Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
Computational modelling of drug disposition lalitajoshi9
computational modelling of drug disposition is the integral part of computer aided drug design. different kinds of tools being used in the prediction of drug disposition in human body. This topic in the CADD explains the details about the drug disposition, active transporters and tools.
This presentation involves the information about Modified-Release Drug Products, Targeted Drug Delivery Systems and Biotechnological Products in Pharmaceutics
Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
Computational modelling of drug disposition lalitajoshi9
computational modelling of drug disposition is the integral part of computer aided drug design. different kinds of tools being used in the prediction of drug disposition in human body. This topic in the CADD explains the details about the drug disposition, active transporters and tools.
This presentation involves the information about Modified-Release Drug Products, Targeted Drug Delivery Systems and Biotechnological Products in Pharmaceutics
REGULATORY AND INDUSTRY VIEWS ON QbD, SCIENTIFICALLY BASED QbD- EXAMPLES OF A...Ardra Krishna
The pharmaceutical Quantity by Design (QbD) is a systemic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quantity risk management.
QbD has been adopted by U.S Food and Drug Administration (FDA) for the discovery, development and manufacture of drugs.
Quality- by- design (QbD) is a concept introduces by the International Conference on Harmonization (ICH) Q8 guidelines.
This PPT includes what role does Dosage form impart on absorption. Why it is important in absorption. what should be its nature and type of dosage form.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
Myself Omkar Tipugade , M- Pharm ,Sem - II, Department of pharmaceutics , from Shree Santkrupa College Of Pharmacy , ghogaon . Today I upload presentation on Active Transport like P-gp , BCPR, Nucleoside transporters etc .
Computational modeling of drug dispositionPV. Viji
Computational modeling of drug disposition , Modeling techniques , Drug absorption , solubility , intestinal permeation , Drug distribution , Drug excretion , Active Transport , P-gp , BCRP , Nucleoside transporters , hPEPT1 , ASBT , OCT , OATP , BBB-choline transporter
FORMULATION FACTORS EFFECTING BIOAVAILABILITY OF DRUGSN Anusha
Bioavailability means the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action.
When the drug is given orally, only part of the administered dose appears in the plasma.
By plotting plasma concentrations of the drug versus time, one can measure the area under the curve (AUC).
This curve reflects the extent of absorption of the drug.
REGULATORY AND INDUSTRY VIEWS ON QbD, SCIENTIFICALLY BASED QbD- EXAMPLES OF A...Ardra Krishna
The pharmaceutical Quantity by Design (QbD) is a systemic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quantity risk management.
QbD has been adopted by U.S Food and Drug Administration (FDA) for the discovery, development and manufacture of drugs.
Quality- by- design (QbD) is a concept introduces by the International Conference on Harmonization (ICH) Q8 guidelines.
This PPT includes what role does Dosage form impart on absorption. Why it is important in absorption. what should be its nature and type of dosage form.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
Myself Omkar Tipugade , M- Pharm ,Sem - II, Department of pharmaceutics , from Shree Santkrupa College Of Pharmacy , ghogaon . Today I upload presentation on Active Transport like P-gp , BCPR, Nucleoside transporters etc .
Computational modeling of drug dispositionPV. Viji
Computational modeling of drug disposition , Modeling techniques , Drug absorption , solubility , intestinal permeation , Drug distribution , Drug excretion , Active Transport , P-gp , BCRP , Nucleoside transporters , hPEPT1 , ASBT , OCT , OATP , BBB-choline transporter
FORMULATION FACTORS EFFECTING BIOAVAILABILITY OF DRUGSN Anusha
Bioavailability means the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action.
When the drug is given orally, only part of the administered dose appears in the plasma.
By plotting plasma concentrations of the drug versus time, one can measure the area under the curve (AUC).
This curve reflects the extent of absorption of the drug.
Rate limiting steps in drug absorption [autosaved]Nagaraju Ravouru
Rate limiting steps in drug absorption 1.Disintegration time
2.Dissolution and solubility
3.Physical and chemical nature of active drug substance
4.Nature of excipients
5.Method of granulation
6.Dissolution test conditions
7.Gastric emptying
For better view, kindly download the presentation. The presentation contains information about absorption of drug and various mechanisms which plays role in drug absorption. Additionally it includes factors affecting drug absorption.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
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This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
Ethnobotany and Ethnopharmacology:
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Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
ROLE OF DOSAGE FORM IN GASTRO-INTESTINAL ABSORPTION
1. ROLE OF DOSAGE FORM
IN GASTRO-INTESTINAL
ABSORPTION
ANKIT KUMAR MALIK
M.PHARMACY 2nd sem
DEPARTMENT OF PHARMACEUTICS
SPER , JAMIA HAMDARD
1
2. INTRODUCTION
A drug injected intravascularly directly enters the systemic circulation and exerts its
pharmacological effects. But Majority of drugs administered extravascularly
(orally).
