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GASTRORETENTIVE DRUG DELIVERY
SYSTEM
Presented By:
Pranali M. Palandurkar
University department of
pharmaceutical sciences
R.T.M.N.U Nagpur
Contents
Introduction
Advantages
Disadvantages
Approaches
Application
2
INTRODUCTION
• Oral sustained drug delivery system is complicated by limited gastric residence time.
• Rapid gastrointestinal transit can prevent complete drug release in the absorption zone
and reduce the efficacy of administered dose, since the majority of drugs are absorbed in
stomach or the upper part of small intestine .
• Gastro-retentive delivery is one of the site specific delivery for the delivery of drugs
either at stomach or at intestine. It is obtained by retaining dosage form into stomach and
drug is being released at controlled manner to specific site either in stomach, duodenum
and intestine
• Floating drug delivery offers several applications for drugs having poor bioavailability
because of the narrow absorption window in the upper part of the gastrointestinal tract. It
retains the dosage form at the site of absorption and thus enhances the bioavailability
3
Advantages of gastroretentive drug delivery system
1. It increases patient compliance by reducing dosing frequency
2. Buoyancy increases gastric residence time
3. Better therapeutic effect of short half-life drugs
4. Site specific drug delivery to stomach can be achieved
5. Gastric irritation can be avoided by designing sustained release.
6. No risk of dose dumping by making single unit floating unit such as microspheres
releases drug uniformly.
7. Delivery of drugs with narrow absorption window in the small intestine region.
8. Longer residence time in the stomach could be advantageous for local action in the
upper part of the small intestine, for example treatment of peptic ulcer disease.
9. Improved bio-availability is expected for drugs that are absorbed readily upon release
in the GI tract such as cyclosporine, ciprofloxacin, ranitidine, amoxicillin, captopril,etc.
10. Targeted therapy for local ailments in the upper GI tract
4
Disadvantages of gastroretentive drug delivery system
1. Floating systems has limitation, that they require high level of fluids in stomach for floating and working
efficiently. So more water intake is prescribed with such dosage form.
2. In supine posture (like sleeping), floating dosage form may swept away (if not of larger size) by contractile
waves. So patient should not take floating dosage form just before going to bed.
3. Drugs having stability problem in high acidic environment, having very low solubility in acidic
environment and drugs causing irritation to gastric mucosa cannot be incorporated into GRDDS.
4. Bio/mucoadhesives systems have problem of high turnover rate of mucus layer, thick mucus layer &
soluble mucus related limitations.
5. Swellable dosage form must be capable to swell fast before its exit from stomach and achieve size larger
than pylorus aperture. It must be capable to resist the housekeeper waves of Phase III of MMC.
6. Gastric retention is influenced by many factors such as gastric motility, pH and presence of food. These
factors are never constant and hence the buoyancy cannot be predicted.
7. The major challenge for a bio adhesive system is the high turnover rate of gastric mucus.
8. There is also possibility of esophageal binding with bio adhesive drug delivery systems.
9. Drugs which have stability and solubility problems in GIT are not suitable candidates for these types of
systems. 5
APPROACHES
• Floating Systems
• Gastroadhesive Systems
• High-density Systems
• Inflatable Gastrointestinal Systems
6
A) Floating systems
Floating
systems
Effervescent
system
Volatile liquid
containing system
Gas generating
system
Non-effervescent
system
Hydrodynamically
balanced system
Microporous
compartment
system
Alginate beads
Microballons
7
• Floating systems are low-density systems remain afloat above the gastric contents for
prolonged periods of time and provide continuous release of the drug.
I) Effervescent systems
Effervescent systems include use of gas generating agents, carbonates (e.g. Sodium
bicarbonate) and other organic acid (e.g. citric acid and tartaric acid) present in the
formulation to produce carbon dioxide (CO2) gas, thus reducing the density of system and
making it float on the gastric fluid
a) Volatile liquid containing systems- System consists of two chambers separated by an
impermeable, pressure-responsive, movable bladder. The first chamber contains the drug
and the second chamber contains the volatile liquid (e.g. ether, cyclopentane),liquid
gasifies at body temperature causes inflatation of the chamber in the stomach. The
device inflates, and the drug is continuously released from the reservoir into the gastric
fluid.
