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FLOATING DRUG DELIVERY SYSTEM: A NEW TOOL
PROJECT REPORT SUBMITTED TO
ARYABHATTA KNOWLEDGE UNIVERSITY, PATNA
In partial fulfilment of the award of the degree of the
BACHELOR OF PHARMACY
GOVERNMENT PHARMACY INSTITUTE PATNA,-07
Under the esteemed guidance of
Dr. Ram Kumar Choudhary, M.Pharm, Ph.D.
Principal
Presented by:-
Shweta Kumari
Reg.No-19109112009
Session -2019-2023
CONTENT
 Introduction
 Basic gastrointestinal tract physiology
 Approaches for prolonging gastric residence time
 Advantages and Disadvantages of FDDS
 Factors involved in Gastric Retentation
 Classification of FDDS
 Mechanism of Floating system
 Excipient used in FDDS
 Method of preparation
 Evaluation of FDDS
 Application
 Marketed product
 conclusion
ABSTRACT
In recent years scientific and technological advancements have been made in the
research and development of new drug delivery systems have been made by
resolving physiological disorders, such as short gastric residence periods and
unpredictable gastric emptying times. Gastro retentive Dosage forms
(GRDF)which will be hold within the stomach.
Introduction
• Floating drugs are gastro retentive systems which remain in gastro region for
several hours i.e. it prolong gastro residual time of drugs.
• FDDS enhance GRT( Gastro resistance time) and control fluctuation in plasma
drug concentration.
Need of FDDS( Floating drug delivery
system
• Gastric emptying time in humans avg (2-3 hrs) through
major absorption zone can result incomplete drug release
from drug delivery leads to administered dose efficacy.
• Beneficial in gastrointestinal diseases.
• Lower dosing and lesser side effects
Floating system
Basic gastro intestinal tract physiology
The stomach is anatomically divided into three regions:-
• FUNDUS- Proximal Part
• BODY - Act as a reservoir for undigested food
• PYLOROUS- Site of mixing
Stomach physiology
Mucous cell- Secrete alkaline fluid
Parietal cell -Secrete HCL acid
Chief cell- Secrete Pepsin a proteolytic enzyme
G-cells- Secrete the hormone gastrin
Gastric Emptying rate
• The dosage form’s shape
• Full or Empty stomach condition
• Meal Composition
• Density
• Size
• Quantities of calories in food
• Feeding schedule
• Gender
• Age
• Body posture
• Diseased conditions
Factors Involved In Gastric Retention
Advantages of Floating Drug Delivery System
 Enhanced Bioavailability
 Enhanced First Pass Biotransformation
 Sustained drug delivery /reduced frequency of Dosing
 Targated therapy for local ailments in the upper GIT
 Reduced Fluctuations of Drug Concentration
 Reduced counter activity of the body
 Extended time over Critical (Effective) concentration
 Improved Receptor activation selectivity
 Minimize adverse activity in the colon
 Site- specific Drug Delivery
 Pharmacokinetic advantages
Disadvantages of FDDS
 The drug substances that are unstable in the acidic environment
of the stomach are not suitable candidates to be incorporated
into the systems.
 These system require a high level of fluid in the stomach for drug
delivery to float and work efficiently.
 Not suitable for drugs that have solubility or stability problems in
GIT
Floating Drug
Delivery System
Effervescent
System
Gas generating
system
intragastric single
layer floating
tablets /
Hydrodynamically
Balanced System
Intragastric
Bilayered Floating
Tablets
Multiple
Unit Type
Floating
Pills
volatile
liquid/vaccum
system
Intragastric Floating
Gastrointestinal Drug
Delivery System
Inflatable
Gastrointestinal
Delivery Systems
Intragastric Osmotically
Controlled Drug
Delivery System
Non effervescent
system
single layer
floating tablets
Bilayer
Floating
Tablets
Alginate
beads
Hollow
Microsphere
Raft forming
system
Classification of Floating Drug Delivery system based on the mechanism of buoyancy
Effervescent System
Use of gas-generating carbonates (citric acid, tartaric acid) to
produce CO2 gas and reduce the density of the system, this may let
them float.
Thus two subtypes of effervescent system are:-
• Gas Generating system
• Volatile Liquid/Vacuum-containing system.
Non- effervescent systems:-
• Based on the mechanism of polymer swelling or bioadhesion to the GI tract mucosal
layer.
