This document discusses mucoadhesive drug delivery systems. It begins by defining mucoadhesive drug delivery as a system that utilizes the bioadhesive properties of water soluble polymers to target and maintain a drug at a specific site in the body for an extended period. It then discusses various types of mucoadhesive systems including buccal, oral, nasal, ocular, and rectal. The document outlines the mechanism of mucoadhesion and factors affecting it. It provides examples of mucoadhesive dosage forms and their advantages and disadvantages. Evaluation tests for these systems are also mentioned. The objective of developing mucoadhesive forms for prolonged drug absorption using various mucoadhesive polymers is stated.
FORMULATION AND EVALUATION OF OCUSERTS OF CIPROFLOXACIN HClMohammad Adil
Conventional ocular drug delivery system i.e., eye drops, ointments, gels etc., had become less popular pertaining to their disadvantages like evaporation by tears, pre-corneal loss, drug metabolism, drug-protein interaction, drainage, sticking of eye lids, induced lacrimation, poor patient compliance, systemic side effect and blurred vision etc. That’s why fundamentals of controlled release by means of ocular inserts were utilized to increase problem pre-corneal drug residence time.
This project title “Formulation and Evaluation of Ocuserts of Ciprofloxacin HCl” revealed following results:
Compatibility study using FTIR was performed to check the compatibility of drug with various excipient. Characteristics peaks obtained with pure drug were compared with that produced with different excipients that confirmed the compatibility of drug with excipients.
Ocusert of Ciprofloxacin HCl was prepared using different material i.e., PVP K-30, PVA, PEG 400 and glycerin.
Prepared ocuserts were evaluated for various parameters viz., percentage moisture loss, percentage moisture absorbs, thickness, weight variation, drug content and In-vitro diffusion.
The percentage (%) moisture absorption and loss of ocular insert were found to be 26% and 27% respectively.
The thickness of ocular insert was found to be uniformed and its mean while measuring at different points was found to be 0.124mm.
The weight of ocular inserts was found to be in the range of 12.2 - 12.6mg which indicated decent distribution of the drug, polymer and plasticizer.
The drug content of ocular insert was found to be 99.89%.
Percentage drug release from Ciprofloxacin HCl Ocusert was found to be 41.969% in 8 hr.
It was concluded that prepared Ocusert of Ciprofloxacin HCl could be a better alternative to conventional ocular formulations that retained on ocular surface for longer duration and released drug in controlled manner.
UNIT V
Mucoadhesive Delivery Systems:
Mechanism of bioadhesion, mucoadhesive materials, formulation and evaluation of Buccal and Nasal drug delivery systems.
FORMULATION AND EVALUATION OF OCUSERTS OF CIPROFLOXACIN HClMohammad Adil
Conventional ocular drug delivery system i.e., eye drops, ointments, gels etc., had become less popular pertaining to their disadvantages like evaporation by tears, pre-corneal loss, drug metabolism, drug-protein interaction, drainage, sticking of eye lids, induced lacrimation, poor patient compliance, systemic side effect and blurred vision etc. That’s why fundamentals of controlled release by means of ocular inserts were utilized to increase problem pre-corneal drug residence time.
This project title “Formulation and Evaluation of Ocuserts of Ciprofloxacin HCl” revealed following results:
Compatibility study using FTIR was performed to check the compatibility of drug with various excipient. Characteristics peaks obtained with pure drug were compared with that produced with different excipients that confirmed the compatibility of drug with excipients.
Ocusert of Ciprofloxacin HCl was prepared using different material i.e., PVP K-30, PVA, PEG 400 and glycerin.
Prepared ocuserts were evaluated for various parameters viz., percentage moisture loss, percentage moisture absorbs, thickness, weight variation, drug content and In-vitro diffusion.
The percentage (%) moisture absorption and loss of ocular insert were found to be 26% and 27% respectively.
The thickness of ocular insert was found to be uniformed and its mean while measuring at different points was found to be 0.124mm.
The weight of ocular inserts was found to be in the range of 12.2 - 12.6mg which indicated decent distribution of the drug, polymer and plasticizer.
The drug content of ocular insert was found to be 99.89%.
Percentage drug release from Ciprofloxacin HCl Ocusert was found to be 41.969% in 8 hr.
It was concluded that prepared Ocusert of Ciprofloxacin HCl could be a better alternative to conventional ocular formulations that retained on ocular surface for longer duration and released drug in controlled manner.
UNIT V
Mucoadhesive Delivery Systems:
Mechanism of bioadhesion, mucoadhesive materials, formulation and evaluation of Buccal and Nasal drug delivery systems.
