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
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