8
b) Gas generating system -CO2 can be generated in situ by the incorporation of
carbonates or bicarbonates, which react with acid- either the natural gastric acid or
coformulated as citric or tartaric acid.
II) Non effervescent systems
Noneffervescent systems incorporate a high level of one or more gel-forming, highly
swellable, cellulosic hydrocolloids , polysaccharides, or matrix forming polymers into
tablets or capsules. Upon coming into contact with gastric fluid, these gel formers,
polysaccharides and polymers hydrate and form a colloidal gel barrier that controls the
rate of fluid penetration into the device and consequent drug release.
9
a) Hydrodynamically balanced systems -In this system hydrophilic polymer is mixed
with drug and usually administered in a gelatin capsule. The capsules rapidly dissolve in
the gastric fluid, and hydration and swelling of the surface polymer produce a floating
mass. Drug release is controlled by the formation of hydrated boundary at the surface.
b) Microporous compartment system -Encapsulation of a drug reservoir inside a
microporous compartment with pores along its top and bottom walls. The peripheral walls
of the drug reservoir compartment are completely sealed to prevent any direct contact of
gastric surface. In the stomach, the floatation chamber contains trapped air causes the
delivery system to float over the gastric content. Gastric fluid enters through the aperture
dissolves the drug and carries the dissolved drug for continuous transport across the
intestine for absorption.
10
c) Alginate beads -. Spherical beads of freeze dried calcium alginate of approx
2.5 mm in diameter prepared by dropping sodium alginate solution into
aqueous solution of calcium chloride to form porous system, which can
maintain a floating force for over 12 hours. These floating beads gave a
prolonged residence time of more than 5.5 hours
d) Micro balloons or Hollow Microspheres -Micro balloons / hollow
microspheres loaded with drugs in their other polymer shelf were prepared by
simple solvent evaporation or solvent diffusion method to prolong the GRT
(gastric residence time)of the dosage form.. Buoyancy and drug release from
dosage form are dependent on quantity of polymers, the plasticizer polymer
ratio and the solvent used for formulation.
11
B) Gastroadhesive Systems
This approach involves the use of bio adhesive polymers, which can
adhere to the epithelial cell surface or mucin in the stomach. It increases
the GRT by increasing the intimacy and duration of contact between the
dosage form and the biological membrane Some of the most promising
excipients that have been used are polycarbophil, carbopol, lections,
chitosan andgliadin, etc.
12
• Binding of polymers to the mucin/epithelial surface can be divided into
three categories:
a. Hydration – mediated adhesion-Certain hydrophilic polymers have the
tendency to imbibe large amount of water and become sticky,
b. Bonding –mediated adhesion -The adhesion of polymers to a mucus
involves physical or mechanical or chemical bonding.
c. Receptor – mediated adhesion- The receptor mediated events serves as
a potential approach in bio/mucoadhesion, hence enhancing the gastric
retention of dosage forms.
13
C) High-density systems
These systems, which have a density of ~3 g/cm3, are retained in the rugae
of the stomach and are capable of withstanding its peristaltic movements.
Above a threshold density of 2.4–2.8 g/cm3, such systems can be retained
in the lower part of the stomach. Diluents such as barium sulphate, zinc
oxide, titanium dioxide, and iron powder may be used to manufacture such
high density formulations.
14
D) Inflatable Gastrointestinal Systems
• In these systems an inflatable chamber is incorporated, which contains liquid ether
that gasifies at body temperature to cause the chamber to inflate in the stomach.
• These systems are fabricated by loading the inflatable chamber with a drug reservoir,
which can be a drug impregnated polymeric matrix, encapsulated in a gelatin
capsule.
• After oral administration, the capsule dissolves to release the drug reservoir together
with the inflatable chamber. The inflatable chamber automatically inflates and retains
the drug reservoir compartment in the stomach. The drug continuously released from
the reservoir into the gastric fluid.