If intended to act systemically, such drugs can exert their pharmacological actions
only when they come into blood circulation from their site of application.
So, absorption is an important step.
ABSORPTION :- Movement of active drug (or prodrug) from the site of
administration to the systemic circulation.
2
3. . Drug formulations are designed to provide an attractive, stable, and convenient
method to use products.
Conventional dosage forms may be broadly characterized as;
SOLUTIONS
SUSPENSION
CAPSULES
TABLETS
The bioavailability of a drug to decrease in the following order:
solution > suspension > capsule > tablet> coated tablet
One drug can routinely produce a 2 to 5-fold difference in the rate or extent of
gastro-intestinal absorption depending on the dosage form of the formulation.
In some cases, even greater difference observed. A difference of more than 60-fold-
has been found in the absorption rate of spironolactone from the worst formulation to
the best formulation.
3
4. NATURE AND TYPE OF DOSAGE
FORM:
4
In the following figure, the stages in drug abs. from the various dosage form, has been illustrated
5. SOLUTIONS
Solutions such as syrups and elixirs show fast and often complete absorption of drug
because they do not have dissolution problem.
However, dilution of the drug solution with gastric fluid may result in precipitation that
may re-disperse rapidly due to extremely fine nature of precipitate.
The factors that affect drug absorption from solution include viscosity, reversible
complexation , chemical stability and micellar solubilization.
The vehicle used in syrups , elixirs and emulsions may be aqueous or non-
aqueous(e.g., PEG, PG, alcohol ) or non-water miscible(e.g., vegetable oils).
The rate of drug absorption from non-aqueous or non-water miscible vehicle based
solution is less than the rate of drug absorption from water based solution.
5
6. .
The selection of vehicle for solution dosage form depends on the physiochemical
properties of the drug.
Ex. Paracetamol drop is prepared with PEG 400 as it is sparingly soluble in water.
Certain materials such as sorbitol or hydrophilic polymers are added to a solution
dosage form, to improve pourability and palatability by increasing the viscosity of
the preparation.
Due to good systemic availability, solutions are frequently used as bioavailability
standards against which other dosage forms are compared.
6
7. .
Rapid and complete absorption may be observed in some instances, particularly if
the oil is administered in emulsified form.
Administration of indoxole dissolved in the oil phase of Lipomul-Oral(o/w).
Resulted in a three fold improvement in the extent of absorption compared to that
observed after administration of an aqueous suspension and a nine fold
improvement compared to a hard gelatin capsule.
7
8. SUSPENSIONS
Drug in a suspension is in solid form, but is finely divided and has a large surface
area. Drug particles can diffuse readily between the stomach and small intestine so that
absorption is relatively insensitive to stomach emptying rate.
Adjusting the dose to a patient’s needs is easier with solutions and suspensions than
with solid dosage forms.
Several studies have demonstrated the superior bioavailability characteristics of
suspensions compared to those of solid dosage forms.
Ex. the blood levels of trimethoprim and sulfamethoxazole were compared in 24 healthy
subjects following oral administration of 3 forms, The absorption rate of each drug was
significantly greater with the suspension than with the tablet or capsule.
Penicillin blood conc. following oral administration of various dosage forms show higher level
with suspension of Phenoxymethyl penicillin
8
9. .
Finally divided solid particles in suspension are stabilized with suspending agents.
Suspending agents retard the rate sedimentation of dispersed particles.
Absorption of drug in suspension form is not greatly affected by stomach emptying
rate.
But suspending agent may increase the viscosity of drug vehicle and thereby may
diminish rate of drug dissolution.
Other critical factors that affect drug absorption include particle size, crystal forms
and formation of non-absorbable complexes
Suspending agent may form non-absorbable complexes with drug eg., divalent
metals form in suspension of multivitamins and essentials elements form complex
with sodium carboxymethylcellulose that poorly get absorb in body.
As dissolution is taking place at the surface of solute smaller particle having larger
surface area may dissolve rapidly.
