept at 50 rpm
which simulates the peristaltic movement of the
gastro-intestinal tract.
RESULTS
Table 2: Standard calibration curve of Losartan potassium in pH 1.2 buffer
S. No. Concentration (µg/ml) Average Absorbance in pH 1.2 buffer
(N=6)
1. 3 0.416±0.022361
2. 6 0.7214±0.079598
3. 9 1.0132±0.091489
4. 12 1.2986±0.119486
5. 15 1.7578±0.151584
6. 18 2.0794±0.184275
7. 21 2.388±0.196628
8. 24 2.7342±0.231642
9. 27 3.0296±0.28133
10. 30 3.2452±0.235379
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International Journal of Pharma And Chemical Research I Volume 6 I Issue 1 I Jan – Mar I 2020
Fig. 1: Standard graph of losartan potassium by 2
nd
derivative in pH 1.2 buffer
Table 3: Results of various evaluating parameters of Drug and formulation R1 to R8
Table 4: In-vitro dissolution studies profile of R1 to R8 formulations
Run
Amount of ethyl
cellulose (mg)
Wt. of the film
(Gram)
Thickness
(mm)
Folding
endurance
Tensile strength
(kg/mm2
)
%elongation
(%)
% drug
content
Surface
pH
1 50 0.341 ± 0.019 0.20 ± 0.007 >150 5.140 ± 0.041 5.640 ± 0.049 98.40±0.22 7.1±0.12
2 100 0.470 ± 0.012 0.28 ± 0.005 >150 6.091 ± 0.050 6.667 ± 0.044 98.86±0.24 7.0±0.13
3 50 0.353 ± 0.015 0.21 ± 0.007 >150 5.011 ± 0.048 4.801 ± 0.050 97.45±0.25 6.9±0.12
4 100 0.467 ± 0.014 0.27 ± 0.007 >150 5.901 ± 0.052 6.680 ± 0.051 98.52±0.20 6.8±0.11
5 50 0.356 ± 0.016 0.21 ± 0.009 >150 5.120 ± 0.048 4.750 ± 0.041 98.12±0.21 6.7±0.13
6 100 0.451 ± 0.011 0.29 ± 0.003 >150 6.078 ± 0.051 6.640 ± 0.043 98.36±0.23 7.2±0.11
7 100 0.468 ± 0.013 0.30 ± 0.005 >150 6.041 ± 0.056 6.560 ± 0.053 98.45±0.27 7.1±0.13
8 50 0.364 ± 0.018 0.22 ± 0.009 >150 4.750 ± 0.049 5.401 ± 0.046 98.12±0.28 7.0±0.12
Time %Cumulative Drug Release
Hrs R1 R2 R3 R4 R5 R6 R7 R8
1. 13.481±0.052 5.458±0.326 10.245±0.312 4.3476±1.128 7.568±0.820 1.951±0.085 6.214±0.448 7.355±0.764
2. 14.276±0.098 7.605±0.790 15.513±0.746 9.182±1.002 3.130±0.374 5.102±0.504 10.052±1.012 19.610±0.833
3. 21.636±0.728 15.425±0.618 24.254±0.381 12.082±0.138 22.760±1.077 9.126±0.320 16.254±0.379 19.577±1.401
4. 27.335±0.299 20.143±0.064 34.214±0.966 16.340±0.498 28.474±0.636 14.578±0.631 24.158±0.400 26.472±0.858
6. 36.321±0.502 22.562±0.021 52.905±1.249 21.417±0.572 37.397±0.634 20.567±0.647 31.641±1.108 41.214±1.357
8. 41.830±0.020 34.214±0.007 61.235±0.350 38.562±0.654 49.451±0.668 31.215±0.509 43.124±0.516 56.854±1.973
12. 51.555±0.767 46.979±0.106 75.125±0.197 49.254±1.072 62.354±0.706 45.254±0.562 63.713±1.312 77.254±0.338
16. 55.908±1.433 60.456±0.790 86.235±0.674 60.245±1.301 75.558±0.753 61.021±0.219 81.249±0.698 80.125±0.890
20. 88.278±1.589 86.196±0.497 91.124±0.193 75.388±0.895 89.458±0.853 76.325±1.228 95.038±0.998 95.152±0.838
24. 90.688±0.660 95.674±2.007 100.125±1.414 87.245±1.400 101.245±0.987 90.214±1.458 100.838±1.361 97.659±1.077
0.416
0.7214
1.0132
1.2986
1.7578
2.0794
2.388
2.7342
3.0296
3.2452
y = 0.1098x + 0.0508
R² = 0.9976
0
0.5
1
1.5
2
2.5
3
3.5
4
0 5 10 15 20 25 30 35