Mucoadhesive drug delivery system interact with the mucus layer covering the mucosal epithelial surface, & mucin molecules & increase the residence time of the dosage form at the site of the absorption.
Mucoadhesive drug delivery system is a part of controlled delivery system.
Since the early 1980,the concept of Mucoadhesion has gained considerable interest in pharmaceutical technology.
combine mucoadhesive with enzyme inhibitory & penetration enhancer properties & improve the patient complaince.
MDDS have been devloped for buccal ,nasal,rectal &vaginal routes for both systemic & local effects.
Hydrophilic high mol. wt. such as peptides that cannot be administered & poor absorption ,then MDDS is best choice.
Mucoadhesiveinner layers called mucosa inner epithelial cell lining is covered with viscoelasticfluid
Composed of water and mucin.
Thickness varies from 40 μm to 300 μm
General composition of mucus
Water…………………………………..95%
Glycoproteinsand lipids……………..0.5-5%
Mineral salts……………………………1%
Free proteins…………………………..0.5-1%
The mechanism responsible in the formation of mucoadhesive bond
Step 1 : Wetting and swelling of the polymer(contact stage)
Step 2 : Interpenetration between the polymer chains and the mucosal membrane
Step 3 : Formation of bonds between the entangled chains (both known as consolidation stage)
Electronic theory
Wetting theory
Adsorption theory
Diffusion theory
Fracture theory
Advantages over other controlled oral controlled release systems by virtue of prolongation of residence of drug in GIT.
Targeting & localization of the dosage form at a specific site
-Painless administration.
-Low enzymatic activity & avoid of first pass metabolism
If MDDS are adhere too tightlgy because it is undesirable to exert too much force to remove the formulation after use,otherwise the mucosa could be injured.
-Some patient suffers unpleasent feeling.
-Unfortunately ,the lack of standardized techniques often leads to unclear results.
-costly drug delivery system
Intrauterine drug delivery system - nddsJafarali Masi
novel drug delivery system(NDDS) b.pharma semester 7,
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages, development of intra uterine devices (IUDs) and applications
This presentation includes introduction, physiology of GIT, factors affecting GRDDS, Advantages and disadvantages, approaches to GRDDS and their mechanism, some of the marketed products using GRDDS mechanism.
Osmotic drug delivery uses the osmotic pressure of drug or other solutes (osmogens or osmagents) for controlled delivery of drugs. Osmotic drug delivery has come a long way since Australian physiologists Rose and Nelson developed an implantable pump in 1955.
Gastro retentive drug delivery system (GRDDS)Shweta Nehate
Oral route is the most acceptable route for drug administration. Apart from conventional dosage forms several other forms were developed in order to enhance the drug delivery for prolonged time period and for delivering drug to a particular target site. Gastro-retentive drug delivery system (GRDDS) has gainned immense popularity in the field of oral drug delivery recently. it is a widely employed approach to retain the dosage form in the stomach for an extended period of time and release the drug slowly that can address many challenges associated with conventional oral delivery, including poor bioavailability. different innovative approaches are being applied to fabricate GRDDS. Gastroretentive drug delivery is an approach to prolong gastric residence time, there by targeting site-specific drugs release in the upper gastrointestinal tract (GIT) for local or systemic effects. It is obtained by retaining dosage form into stomach and by releasing the in controlled manner.
. Recent Advances in Mucoadhesive Buccal Drug Delivery Systems and Its Marketed Scope and
Opportunities
K.P.Sampath Kumar ,DebjitBhowmik .AmitsankarDutta, Shravan Paswan, Lokesh Deb
Critical Review in Pharmaceutical Sciences 2012, 1(1):83-98.
Mucoadhesive drug delivery system interact with the mucus layer covering the mucosal epithelial surface, & mucin molecules & increase the residence time of the dosage form at the site of the absorption.
Mucoadhesive drug delivery system is a part of controlled delivery system.
Since the early 1980,the concept of Mucoadhesion has gained considerable interest in pharmaceutical technology.
combine mucoadhesive with enzyme inhibitory & penetration enhancer properties & improve the patient complaince.
MDDS have been devloped for buccal ,nasal,rectal &vaginal routes for both systemic & local effects.
Hydrophilic high mol. wt. such as peptides that cannot be administered & poor absorption ,then MDDS is best choice.
Mucoadhesiveinner layers called mucosa inner epithelial cell lining is covered with viscoelasticfluid
Composed of water and mucin.
