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Presented by Under The Guidance
Khan Ramiz V Prof. S. Talele
M. Pharm (1st year)
Dept. of Pharmaceutics
SIPS 1
INTRODUCTION
 BUCCAL DRUG DELIVERY SYSTEM (NDDS)
It is defined as the drug deliver through the buccal
mucosa of oral cavity is called as BDDS. The buccal
mucosa lines the inner cheek
In biological term, the product is places between
upper gingiva (gums) & cheek to treat local systemic
conditions.
2
Advantages
 Avoid first pass metabolism
 Avoid acid/Enzyme metabolism
 Permeation is faster with respect to skin & TDDS
 Large surface area with respect to sub-lingual mucosa
 Good patient compliance with respect to parental
 Easy administration & removal in case of toxicity
 For unconscious or conatuse patients
3
Disadvantages
 Drug with bitter taste or irritant to mucosa or having
noxious smell
 Not for children
 Eating & drinking difficulty
 Salivary erosion & it may enter GIT & choke esophagus
 Less surface area than skin
 Drug unstable at Buccal pH (6.5 to 7)
4
5
Environment of Buccal Mucosa
 The cells of the oral epithelia are surrounded by an
intercellular ground substance, mucus.
 The oral cavity is marked by the presence of saliva
produced by the salivary glands.
 Mucus which is secreted by the major and minor
salivary glands as part of saliva
6
Mechanism
The bioadhesion mainly depends upon nature of
bioadhesive polymer
First stage involves an intimate contact between a
bioadhesive and a membrane
Second stage Involves penetration of the bioadhesive
into tissue
Drug release
Bypasses first pass metabolism
Enters systemic circulation
7
8
IDEAL CHARACTERISTICS OF BDDS
 Molecular size 74-100 Daltons.
 Molecular weight 200-500g/mol
 Drug should be hydrophilic/hydrophobic in nature
 Drug should be stable in buccal pH (6.4-7.2)
 Drug should be odourless
 Drug which are absorbed only by passive diffusion
9
Formulation of BDDC
The basic components of buccal drug delivery system
 Drug substance
 Permeation enhancers
 Bioadhesive polymers
 Backing membrane
10
Drug substance
 Dose of the drug should be small
 Half life between 2-8 hours
 Exhibit first pass metabolism
 Absorption should be passive when given orally
Ex:
1. Nicotine
2. Nifedipine
3. Propranolol
4. Diclofenac sodium
11
Permeation enhacers
 The substance added to pharmaceutical formulation in
order to increase the membrane permeation rate or
absorption rate of co-administered drug.
Ex:
 Sodium lauryl sulfate
 Bile salt :sodium glycodeoxycholate, sodium
glycocholate
12
Bioadhesive Polymers
 Polymers used in matrix devices in which the drug in
embedded in the polymer matrix, which controls the
duration of release of drugs.
IDEAL CHARACTERISTICS
Should be inert and compatible with the environment
Non-toxic absorbable from the Mucous layer.
Site specificity
Not decompose on storage
Easily available in the market
Economical
13
14
Backing membrane
 Ability to attachment of adhesive device to mucus
membrane
 Inert in nature and impermeable to the drug
 Such impermeable membrane prevent drug loss and
good patient compliances
Ex: Carbopol, magnesium stearate, polycarbopol
15
16
17
Types of buccal formulation
 Buccal Tablets
 Buccal Patches and Films
 Buccal Semisolid (Ointment and gels)
 Buccal Powder
18
Uses of Buccal delivery
 The oral cavity can be used for local and systemic
therapy.
 Local therapy would be the treatment of oral infections,
dental caries, mouth ulcers, stomatitis , gingivitis etc.
 The buccal route is of particular interest with regard to
the systemic delivery of small molecules that are
subjected to first pass metabolism
19
Evaluation of Buccal patch
 Surface pH : buccal patches are left to swell for 2 hrs on the
surface of an agar plate. The surface pH is measured by
means of a pH paper placed on the surface o the swollen
patch.
 Thickness measurement : The thickness of each film is
measured at five different location (center and four corners)
using an electronic digital micrometer.
 Swelling study :
 Folding endurance : The folding endurance of patches is
determined by repeatedly folding 1 patch at the times without
breaking
20
Thermal analysis study : Thermal analysis study is
performed using differential scanning calorimeter (DSC)
Morphological characterization :
Morphological characters are studied by using
scanning electron microscope (SEM)
21
Conclusion
The Buccal mucosa offers several advantages for
controlled drug delivery for extended periods of time.
The mucosa is well supplied with both vascular and
lymphatic drainage and first pass metabolism in the
liver and pre-systemic elimination in the
gastrointestinal track avoided.
