Route of administration of biotech products
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ROUTES OF ADMINISTRATION OF BIOTECH PRODUCTS:
PARENTERAL ROUTE CONSIDERING LEPTOSOMES
AND MICROSPHERES
BY:
Pharmacist MD. ALIUL ISLAM TANOY
GUIDED BY: Mohammad Shahriar(Assistant professor
of University of Asia Pacific)
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CONTENTS:
Routes of drug administration Definition of Parenteral Route Types of Parenteral Route Advantages and Disadvantages of Parenteral
Route Comparison of other route Biotech example of Parenteral Route Liposome & mechanism of drug delivery Application of Liposomes Microspheres & mechanism of drug delivery Application of Microspheres
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ROUTE OF ADMINISTRATION
A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body.
The pharmacokinetic properties, such as absorption, distribution, metabolism, and excretion, of a drug are critically influenced by the route of administration.
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PARENTERAL ROUTE:
The term “Parenteral” comes from two Greek words-‘ Para’ (outside) & ‘Enteron’ (intestine), meaning outside the intestine.
Parenteral route of administration means the medicine is generally directly administered by injection such as SC, IV, IM, IA, IT, or IC or through transdermal patches, which isn't administered with an injection but is still considered a parenteral route.
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TYPES OF PARENTERAL ROUTES
Intravenous also popularly known as I.V. which is given directly into a vein with injection.
Intra-arterial is given into an artery through injection, e.g. vasodilator drugs such as Sodium Nitroproside, Methyl Dopa etc.
Intra-muscular injection given to the muscular part of the body.
Intrathecal: Drug is direcly administered in to the spinal cord
Intraosseous infusion: Into the bone marrow
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ADVANTAGES OF PARENTERAL ADMINISTRATION:
Rapid action of drug. Can be employed in unconscious/ uncooperative
patients. Drugs, which are not absorbed in small intestine
or irritate the stomach can be administered by this route.
Drugs, which are modified by alimentary juices and liver can be given by this route.
can deliver drugs in large amounts, will have 100 percent bioavailability.
Does not have 1st pass metabolism. Polor drug can be given as they are absorbed, ( eg.- Streptomycin)
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DISADVANTAGE OF PARENTERAL ADMINISTRATION
Less safe, more expensive. Inconvenient (painful) for the patient. Self medication is difficult. Chances of local injury at the site of injection. It is difficult to reverse its physiological effect
.
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COMPARISON:Parenteral route Enteral route
1. The term “Parenteral” comes from two Greek words-‘ Para’ (outside) & ‘Enteron’ (intestine), meaning outside the intestine.
1. The term’ Enteral’ comes from one Greed words- ‘Enteros’ (intestine), meaning the intestine.
2. It’s mechanism of drug absorption is for most drugs is passive transfer (eg.- ‘Levodoa’ follows carrier mediated transport).
2. It’s mechanism of drug absorption is for most drugs is active transfer.
3. Drug can be directly enters systemic circulation.
3. Drug can’t directly enters systemic circulation
4. Does not have 1st pass metabolism.
4. Does have 1st pass metabolism.
5. Onset of action is faster. 5. Onset of action is slower.
6. Drug can be given unconscious & uncooperative patients.
6. Drug can’t be given unconscious & uncooperative patients.
7. Polor drug can be given as they are absorbed ( eg.- Streptomycin)
7. Polor drug can’t be given as they are absorbed ( eg.- Streptomycin)
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Manipulation of living organisms or their components to produce useful commercial products such as, new bacterial strains, or novel pharmaceuticals.
Therapeutic agents produced by biotechnological processes such as recombinant DNA technology, fermentation, tissue, cell culture technology and genetic engineering.
BIOTECHNOLOGY:
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BIOTECH EXAMPLES OF PARENTERAL ROUTES OF DRUGS:
Name Type Molecular target
Condition
Insulin Systemic Factor
Glucose metabolism
Diabetes
G-CSF Systemic Factor
Neutrophils Neutropenia
Erythropoietin Systemic Factor
Erythropoiesis Renal failure
Omalizumab Humanized monoclonal antibody
IgE Asthma
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Biocompatibility "Refers to the ability of a biomaterial to perform its desired function with respect to a medical therapy, without eliciting any undesirable local or systemic effects in the recipient or beneficiary of that therapy, but generating the most appropriate beneficial cellular or tissue response in that specific situation, and optimizing the clinically relevant performance of that therapy"
BIOCOMPATIBILTY OF PARENTERAL DOSAGE FORMS:
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BIOAVAILABILITY AND PARENTERAL DOSAGES FORMS VS ORAL DOSAGE FORMS :
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LIPOSOME
A liposome is a tiny bubble (vesicle), made out of the same material as a cell membrane. Liposomes can be filled with drugs, and used to deliver drugs for cancer and other diseases.
Membranes are usually made of phospholipids, which are molecules that have a head group and a tail group.
The head is attracted to water, and the tail, which is made of a long hydrocarbon chain, is repelled by water.