Thickness varies from 40 μm to 300 μm
General composition of mucus
Water…………………………………..95%
Glycoproteinsand lipids……………..0.5-5%
Mineral salts……………………………1%
Free proteins…………………………..0.5-1%
The mechanism responsible in the formation of mucoadhesive bond
Step 1 : Wetting and swelling of the polymer(contact stage)
Step 2 : Interpenetration between the polymer chains and the mucosal membrane
Step 3 : Formation of bonds between the entangled chains (both known as consolidation stage)
Electronic theory
Wetting theory
Adsorption theory
Diffusion theory
Fracture theory
Advantages over other controlled oral controlled release systems by virtue of prolongation of residence of drug in GIT.
Targeting & localization of the dosage form at a specific site
-Painless administration.
-Low enzymatic activity & avoid of first pass metabolism
If MDDS are adhere too tightlgy because it is undesirable to exert too much force to remove the formulation after use,otherwise the mucosa could be injured.
-Some patient suffers unpleasent feeling.
-Unfortunately ,the lack of standardized techniques often leads to unclear results.
-costly drug delivery system
Intrauterine drug delivery system - nddsJafarali Masi
novel drug delivery system(NDDS) b.pharma semester 7,
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages, development of intra uterine devices (IUDs) and applications
This presentation includes introduction, physiology of GIT, factors affecting GRDDS, Advantages and disadvantages, approaches to GRDDS and their mechanism, some of the marketed products using GRDDS mechanism.
Osmotic drug delivery uses the osmotic pressure of drug or other solutes (osmogens or osmagents) for controlled delivery of drugs. Osmotic drug delivery has come a long way since Australian physiologists Rose and Nelson developed an implantable pump in 1955.
Gastro retentive drug delivery system (GRDDS)Shweta Nehate
Oral route is the most acceptable route for drug administration. Apart from conventional dosage forms several other forms were developed in order to enhance the drug delivery for prolonged time period and for delivering drug to a particular target site. Gastro-retentive drug delivery system (GRDDS) has gainned immense popularity in the field of oral drug delivery recently. it is a widely employed approach to retain the dosage form in the stomach for an extended period of time and release the drug slowly that can address many challenges associated with conventional oral delivery, including poor bioavailability. different innovative approaches are being applied to fabricate GRDDS. Gastroretentive drug delivery is an approach to prolong gastric residence time, there by targeting site-specific drugs release in the upper gastrointestinal tract (GIT) for local or systemic effects. It is obtained by retaining dosage form into stomach and by releasing the in controlled manner.
. Recent Advances in Mucoadhesive Buccal Drug Delivery Systems and Its Marketed Scope and
Opportunities
K.P.Sampath Kumar ,DebjitBhowmik .AmitsankarDutta, Shravan Paswan, Lokesh Deb
Critical Review in Pharmaceutical Sciences 2012, 1(1):83-98.
Design, optimization and in vitro evaluation of gastroretentive hollow micros...SURYAKANTVERMA2
To modify the GIT time is one of the main challenge in the development of oral controlled drug delivery system.
Gastric emptying of pharmaceutical dosage form is highly variable and dependent on the dosage form and the fed/fasted state of the stomach.
Normal gastric residence time usually ranges between 5 minutes to 2 hours.
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2. INTRODUCTION
Novel drug delivery systems (NDDS)
are the system where the man
searches for new methods of entry of
drugs in to the body in order to show
its activity in the body .
The new drug delivery systems that
have been developed and developing
are the mucoadhesive drug delivery
systems , drug patches, transdermal
patches etc.
3. DEFINITION
Mucoadhesive drug delivery system may
be defined as a drug delivery system
which utilize property of bioadhesion of
certain water soluble polymers which
become adhesive on hydration and hence
can be used for targeting a drug to a
particular region of the body for extended
periods of time.
4. TYPES OF MUCOADHESIVE DRUG DELIVERY
SYSTEM
ORAL
BUCCAL
MUCOADHESIVE RECTAL
VAGINAL
OCULAR
NASAL
5. MECHANISM OF MUCOADHESIVE
COMPOSITION OF
MUCOUS
Water > 95%
Glycoprotein of high
molecular weight
Mineral salts – 1%
Free salts – 0.5-1%
6. FACTORS AFFECTING MUCOADHESIVE
1. Polymer related factors
i) Molecular weight :
ii)Concentration of active polymer
iii)Flexibility of polymer chains
2.Environment related factors :
i)pH of polymer - substrate interface
ii) Applied strength
iii) Initial contact time
iv)Swelling
3. Physiological factors:
i)Disease state
7. ADVANTAGES
First pass elimination associated with oral administration
, so increase the bioavaibility and therapeutic activity.
Both lipophilic and hydrophilic drug can be permeated.
