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Presentation On Route of administration of biotech product: Transdermal route considering Iontophoresis and Phonophoresis.

Abu Sayed Md. Kamrul Hasan Presented By Group Members Registration No. Mymona Akther Monni 13203007 Tanvir Ahmed 13203018 Abu Sayed Md. Kamrul Hasan 13203027 Kh M Nuruzzaman 13203038 Md Hasan Mahmud 13103097

Contents Biotechnology Biotech Product Methods to produce biotech products Routes of administration of biotech products Transdermal drug delivery  Generations of transdermal delivery system Iontophoresis mediated transdermal delivery of biotech product Phonophoresis mediated transdermal delivery of proteins Combination strategies Conclusions

Biotechnology The development and utilization of biological process, forms and systems For obtaining maximum benefits to man and other forms of life. Example: Recombinant DNA, Stem cell therapy, Cloning.

Biotech Products It is made by using biotechnical methods Biotech is the term used for biotechnology or products produced by biotechnology. It is made by using biotechnical methods To modify the genetic material of living cells To produce new substances or perform new functions.

Methods to produce biotech products Recombinant DNA technology Example: Insulin Fermentation Example: Cheese production Tissue or cell culture technology Example: Organ Culture, Whole embryo culture. Genetic engineering Example: Production of Somatostatin, Hepatitis-B vaccine

Routes of administration of biotech products Oral route Parenteral route Nasal route Transdermal

Transdermal drug delivery Transdermal drug delivery systems are dosage forms designed to deliver a therapeutically effective amount of drug across a patient’s skin also defined as medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the blood stream. An alternative to oral delivery and hypodermic injections. Example: Testosterone patch

Generations of transdermal delivery system First-generation transdermal delivery systems Second-generation transdermal delivery systems Third-generation transdermal delivery systems

First-generation transdermal delivery systems First-generation delivery candidates must be low-molecular weight, lipophilic and efficacious at low doses. should be more attractive than oral delivery due to low oral bioavailability. Example: Testosterone gels have been in use for several years and a transdermal spray has been recently approved for estradiol delivery

Second-generation transdermal delivery systems The second generation of transdermal delivery systems recognizes that skin permeability enhancement is needed to expand the scope of transdermal drugs. The ideal enhancer should Increase skin permeability by reversibly disrupting stratum corneum structure Avoid injury to deeper, living tissues.

Third-generation transdermal delivery systems Novel chemical enhancers, electroporation, cavitational ultrasound are used. More recently micro needles, thermal ablation and microdermabrasion have been shown to deliver macromolecules, including therapeutic proteins and vaccines, across the skin in human clinical trials.

Iontophoresis mediated transdermal delivery of biotech product Iontophoresis is a technique of introducing ionic medicinal compounds into the body through the skin by applying a local electric current. Charged drugs are moved via electrophoresis. weakly charged and uncharged compounds can be moved by electroosmotic flow of water.

Principles of Iontophoresis The rate of drug delivery can be readily controlled by a microprocessor. In this way, drug delivery can be turned on and off and even modulated over time to enable complex delivery profiles. Figure: Schematic diagram of the principles of Iontophoresis.

Advantages over other delivery system Fast skin recovery than parenteral route. Less risk of systemic absorption than injection. Less anxiety provoking or painful than injection Increases therapeutic efficacy by bypassing hepatic “first pass” metabolism.

Phonophoresis mediated transdermal delivery of proteins It has been used to enhance the delivery and absorption of topically applied biotech products through the therapeutic application of ultrasound.

Principles of phonophoresis It involves the application of low-frequency (20 kHz) ultrasound waves. It induces the air pockets present in the stratum corneum layer to oscillate, thereby creating cavities. Then increase permeability of skin. Fig: Principles of Phonophoresis

Applications Hormone Delivery. In surgery it helps in dissection, connection, built-up and treatment of biological tissue. Low-Frequency Ultrasonic Gene Delivery. It is also very useful in drug enhancement in granulomas and tumors. Ultrasound Helps in Treating Tennis Elbow and Tendon Problem.

Combination strategies Synergistic effect on drug delivery has been found in different combinations such as iontophoresis and microneedles, iontophoresis and chemical enhancers, iontophoresis and electroporation, microneedles, and sonophoresis. Pretreatment with chemical enhancers compromises the barrier properties of the skin and further application of iontophoresis enhances the movement of peptides into the skin.

Combination strategies Cont. Poration of skin followed by application of iontoporesis is another effective combination approach. For example: Daniplestim, a peptide was shown to have higher delivery levels after the combination treatment as compared with iontophoresis alone.

Conclusions Transdermal route for delivering bio-tech product is actively being pursued with several new emerging technologies that can now enable delivery of hydrophilic macromolecules across the skin. Some active enhancement products are currently available in the market and more products are in clinical trials/developmental stages.