• Gel-forming or highly swellable cellulose types of hydrocolloids, polysaccharides and
matrix-forming materials such as polycarbonate, polymethacrylate, and polyacrylate are
used.
Types of Non-effervescent system
• Bilayer Floating tablets
• Single-layer floating tablets
• Alginate Beads
• Hollow Microsphere Single-layer
Mechanism of Floating Drug Delivery System
F = F buoyancy - F gravity = (Df - Ds) gV
Where, F= total vertical force,
Df = fluid density,
Ds = object density, V = volume
g = acceleration due to gravity
FDDS has a bulk density less than gastric fluids
and so remain buyont in the stomach without
affecting the gastric emptying rate for prolonged
period of time.
RAFT-FORMING SYSTEM
• This system is used for the delivery of antacids and drug delivery for the treatment of
gastrointestinal infections and disorders.
• The mechanism involved in this system includes the formation of a viscous cohesive gel
in contact with gastric fluids, forming a continuous layer called a raft.
Barrier formed by raft-forming system
Polymers used in the formulation of FDDS
• Innert fatty materials wax, fatty acids, long chain fatty alcohols
• Hydrocolloids:-HPMC1000, HPMC 4000, Sodium alginate
• Effervcent agent:-Sodium bicarbonate,citric acid ,tartaric acid.
• Release rate accelerants-Lactolose, Mannitol
• Release rate retardants-Dicalcium phosphate, talc
• Buoyancy increasing agent-Ethyl cellulose
Methods of preparations
Solvent evaporation method
Ionotropic Gelatine method
Emulsion solvent diffusion
method
EVALUATION TESTS:-
 Angle of Repose
 Bulk Density
 Percentage porosity
 Buoyancy capabilities
 In vitro floating and dissolution behaviour
 Weight variations
 Hardness and friability
 Particle size analysis, and surface characterization.
 X-Ray /Gamma Scintigraphy
 Pharmacokinetic studies
In vitro Test Evaluations of Tablets
Application
Application of
Floating Drug
Delivery System
Enhance
Bioavailability
Minimize
Adverse
Activity At the
Colon
Reduced
Fluctuations
of Drug
Concentration
Absorption
Enhancement
Site-Specific
Drug Delivery
System
Sustained
Drug Delivery
Future- Potential of floating drug delivery system
• Floating drug delivery system is considered a beneficial strategy for the
treatment of gastric and duodenal cancers.
• The floating concept can also be utilized in the development of various anti-
reflux formulations.
• Developing a controlled release system for the drugs, which are potential to
treat Parkinson’s disease.
Marketed Product
s.no Doses Form Drugs Brand Name Company Country
1 Floating controlled
release capsule
Levodopa
Benserazide
Modapar Roche products USA
2 Floating Capsule Dizepam Valrelease Hoffmann USA
3 Effervescent floating
liquid alginate
preperation
Aluminium
hydroxide
Magnesium
hydroxide
LIQUID
GAVISON
GLAXO SMITH KLINE INDIA
4 Floating liquid
alginate preperation
Aluminium
Magnesium
antacid
TOPAKALAN Pierre Fabre Drug FRANCE
Conclusion
 FDDS promises to be a potential approach for gastric retention
 Dosage form with prolonged GIT will bring about new and important
therapeutic actions.
 These systems offer the gain of better absorption and bioavailability.
 Floating drug delivery system guarantees to be a technique for gastric
retention. Although there are a wide variety of complications to be laboured
out to gain extended GI retention.,
 many companies are focusing in the direction of commercializing this
approach.
 A wide variety of industrial product patents and recent research on Floating
drug delivery system are briefly studied here.