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LIPOSOMES CONTT…
When membrane phospholipids are disrupted, they can reassemble themselves into tiny spheres, smaller than a normal cell, either as bilayers or monolayers. The bilayer structures are liposomes. The monolayer structures are called micelles.
The name liposome is derived from two Greek words: 'Lipos' meaning fat and 'Soma' meaning body.
Liposomes were first described by British haematologist Dr Alec D Bangham FRS in 1961 (published 1964), at the Babraham Institute, in Cambridge.
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LIPOSOMES CONTT… They were discovered when Bangham and R.
W. Horne were testing the institute's new electron microscope by adding negative stain to dry phospholipids.
The resemblance to the plasmalemma was obvious, and the microscope pictures served as the first real evidence for the cell membrane being a bilayer lipid structure.
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MANUFECTURING:
The correct choice of liposome preparation method depends on the following parameters:
The physicochemical characteristics of the material to be entrapped and those of the liposomal ingredients;
The nature of the medium in which the lipid vesicles are dispersed
The effective concentration of the entrapped substance and its potential toxicity;
Additional processes involved during application/delivery of the vesicles;
Optimum size, polydispersity and shelf-life of the vesicles for the intended application; and,
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MANUFECTURING CONTT….
Batch-to-batch reproducibility and possibility of large-scale production of safe and efficient liposomal products
Example:Name Trade name Company Indication
Liposomal amphotericin B
Ambisome Gilead SciencesFungal and protozoal infections
Liposomal IRIV vaccine
Epaxal Crucell Hepatitis A
Liposomal IRIV vaccine
Inflexal V Berna Biotech Influenza
Liposomal vincristine
Marqibo Spectrum Pharmaceuticals
Acute Lymphoblastic Leukemia (ALL) and Melanoma
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APPLICATION: Applications of liposomes in the
sciences: Use of liposomes in cosmetics Use of liposomes in agro-food industry Use of liposome in pharmaceutical
industry: Example: Liposome Utility Current Applications Disease States
Treated
Sustained-Release Systemic antineoplastic
drugs, hormones
corticosteroids, drug
depot in the lungs
Cancer,
biotherapeutics
Solubilization Amphotericin B, minoxidil Fungal infections,
Accumolation Prostaglandins Cardiovascular
diseases
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MICROSPHERES AS DRUG DELIVERY SYSTEM
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DEFINATION Microspheres can be defined as solid, approximately
spherical particles ranging in size from 1 to 1000 μm.
Made up of polymeric, waxy, or other protective materials such as starches, gums, proteins, fats, and waxes and used as drug carrier matrices for drug delivery.
Microcapsules: micrometric reservoir systems Microspheres: micrometric matrix systems.
Natural polymer can also be used: Albumin Gelatin
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.
Drug CorePolymer Coat
= Polymer Matrix
} = Entrapped Drug
MICROCAPSULES MICROSPHERES •Microspheres are essentially spherical in shape, whereas, microcapsules may be spherical or non-spherical in shape.•Microparticles, either microcapsules or microspheres, as the same: ‘microcapsules’.
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ADVANTAGE OF MICROSPHERES
They facilitate accurate delivery of small quantities of potent drug and
reduced concentration of drug at site other than the target organ or tissue.
They provide protection for unstable drug before and after
administration, prior to their availability at the site of action.
They provide the ability to manipulate the in vivo action of the drug,
pharmacokinetic profile, tissue distribution and cellular interaction of the
drug.
They enable controlled release of drug.
• Ex: narcotic, antagonist, steroid hormones
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POLYMER USED FOR MICROSPHERES PREPARATIONS
Biodegradable
• Lactides & Glycolides and their copolymers
• Polyanhydrides• Polycynoacrylate
s
Non-biodegradable
• Poly methyl methacrylate
• Acrolein• Epoxy Polymer• Glycidyl
methacrylate
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PARAMETERS THAT CAN BE SATISFACTORILY CONTROLLED
Taste and odour masking
Conversion of oil and other liquids,
facilitating ease of handling
Protection of the drug from the
environment
Delay of volatilisation
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• Freedom from incompatibilities between
drug and excipients, especially the
buffers
• Improvement of flow properties
• Dispersion of water insoluble substance
in aqueous media
• Production of sustained release,
controlled release and targeted
medication
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METHODS OF PREPARATIONS
Solvent evaporation method
Single emulsion technique Double emulsion technique
Coacervation phase separation method
Spray drying and spray congealing method
Polymerization method
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ROUT OF ADMINISTRATION
Oral delivery Parenteral delivery
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MECHANISMS OF DRUG RELEASE
1. Degradation controlled monolithic system.
2. Diffusion controlled monolithic system.
3. Diffusion controlled reservoir system.
4. Erodible poly agent system.
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APPLICATIONS Microspheres in vaccine delivery.
Eg ; diphtheria toxoid , tetanus toxoid.
Targeted drug delivery. Eg ; ocular, eye (cornea).Etc
Controlled release. Eg ; gi tumors, bone tumors.
Chemoembolization.
Immuno microspheres
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Thank
you……