Routes of administration of Biotech products: Parenteral route considering Liposome and Microspheres

PRESENTED BY

MD. FOYSAL FUAD CHOWDHURY-11103099MD. RISAT ISLAM-11103116PROSENJIT MALLICK-11103118NRIPENDRA NATH BAIRAGI-10203070MOBIN AHAMMED HRIDOY-11103070JILANI RAHIM SARKAR-11103098

Topics to be discussed….1.BIOTECHNOLOGY

2.ROUTES OF ADMINISTRATION OF BIOTECH PRODUCTS

3.PARENTERAL ROUTE

4.MANIPULATION OF LIVING ORGANISMS

5.LIPOSOMES

6.MICROSPHERES

Biotechnology

THE APPLICATION OF SCIENCE AND TECHNOLOGY TO LIVING ORGANISMS, AS WELL AS PARTS, PRODUCTS AND MODELS THEREOF, TO ALTER LIVING OR NON-LIVING MATERIALS FOR THE PRODUCTION OF KNOWLEDGE, GOODS AND SERVICES.

1.DNA /RNA2. PROTEINS AND OTHER MOLECULES3. CELL AND TISSUE CULTURE AND ENGINEERING4.PROCESS BIOTECHNOLOGY TECHNIQUES5. GENE AND RNA VECTORS6. BIOINFORMATICS7. NANOBIOTECHNOLOGY

Biotechnology…….

Biotechnology technique

Routes of administration of Biotech products

Science has revealed its blessing to us with the chronological order. Biotechnology is one of the noteworthy consequence of long tern research, trial and error.Biotechnology enables us to exploit biological processes

for industrial and other purposes, especially the genetic manipulation of microorganisms for the production of antibiotics, hormones, etc.

The branches of biotechnology leaves us in different aspect with drugs of particular route in a certain dosage form.Oral Biotech products represnts a vast and common area of biotechnolical practice.

Biotech products

Route of administration

The path taken by the drug to get into the body is known as the route of drug administration. A drug may be in ionized or unionized form.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.

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.

Types of Parenteral Routes

1. Intravenous 2. Intra-arterial3. Intra-muscular injection4. Intrathecal5. Intraosseous infusion

 Advantages of Parenteral Administration: 

1. Rapid action of drug.2. Can be employed in unconscious/ uncooperative patients.3. Drugs, which are not absorbed in small intestine or irritate the stomach can be administered by this route.4. Drugs, which are modified by alimentary juices and liver can be given by this route.5. Does not have 1st pass metabolism.Polor drug can be given as they are absorbed, ( eg.- Streptomycin) 

Advantages of Parenteral Administration con……6. Can be used for drugs that are poorly absorbed, inactive or ineffective if given orally7. The IV route provides immediate onset of action8. The intramuscular and subcutaneous routes can be used to achieve slow or delayed onset of action9. Patient concordance problems can be avoided

Disadvantage of Parenteral Administration

1.Staff need additional training and assessment.2.Can be costly.3.Can be painful.4.Aseptic technique is required.5.May require additional equipment, for example programmable infusion devices6.Less safe, more expensive.7.Inconvenient (painful) for the patient.8.Self medication is difficult.9.Chances of local injury at the site of injection.10.It is difficult to reverse its physiological effect.

CHARACTERISTICS OF PARENTERAL ROUTE :1. The term “Parenteral” comes from two Greek words-‘ Para’ (outside) & ‘Enteron’ (intestine), meaning outside the intestine.2. It’s mechanism of drug absorption is for most drugs is passive transfer (eg.- ‘Levodoa’ follows carrier mediated transport).3. Drug can be directly enters systemic circulation.4. Does not have 1st pass metabolism.5. Onset of action is faster.6. Drug can be given unconscious & uncooperative patients.7. Polor drug can be given as they are absorbed ( eg.- Streptomycin)

MANIPULATION OF LIVING ORGANISM

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.

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

Biocompatibilty of parenteral dosage forms: 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"

Bioavailability and parenteral dosages forms vs oral dosage forms :

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.

Liposomes cont…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.

Liposomes cont…

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.

Mechanism of actionLiposomes are made of lipids.Cancer cells need to consume large amont of fats to sustain their estremely rapid growth.They recognize the liposomal drugs as a potential source of nutrition.Cancer cells absorb the liposomes loaded with anticancer drugs as asource of fat.Once the anticancer drugs released from the liposome in the cells are killed.

Manufacturing:

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 dispersedThe 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,

Manufacturing cont….Batch-to-batch reproducibility and possibility of large-scale production of safe and efficient liposomal productsExample:

Name Trade name Company IndicationLiposomal amphotericin B

Ambisome Gilead Sciences

Fungal and protozoal infections

Liposomal IRIV vaccine Epaxal Crucell Hepatitis A

Liposomal IRIV vaccine Inflexal V Berna Biotech Influenza

Liposomal vincristine Marqibo Spectrum Phar

maceuticals

Acute Lymphoblastic Leukemia (ALL) and Melanoma

Application:Applications of liposomes in the sciences:Use of liposomes in cosmeticsUse of liposomes in agro-food industryUse 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

MicrospheresMicrospheres 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 systemsMicrospheres: micrometric matrix systems.

Natural polymer can also be used: Albumin Gelatin

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

POLYMER USED FOR MICROSPHERES PREPARATIONS

Biodegradable

•Lactides & Glycolides and their copolymers•Polyanhydrides•Polycynoacrylates

Non-biodegradable•Poly methyl methacrylate•Acrolein•Epoxy Polymer•Glycidyl methacrylate

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

Parameters That can be satisfactorily Controlled CON….

• 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

METHODS OF PREPARATIONS Solvent evaporation method

Single emulsion techniqueDouble emulsion technique

Coacervation phase separation method

Spray drying and spray congealing method

Polymerization method

Mechanisms of drug release

1. Degradation controlled monolithic system.

2. Diffusion controlled monolithic system.

3. Diffusion controlled reservoir system.

4. Erodible poly agent system/erosion.

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

BIOCOMPATIBILTY OF MICROSPHERES

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