15
Application of gastroretentive drug delivery
system
• Enhanced bioavailability
• Sustained drug delivery
• Site specific drug delivery system
• Absorption enhancement
• Minimized adverse activity at the colon
• Reduced fluctuation of drug concentration
16
17

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Gastroretentive drug delivery System

  • 1. GASTRORETENTIVE DRUG DELIVERY SYSTEM Presented By: Pranali M. Palandurkar University department of pharmaceutical sciences R.T.M.N.U Nagpur
  • 3. INTRODUCTION • Oral sustained drug delivery system is complicated by limited gastric residence time. • Rapid gastrointestinal transit can prevent complete drug release in the absorption zone and reduce the efficacy of administered dose, since the majority of drugs are absorbed in stomach or the upper part of small intestine . • Gastro-retentive delivery is one of the site specific delivery for the delivery of drugs either at stomach or at intestine. It is obtained by retaining dosage form into stomach and drug is being released at controlled manner to specific site either in stomach, duodenum and intestine • Floating drug delivery offers several applications for drugs having poor bioavailability because of the narrow absorption window in the upper part of the gastrointestinal tract. It retains the dosage form at the site of absorption and thus enhances the bioavailability 3
  • 4. Advantages of gastroretentive drug delivery system 1. It increases patient compliance by reducing dosing frequency 2. Buoyancy increases gastric residence time 3. Better therapeutic effect of short half-life drugs 4. Site specific drug delivery to stomach can be achieved 5. Gastric irritation can be avoided by designing sustained release. 6. No risk of dose dumping by making single unit floating unit such as microspheres releases drug uniformly. 7. Delivery of drugs with narrow absorption window in the small intestine region. 8. Longer residence time in the stomach could be advantageous for local action in the upper part of the small intestine, for example treatment of peptic ulcer disease. 9. Improved bio-availability is expected for drugs that are absorbed readily upon release in the GI tract such as cyclosporine, ciprofloxacin, ranitidine, amoxicillin, captopril,etc. 10. Targeted therapy for local ailments in the upper GI tract 4
  • 5. Disadvantages of gastroretentive drug delivery system 1. Floating systems has limitation, that they require high level of fluids in stomach for floating and working efficiently. So more water intake is prescribed with such dosage form. 2. In supine posture (like sleeping), floating dosage form may swept away (if not of larger size) by contractile waves. So patient should not take floating dosage form just before going to bed. 3. Drugs having stability problem in high acidic environment, having very low solubility in acidic environment and drugs causing irritation to gastric mucosa cannot be incorporated into GRDDS. 4. Bio/mucoadhesives systems have problem of high turnover rate of mucus layer, thick mucus layer & soluble mucus related limitations. 5. Swellable dosage form must be capable to swell fast before its exit from stomach and achieve size larger than pylorus aperture. It must be capable to resist the housekeeper waves of Phase III of MMC. 6. Gastric retention is influenced by many factors such as gastric motility, pH and presence of food. These factors are never constant and hence the buoyancy cannot be predicted. 7. The major challenge for a bio adhesive system is the high turnover rate of gastric mucus. 8. There is also possibility of esophageal binding with bio adhesive drug delivery systems. 9. Drugs which have stability and solubility problems in GIT are not suitable candidates for these types of systems. 5
  • 6. APPROACHES • Floating Systems • Gastroadhesive Systems • High-density Systems • Inflatable Gastrointestinal Systems 6
  • 7. A) Floating systems Floating systems Effervescent system Volatile liquid containing system Gas generating system Non-effervescent system Hydrodynamically balanced system Microporous compartment system Alginate beads Microballons 7
  • 8. • Floating systems are low-density systems remain afloat above the gastric contents for prolonged periods of time and provide continuous release of the drug. I) Effervescent systems Effervescent systems include use of gas generating agents, carbonates (e.g. Sodium bicarbonate) and other organic acid (e.g. citric acid and tartaric acid) present in the formulation to produce carbon dioxide (CO2) gas, thus reducing the density of system and making it float on the gastric fluid a) Volatile liquid containing systems- System consists of two chambers separated by an impermeable, pressure-responsive, movable bladder. The first chamber contains the drug and the second chamber contains the volatile liquid (e.g. ether, cyclopentane),liquid gasifies at body temperature causes inflatation of the chamber in the stomach. The device inflates, and the drug is continuously released from the reservoir into the gastric fluid. 8