Reference:-
Ross and Wilson, book of Human Anatomy and physiology of health
education,12,285.2014
Snehal, Chaudhari*, Sheelpriya Walde, Anand Purohit, A Review on
Floating Drug Delivery Systems, nternational Journal of Pharmaceutical
Sciences Review and Research,37-41,8(1),2023
Haridwar Lodh*, Sheeba FR, Prabhat Kumar Chourasia, Harshitha Arun
Pardhe, Floating Drug Delivery System: A Brief Review, American journal of
Pharmaceutical Research, 104-22,10(4),2020
Prachi Dewangan, Rudra Pratap Singh Rajput, Lata Patel, Durga Sahu,
Recent Research and Approaches on Floating Drug Delivery System-A
Review, International Journal of All Research Education and Scientific
Method ,334-349,9(2),2021
[31] Gadge G. Gunjan, Gastro Retentive Floating Drug Delivery System: An
Overveiw, Research Journal of Pharmaceutical Dosage Forms and
Technology, 125-130 12(03), 2020
Floating Drug Delivery System A New Tool

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Floating Drug Delivery System A New Tool

  • 1. FLOATING DRUG DELIVERY SYSTEM: A NEW TOOL PROJECT REPORT SUBMITTED TO ARYABHATTA KNOWLEDGE UNIVERSITY, PATNA In partial fulfilment of the award of the degree of the BACHELOR OF PHARMACY GOVERNMENT PHARMACY INSTITUTE PATNA,-07 Under the esteemed guidance of Dr. Ram Kumar Choudhary, M.Pharm, Ph.D. Principal Presented by:- Shweta Kumari Reg.No-19109112009 Session -2019-2023
  • 2. CONTENT  Introduction  Basic gastrointestinal tract physiology  Approaches for prolonging gastric residence time  Advantages and Disadvantages of FDDS  Factors involved in Gastric Retentation  Classification of FDDS  Mechanism of Floating system  Excipient used in FDDS  Method of preparation  Evaluation of FDDS  Application  Marketed product  conclusion
  • 3. ABSTRACT In recent years scientific and technological advancements have been made in the research and development of new drug delivery systems have been made by resolving physiological disorders, such as short gastric residence periods and unpredictable gastric emptying times. Gastro retentive Dosage forms (GRDF)which will be hold within the stomach.
  • 4. Introduction • Floating drugs are gastro retentive systems which remain in gastro region for several hours i.e. it prolong gastro residual time of drugs. • FDDS enhance GRT( Gastro resistance time) and control fluctuation in plasma drug concentration. Need of FDDS( Floating drug delivery system • Gastric emptying time in humans avg (2-3 hrs) through major absorption zone can result incomplete drug release from drug delivery leads to administered dose efficacy. • Beneficial in gastrointestinal diseases. • Lower dosing and lesser side effects Floating system
  • 5. Basic gastro intestinal tract physiology The stomach is anatomically divided into three regions:- • FUNDUS- Proximal Part • BODY - Act as a reservoir for undigested food • PYLOROUS- Site of mixing Stomach physiology Mucous cell- Secrete alkaline fluid Parietal cell -Secrete HCL acid Chief cell- Secrete Pepsin a proteolytic enzyme G-cells- Secrete the hormone gastrin Gastric Emptying rate
  • 6. • The dosage form’s shape • Full or Empty stomach condition • Meal Composition • Density • Size • Quantities of calories in food • Feeding schedule • Gender • Age • Body posture • Diseased conditions Factors Involved In Gastric Retention
  • 7. Advantages of Floating Drug Delivery System  Enhanced Bioavailability  Enhanced First Pass Biotransformation  Sustained drug delivery /reduced frequency of Dosing  Targated therapy for local ailments in the upper GIT  Reduced Fluctuations of Drug Concentration  Reduced counter activity of the body  Extended time over Critical (Effective) concentration  Improved Receptor activation selectivity  Minimize adverse activity in the colon  Site- specific Drug Delivery  Pharmacokinetic advantages
  • 8. Disadvantages of FDDS  The drug substances that are unstable in the acidic environment of the stomach are not suitable candidates to be incorporated into the systems.  These system require a high level of fluid in the stomach for drug delivery to float and work efficiently.  Not suitable for drugs that have solubility or stability problems in GIT
  • 9. Floating Drug Delivery System Effervescent System Gas generating system intragastric single layer floating tablets / Hydrodynamically Balanced System Intragastric Bilayered Floating Tablets Multiple Unit Type Floating Pills volatile liquid/vaccum system Intragastric Floating Gastrointestinal Drug Delivery System Inflatable Gastrointestinal Delivery Systems Intragastric Osmotically Controlled Drug Delivery System Non effervescent system single layer floating tablets Bilayer Floating Tablets Alginate beads Hollow Microsphere Raft forming system Classification of Floating Drug Delivery system based on the mechanism of buoyancy
  • 10. Effervescent System Use of gas-generating carbonates (citric acid, tartaric acid) to produce CO2 gas and reduce the density of the system, this may let them float. Thus two subtypes of effervescent system are:- • Gas Generating system • Volatile Liquid/Vacuum-containing system.