absorbance
concentration in ug/ml
STANDARD GRAPH OF LOSARTAN POTASSIUM BY 2ND
DERIVATIVE IN pH 1.2 BUFFER
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International Journal of Pharma And Chemical Research I Volume 6 I Issue 1 I Jan – Mar I 2020
Fig. 2: Dissolution profile comparision of R2, R4, R6 and R7
Fig. 3: Dissolution profile comparision of R1, R3, R5 and R8
Fig. 4: Contour plot showing drug release at 8
th
hour from design expert of optimised formulation
0
20
40
60
80
100
120
0 5 10 15 20 25 30
CUMULATIVE%DRUG
RELEASED
TIME IN HOUR
r2 R4 R6 R7
0
20
40
60
80
100
120
0 5 10 15 20 25 30
CUMULATIVE%DRUG
RELEASED
TIME IN HOUR
R1 R3 R5 R8
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International Journal of Pharma And Chemical Research I Volume 6 I Issue 1 I Jan – Mar I 2020
Fig. 5: 3D Response surface methodology graph showing drug release at 8
th
hour from design
expert of optimised formulation
DISCUSSION
1. Weigh variation of Films
Individual weight of 3 films each containing 1
dose of the drug from each formulation was
taken and weighed. The films R1 to R8 varies
from 0.3415 ± 0.019122 gm to 0.4705 ±
0.012503 gm. This variation is due to the
amount of ethyl cellulose used in the
formulation, as the drug and other polymers
have been kept constant.
2. Thickness of Films
The thickness of the various film formulations
were measured using vernier calipers. The
average thickness of the films R1 to R8 were
found 0.2175 ± 0.007071 mm to 0.28375 ±
0.007071 mm. This variation is due to the
amount of ethyl cellulose used in the
formulation, as the drug and other polymers
have been kept constant.
3. Folding Endurance
Folding endurance of the films R1 to R8 was
found to be >150, hence the films were found to
be of appropriate strength, due to the presence
of PEG as the plasticizer in adequate amount
which prevents the breakdown at the folding
point as PEG provides flexibility to the films,
otherwise the film tends to get brittle.
4. Tensile strength
Tensile strength of the films R1 to R8 was found
to be 4.750 ± 0.049 kg/mm
2
to
6.099±0.05 kg/mm
2
as ethyl cellulose and PEG
in the formulations give more strength to the film
due to the increase in viscosity and elasticity in
the formulation.
5. Percent Elongation
Percentage elongation of the films R1 to R8 was
found to be 4.750 ± 0.041 to 6.667 ± 0.044.
Variation in percentage elongation occurred due
to the variation in amount of PEG and
concentration of coating solution used in the
formulations.
6. Drug content uniformity
The drug content of the films R1 to R8 was
found to be 97.45 % to 98.86 %, which was
uniform. There is not much deviation in the drug
content as the procedure of solvent casting
method does not involve any drug losses like
other methods of film forming.
7. Surface pH
The surface pH of the films R1 to R8 was found
to be 6.7 to 7.2, which is neutral in pH, as the
aqueous solution of ethyl cellulose shows
neutral pH.