  • 9. b) Gas generating system -CO2 can be generated in situ by the incorporation of carbonates or bicarbonates, which react with acid- either the natural gastric acid or coformulated as citric or tartaric acid. II) Non effervescent systems Noneffervescent systems incorporate a high level of one or more gel-forming, highly swellable, cellulosic hydrocolloids , polysaccharides, or matrix forming polymers into tablets or capsules. Upon coming into contact with gastric fluid, these gel formers, polysaccharides and polymers hydrate and form a colloidal gel barrier that controls the rate of fluid penetration into the device and consequent drug release. 9
  • 10. a) Hydrodynamically balanced systems -In this system hydrophilic polymer is mixed with drug and usually administered in a gelatin capsule. The capsules rapidly dissolve in the gastric fluid, and hydration and swelling of the surface polymer produce a floating mass. Drug release is controlled by the formation of hydrated boundary at the surface. b) Microporous compartment system -Encapsulation of a drug reservoir inside a microporous compartment with pores along its top and bottom walls. The peripheral walls of the drug reservoir compartment are completely sealed to prevent any direct contact of gastric surface. In the stomach, the floatation chamber contains trapped air causes the delivery system to float over the gastric content. Gastric fluid enters through the aperture dissolves the drug and carries the dissolved drug for continuous transport across the intestine for absorption. 10
  • 11. c) Alginate beads -. Spherical beads of freeze dried calcium alginate of approx 2.5 mm in diameter prepared by dropping sodium alginate solution into aqueous solution of calcium chloride to form porous system, which can maintain a floating force for over 12 hours. These floating beads gave a prolonged residence time of more than 5.5 hours d) Micro balloons or Hollow Microspheres -Micro balloons / hollow microspheres loaded with drugs in their other polymer shelf were prepared by simple solvent evaporation or solvent diffusion method to prolong the GRT (gastric residence time)of the dosage form.. Buoyancy and drug release from dosage form are dependent on quantity of polymers, the plasticizer polymer ratio and the solvent used for formulation. 11
  • 12. B) Gastroadhesive Systems This approach involves the use of bio adhesive polymers, which can adhere to the epithelial cell surface or mucin in the stomach. It increases the GRT by increasing the intimacy and duration of contact between the dosage form and the biological membrane Some of the most promising excipients that have been used are polycarbophil, carbopol, lections, chitosan andgliadin, etc. 12
  • 13. • Binding of polymers to the mucin/epithelial surface can be divided into three categories: a. Hydration – mediated adhesion-Certain hydrophilic polymers have the tendency to imbibe large amount of water and become sticky, b. Bonding –mediated adhesion -The adhesion of polymers to a mucus involves physical or mechanical or chemical bonding. c. Receptor – mediated adhesion- The receptor mediated events serves as a potential approach in bio/mucoadhesion, hence enhancing the gastric retention of dosage forms. 13
  • 14. C) High-density systems These systems, which have a density of ~3 g/cm3, are retained in the rugae of the stomach and are capable of withstanding its peristaltic movements. Above a threshold density of 2.4–2.8 g/cm3, such systems can be retained in the lower part of the stomach. Diluents such as barium sulphate, zinc oxide, titanium dioxide, and iron powder may be used to manufacture such high density formulations. 14
  • 15. D) Inflatable Gastrointestinal Systems • In these systems an inflatable chamber is incorporated, which contains liquid ether that gasifies at body temperature to cause the chamber to inflate in the stomach. • These systems are fabricated by loading the inflatable chamber with a drug reservoir, which can be a drug impregnated polymeric matrix, encapsulated in a gelatin capsule. • After oral administration, the capsule dissolves to release the drug reservoir together with the inflatable chamber. The inflatable chamber automatically inflates and retains the drug reservoir compartment in the stomach. The drug continuously released from the reservoir into the gastric fluid. 15
  • 16. Application of gastroretentive drug delivery system • Enhanced bioavailability • Sustained drug delivery • Site specific drug delivery system • Absorption enhancement • Minimized adverse activity at the colon • Reduced fluctuation of drug concentration 16
  • 17. 17