9
10. . Bioavailability studies with drugs suspended in oi1-in-waier emulsions have yielded
some promising results.
One study compared the absorption of micronized griseofulvin after its
administration to healthy subjects in a corn oil-in-water emulsion, an aqueous
suspension, and two different commercial tablets.
The extent of absorption of the drug after administration of the emulsion
was about twice that observed after administration of the aqueous suspension or
tablets.
MOA ; based on the ability of fatty acids, liberated during the digestion of corn oil,
to inhibit gastrointestinal motility (which would increase the residence time of the
drug in the small intestine) and to stimulate gallbladder evacuation
10
11. CAPSULES
In capsule on disruption of the shell, the encapsulated powder mass should disperse
rapidly to expose a large surface area to the gastrointestinal fluids.
Diluents added to capsules dosage form may affect the dissolution of filled drug in
capsule shell.
Hydrophilic diluents are added in the capsule of a poorly water soluble drugas they
enhance the dispersion rate of the aqueous fluid to the contents of the shell.
This results in better dissolution of the drug in the biological fluid.
Sometimes wetting agents are also added to improve dispersion rate
11
12. .
Further, drug absorption from capsule may also be affected by particle size and
chemical and physical incompatibility of the drug with a filler and other ingredients.
Certain drugs are formulated in soft gelatin capsule as a solution from which drug
disperses and dissolves more rapidly as compared to hard gelatin capsule.
Moreover, soft gelatin capsule leaves less residual drug in gut and hence causes
minimal irritation.
This approach is more useful for the drugs that causes local irritation
12
13. .
The use of dicalcium phosphate as a diluent in tetracycline capsules has been
found to significantly impair absorption because a poorly soluble calcium-
tetracycline complex is formed in the powder mass or during dissolution.
Factors that influence drug absorption from capsule dosage forms includ- particle
size and crystal form of the drug, and selection of diluents and fillers.
A soft elastic capsule containing 0.4 mg of digoxin is about equivalent to a tablet
containing 0.5 mg of the drug i.e; mean absorption was 75% of the dose from the
tablet and 97% from the capsule.
14
15. . Many factors related to the formulation or production of tablets may affect drug
dissolution and absorption.
Most formulations require the incorporation of hydrophobic lubricants, such as
magnesiurn stearate, to produce an acceptable tablet. In general, the larger the
quantity of lubricant in a formulation the slower is the dissolution rate.
Compression force may also be an important factor in drug bioavailability from
compressed tablets.
The in vitro disintegration time of tablets has been shown to be directly
proportional to compression force and tablet hardness.
High compression forces may also increase the strength of the internal structure of
the granules and retard dissolution of drug from the granules and disintegration of
the granules.
16
16. .
A novel approach to enhance the availability of poorly water-soluble drugs from
tablets has been used in a marketed griseofulvin product.
A molecular dispersion of the drug in
polyethylene glycol 6000,
a water-soluble waxy polymer that congeals at about 60C,
is prepared and suitably modified for incorporated into a tablet dosage form.
The absorption of griseofulvin from this product appears to be complete and about
twice that observed from commercial tablets containing micronized drug.
17
17. COATED TABLET
The coating must dissolve or disrupt before tablet disintegration and drug dissolution can
occur.
The disintegration of certain coated tablets appears to be the rate-limiting process in drug
absorption.
Film-coated tablets are compressed tablets that are coated with a thin layer or film of a
material that is usually water soluble or dispersible.
A number of polymeric substances with film forming properties may be used including
hydroxypropyl methylcellulose and carboxymethylcellulose.
The film coat should disrupt quickly in the fluids of the gastrointestinal tract, independent
of pH.
Sugar coating may affect the bioavailability of a drug. Alternatives include the film-coated
tablet and the press coated tablet.
18
18. Enteric coated Tablets
Enteric coated is special film coated tablet which are used to bypass gastric fluid
so that the drug gets dissolve in intestine.
They show a delayed absorption and therefore a delayed onset of action.
They also show high inter and intra subject variability due to difference in gastric
emptying rate.
The modern approach to enteric-coating makes use of polymer like cellulose
acetate phthalate that are ''insoluble' at pH I to 3 but 'soluble" at pH5 to 7.
19
19. .
The thickness of the coating may also affect bioavailability.
Studies with quinine tablets coated with cellulose acetate phthalate show a
decrease in both rate and extent absorption with increasing thickness of the
coating.
20