  • 11. Non- effervescent systems:- • Based on the mechanism of polymer swelling or bioadhesion to the GI tract mucosal layer. • Gel-forming or highly swellable cellulose types of hydrocolloids, polysaccharides and matrix-forming materials such as polycarbonate, polymethacrylate, and polyacrylate are used. Types of Non-effervescent system • Bilayer Floating tablets • Single-layer floating tablets • Alginate Beads • Hollow Microsphere Single-layer
  • 12. Mechanism of Floating Drug Delivery System F = F buoyancy - F gravity = (Df - Ds) gV Where, F= total vertical force, Df = fluid density, Ds = object density, V = volume g = acceleration due to gravity FDDS has a bulk density less than gastric fluids and so remain buyont in the stomach without affecting the gastric emptying rate for prolonged period of time.
  • 13. RAFT-FORMING SYSTEM • This system is used for the delivery of antacids and drug delivery for the treatment of gastrointestinal infections and disorders. • The mechanism involved in this system includes the formation of a viscous cohesive gel in contact with gastric fluids, forming a continuous layer called a raft. Barrier formed by raft-forming system
  • 14. Polymers used in the formulation of FDDS • Innert fatty materials wax, fatty acids, long chain fatty alcohols • Hydrocolloids:-HPMC1000, HPMC 4000, Sodium alginate • Effervcent agent:-Sodium bicarbonate,citric acid ,tartaric acid. • Release rate accelerants-Lactolose, Mannitol • Release rate retardants-Dicalcium phosphate, talc • Buoyancy increasing agent-Ethyl cellulose
  • 15. Methods of preparations Solvent evaporation method Ionotropic Gelatine method Emulsion solvent diffusion method
  • 16. EVALUATION TESTS:-  Angle of Repose  Bulk Density  Percentage porosity  Buoyancy capabilities  In vitro floating and dissolution behaviour  Weight variations  Hardness and friability  Particle size analysis, and surface characterization.  X-Ray /Gamma Scintigraphy  Pharmacokinetic studies In vitro Test Evaluations of Tablets
  • 17. Application Application of Floating Drug Delivery System Enhance Bioavailability Minimize Adverse Activity At the Colon Reduced Fluctuations of Drug Concentration Absorption Enhancement Site-Specific Drug Delivery System Sustained Drug Delivery
  • 18. Future- Potential of floating drug delivery system • Floating drug delivery system is considered a beneficial strategy for the treatment of gastric and duodenal cancers. • The floating concept can also be utilized in the development of various anti- reflux formulations. • Developing a controlled release system for the drugs, which are potential to treat Parkinson’s disease.
  • 19. Marketed Product s.no Doses Form Drugs Brand Name Company Country 1 Floating controlled release capsule Levodopa Benserazide Modapar Roche products USA 2 Floating Capsule Dizepam Valrelease Hoffmann USA 3 Effervescent floating liquid alginate preperation Aluminium hydroxide Magnesium hydroxide LIQUID GAVISON GLAXO SMITH KLINE INDIA 4 Floating liquid alginate preperation Aluminium Magnesium antacid TOPAKALAN Pierre Fabre Drug FRANCE
  • 20. Conclusion  FDDS promises to be a potential approach for gastric retention  Dosage form with prolonged GIT will bring about new and important therapeutic actions.  These systems offer the gain of better absorption and bioavailability.  Floating drug delivery system guarantees to be a technique for gastric retention. Although there are a wide variety of complications to be laboured out to gain extended GI retention.,  many companies are focusing in the direction of commercializing this approach.  A wide variety of industrial product patents and recent research on Floating drug delivery system are briefly studied here.
  • 21. Reference:- Ross and Wilson, book of Human Anatomy and physiology of health education,12,285.2014 Snehal, Chaudhari*, Sheelpriya Walde, Anand Purohit, A Review on Floating Drug Delivery Systems, nternational Journal of Pharmaceutical Sciences Review and Research,37-41,8(1),2023 Haridwar Lodh*, Sheeba FR, Prabhat Kumar Chourasia, Harshitha Arun Pardhe, Floating Drug Delivery System: A Brief Review, American journal of Pharmaceutical Research, 104-22,10(4),2020 Prachi Dewangan, Rudra Pratap Singh Rajput, Lata Patel, Durga Sahu, Recent Research and Approaches on Floating Drug Delivery System-A Review, International Journal of All Research Education and Scientific Method ,334-349,9(2),2021 [31] Gadge G. Gunjan, Gastro Retentive Floating Drug Delivery System: An Overveiw, Research Journal of Pharmaceutical Dosage Forms and Technology, 125-130 12(03), 2020