22
THANK YOU
23

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Novel drug delivery system

  • 1. Presented by Under The Guidance Khan Ramiz V Prof. S. Talele M. Pharm (1st year) Dept. of Pharmaceutics SIPS 1
  • 2. INTRODUCTION  BUCCAL DRUG DELIVERY SYSTEM (NDDS) It is defined as the drug deliver through the buccal mucosa of oral cavity is called as BDDS. The buccal mucosa lines the inner cheek In biological term, the product is places between upper gingiva (gums) & cheek to treat local systemic conditions. 2
  • 3. Advantages  Avoid first pass metabolism  Avoid acid/Enzyme metabolism  Permeation is faster with respect to skin & TDDS  Large surface area with respect to sub-lingual mucosa  Good patient compliance with respect to parental  Easy administration & removal in case of toxicity  For unconscious or conatuse patients 3
  • 4. Disadvantages  Drug with bitter taste or irritant to mucosa or having noxious smell  Not for children  Eating & drinking difficulty  Salivary erosion & it may enter GIT & choke esophagus  Less surface area than skin  Drug unstable at Buccal pH (6.5 to 7) 4
  • 5. 5
  • 6. Environment of Buccal Mucosa  The cells of the oral epithelia are surrounded by an intercellular ground substance, mucus.  The oral cavity is marked by the presence of saliva produced by the salivary glands.  Mucus which is secreted by the major and minor salivary glands as part of saliva 6
  • 7. Mechanism The bioadhesion mainly depends upon nature of bioadhesive polymer First stage involves an intimate contact between a bioadhesive and a membrane Second stage Involves penetration of the bioadhesive into tissue Drug release Bypasses first pass metabolism Enters systemic circulation 7
  • 8. 8
  • 9. IDEAL CHARACTERISTICS OF BDDS  Molecular size 74-100 Daltons.  Molecular weight 200-500g/mol  Drug should be hydrophilic/hydrophobic in nature  Drug should be stable in buccal pH (6.4-7.2)  Drug should be odourless  Drug which are absorbed only by passive diffusion 9
  • 10. Formulation of BDDC The basic components of buccal drug delivery system  Drug substance  Permeation enhancers  Bioadhesive polymers  Backing membrane 10
  • 11. Drug substance  Dose of the drug should be small  Half life between 2-8 hours  Exhibit first pass metabolism  Absorption should be passive when given orally Ex: 1. Nicotine 2. Nifedipine 3. Propranolol 4. Diclofenac sodium 11
  • 12. Permeation enhacers  The substance added to pharmaceutical formulation in order to increase the membrane permeation rate or absorption rate of co-administered drug. Ex:  Sodium lauryl sulfate  Bile salt :sodium glycodeoxycholate, sodium glycocholate 12
  • 13. Bioadhesive Polymers  Polymers used in matrix devices in which the drug in embedded in the polymer matrix, which controls the duration of release of drugs. IDEAL CHARACTERISTICS Should be inert and compatible with the environment Non-toxic absorbable from the Mucous layer. Site specificity Not decompose on storage Easily available in the market Economical 13
  • 14. 14
  • 15. Backing membrane  Ability to attachment of adhesive device to mucus membrane  Inert in nature and impermeable to the drug  Such impermeable membrane prevent drug loss and good patient compliances Ex: Carbopol, magnesium stearate, polycarbopol 15
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  • 18. Types of buccal formulation  Buccal Tablets  Buccal Patches and Films  Buccal Semisolid (Ointment and gels)  Buccal Powder 18
  • 19. Uses of Buccal delivery  The oral cavity can be used for local and systemic therapy.  Local therapy would be the treatment of oral infections, dental caries, mouth ulcers, stomatitis , gingivitis etc.  The buccal route is of particular interest with regard to the systemic delivery of small molecules that are subjected to first pass metabolism 19
  • 20. Evaluation of Buccal patch  Surface pH : buccal patches are left to swell for 2 hrs on the surface of an agar plate. The surface pH is measured by means of a pH paper placed on the surface o the swollen patch.  Thickness measurement : The thickness of each film is measured at five different location (center and four corners) using an electronic digital micrometer.  Swelling study :  Folding endurance : The folding endurance of patches is determined by repeatedly folding 1 patch at the times without breaking 20
  • 21. Thermal analysis study : Thermal analysis study is performed using differential scanning calorimeter (DSC) Morphological characterization : Morphological characters are studied by using scanning electron microscope (SEM) 21
  • 22. Conclusion The Buccal mucosa offers several advantages for controlled drug delivery for extended periods of time. The mucosa is well supplied with both vascular and lymphatic drainage and first pass metabolism in the liver and pre-systemic elimination in the gastrointestinal track avoided. 22