These dosage forms are readily localized in the region
applied to improve and enhance the bioavailability of
drugs
Mucoadhesive dosage forms also prolong the residence
time of the dosage form at the site of application and
absorption to permit once or twice a day dosing.
8. DISADVANTAGES
Oral ingestions results in more exposure of a drug
to the GI tract. One of the side effects of many
antibiotics is the destruction of normal GI flora
resulting in diarrhea and overgrowth with
dangerous organisms such as C. difficile.
The absorption of mucoadhesive drugs is adversely
affected by the presence of food. Tetracycline's, in
particular, complicates the administration of this
class of antibiotics via the oral route.
9. MUCOADHESIVE DOSAGE FORMS
Mucoadhesive Buccal Films:
Mucoadhesive buccal films are most commonly prepared by the
solvent casting technique in which various substrates including
mercury, Teflon, glass and aluminium are used for film formation.
Among these substrates, mercury was found to give best results.
Mucoadhesive microspheres:
Mucoadhesive microspheres have advantages of efficient
absorption and enhanced bioavailability of drugs, a much more
intimate contact with the mucus layer, and specific targeting of
drugs to the absorption site.
Mucoadhesive microparticles:
Mucoadhesive microparticles is an improved drug delivery system
which are believed to bind to the mucus layer coating the stomach
and other regions of the GIT. These mucoadhesive microparticles
bind to the mucus layer leading either to slow release into the GIT
or direct delivery to the gastrointestinal mucosa.
10. Mucoadhesive microcapsules:
Mucoadhesive microcapsules are a type of controlled-release dosage form.
They offer numerous benefits including reducing stress resulting from
restraint, handling, and dosing and avoiding expensive or difficult drug
administration procedures. They can be used for vaginal administration to
treat vaginal infections and to increase patient convenience.
Mucoadhesive tablets:
Mucoadhesive tablets have been developed to increase the retention of drug in
GIT and/or to keep a sustained release of drug towards the medium from
where it is constantly removed. Thus, treatment of many diseases is done.
Mucoadhesive patches:
These mucoadhesive formulations offer many advantages in comparison to
traditional treatments and can be proposed as a new therapeutic tool against
dental and buccal diseases and disturbances.
11. EVALUATION TEST
1)Weight variation
2)Friability
3)Hardness
4)Content uniformity
5) Drug release study of Mucoadhesive tablets
6) Swelling index
7)Water sorption studies
8)Mucoadhesive strength
12. AIM AND OBJECTIVE
DRUG CATEGORY CLASS HALF-LIFE
The objective of the
study mainly is to
Diltiazem Anti-anginal, Calcium 3-4.5
develop, characterize channel hours
Anti-
and evaluate arrythmiatic blocking
agent
mucoadhesive
Atenolol Anti- B- 6-7 hours
dosage forms Hypertensive, adrenergic
employing various Anti-anginal blocking
agent
mucoadhesive
Nifedipine Anti- Calcium 2-5 hours
polymers for Hypertensive, channel
prolonged absorption. Anti-anginal blocking
agent
The mentioned Captopril Anti- Acetylcholin 2-5 hours
Hypertensive e inhibitor
drugs are most
Anti angial
commonly used in
the preparation of
mucoadhesive drug
delivery systems.
13. Buccal drug delivery system
Drug delivery according to membranes of oral cavity:
A. Sublingual delivery: The membrane of tongue and
the floor of the mouth.
Administration of drug via sublingual mucosa to
systemic circulation.
B. Buccal delivery: The lining of
cheek.
Administration of drug via buccal mucosa
to the systemic circulation.
Local delivery : For the treatment of condition of the oral
cavity. Eg. Apthous ulcer, fungal condition
14. ADVANTAGES
1. Bypasses the hepatic first pass metabolism and greater
bioavailability.
2. Delivery device can be made unidirectional: only oral mucosal
absorption.
3. Buccal mucosa is less prone to damage or irritation than oral
mucosa.
4. Extent of perfusion is more , therefore quick and effective.
5. Nausea and vomiting are greatly avoided.
Since the formulation is light:
•Less transport cost
•Economy of raw material
•cheap
15. DISADVANTAGES
1. Relatively smaller area of absorption
2. The thickness of delivery system should be limited to
a few millimeter in order to avoid inconveniences for
patient.
3. Part of drug may be dissolve in saliva and may be
swallowed.
4. Drugs which irritate oral mucosa or have bitter taste
cause allergic reaction , discoloration teeth cannot be
formulated.
5. If formulation contains antimicrobial agents, affect the
natural microbial flora of mouth.