8. Dissolution test
Dissolution testing was performed using the
standard paddle apparatus USP type-2
apparatus. The dissolution medium was 900ml
of pH 1.2 buffer which simulates the gastric
environment relating volume and pH
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International Journal of Pharma And Chemical Research I Volume 6 I Issue 1 I Jan – Mar I 2020
respectively. The temperature was maintained at
37±0.5℃. Rotating speed was maintained at 50
rpm. Mainly the dissolution behavior has been
evaluated by using the design expert software
trial version 11, from statistical ANOVA
evaluation the dissolution behavior at 2
nd
hour,
shows significant as P-value is 0.0376 which is
less than 0.0500 and R
2
is 0.8548 adjusted R
2
value 0.7458 and predicted R
2
0.4190 Adequate
Precision measures the signal to noise ratio,
which was greater than 4 i.e. 6.401 indicates an
adequate signal hence the model was applied to
navigate the design space. From the coded
equation it shows that the factor A is (-3.82)
times negative which means the % drug release
is inversely proportional to the factor A which is
amount of EC present in the formulation so on
increasing concentration of ethyl cellulose, the
% drug release was decreased at 2
nd
hour. Ethyl
cellulose acts as the sustained release polymer
and hydrophobic in nature so the drug enclosed
within this polymer could not get easy access to
the pH 1.2 buffer which is aqueous in nature.
According to Percolation Theory, when a matrix
is composed of a water soluble drug and a water
insoluble polymer, drug release occurs by
dissolution of the active ingredient through
capillaries composed of interconnecting drug
particle clusters and the pore network.
14
As drug
release continues, the interconnecting clusters
increase the pore network through which interior
drug clusters can diffuse. The total number of
ethyl cellulose particles increases when its
particle size is reduced. With more ethyl
cellulose particles present, the theory predicts
that fewer clusters of soluble drug substance are
formed. Furthermore, the presence of finite drug
clusters (encapsulated drug particles) is more
statistically plausible. The resulting pore network
becomes less extensive and more tortuous
resulting in slower drug release.
15
For the factor
B, it is +1.39 times positive which shows
increased % drug release values on increasing
the amount of PEG as it is hydrophilic plasticizer
so in aqueous medium it promotes more
solubility of drug from the formulation which
happens as the elongation of blended films
increased with increasing plasticizer contents,
but at high plasticizer contents there was
decreases in both tensile strength and modulus
which makes the film more accessible for
aqueous medium to penetrate the polymer-drug
mesh and drug releases more. For factor C, it is
-0.1604 times negative on % w/v of EC coating
solution which showed decreased % drug
release on increasing the concentration of EC
coating solution. Coating with Ethyl cellulose
acts as the barrier to penetrate the aqueous
medium to the formulation and increases the
time for the dissolution of drug into the medium.
Hence coating with ethyl cellulose decreases the
% drug release. Similarly drug release at 6
th
and
8
th
hour was found to be significant and release
behavior was similar at 2
nd
hour.
CONCLUSION
Gastro retentive sustained release films in
capsules were formulated using HPMC K100M,
HPMC K4M, Ethyl cellulose, HPMC 50cps, and
PEG as a plasticizer by solvent casting method
were found to be good. The drug content was
uniform in all the formulations of the films
prepared. The low values of standard deviation
indicate uniform distribution of drug within the
polymer matrices. The drug-polymer ratio was
found to influence the release of drug from the
formulation. As the polymer level was increased,
the drug release rates were found to decrease in
a sustained manner. The drug release was also
influenced by the concentration of coating
solution of the films. As the concentration of
coating polymer increased, release of the drug
decreased. The results obtained from design
expert software version 11 in the form of contour
plot, 3D-plot and cuboidal graph clearly shows
that increase in the factor A i.e. amount of ethyl
cellulose and the factor C decreases the drug
release and increase in the factor B increases
the drug release. Amount of PEG has influence
on release and tensile strength of the sustained
release films, drug release increased and tensile
strength decreases with increase in amount of
PEG as a plasticizer. The mechanism of the
drug release for the optimized formulation R2
was found to be Non-Fickian transport with Zero
order release. Formulations R1, R4 and R6
showed comparatively less drug release with
optimized formulation R2 at 24 hours.
ACKNOWLEDGEMENT
Authors are thankful to Nargund college of
Pharmacy, Bangalore, for giving us the
opportunity and providing necessary facilities in
to carry out this work.
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