Novel drug delivery system

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this ppt includes all drugs, their modification to improve their absorption, devices to enhance delivery of drug with newer treatment modalities.

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By: abhipray (28 month(s) ago)

sir myself Drabhijeet bhagat MD pharmacology , needed u r ppt for seminar please send to my email drabhhi@gmail,com

By: hiteshpatel383 (29 month(s) ago)

hi sarita i need ur ppt for my project work can you send to me on hiteshpatel383@gmail.com

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Novel drug delivery systems Dr. Sarita R. Jaiswar Grant medical college & sir j.j . group of Hospitals, Mumbai

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There are great opportunities for companies investing in R&D for new, improved drug delivery system, allowing for improved therapeutic absorption and efficacy in patients. Novel drug delivery is one of the fastest growing healthcare sectors, with sales of drugs incorporating novel drug delivery systems increasing @ an annual rate of 15% By 2011, the US drug delivery market alone will be worth $30 billion.

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Why Novel Drug Delivery system? To optimize drug’s therapeutic effect, convenience and dose. To enhance a product’s life-cycle To improve `patient compliance To target drug delivery To control overall healthcare costs To facilitate biological drug delivery

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Novel drug delivery system Specialized drug delivery system Inhalational/Pulmonary drug delivery system Transdermal drug delivery system Injection based drug delivery system Oral drug delivery system GI specific drug delivery system

Oral drug delivery system: 

Oral drug delivery system Formulation ranges from simple tablets to newer modified controlled release tablets. Involve use of various polymers, Metrics and hydrogel based formulations. Various modification in oral drug delivery depends upon - Dissolution – diffusion controlled release system - Osmotic pressure controlled system - Microsphere Based technology - Novel packaging

Dissolution & Diffusion Controlled Release system: 

Dissolution & Diffusion Controlled Release system Drug encased in a partially soluble membrane. Pores are created due to dissolution of parts of membrane. It permits entry of aqueous medium into core & drug dissolution. Diffusion of dissolved drug out of system. Ex- Ethyl cellulose & PVP mixture dissolves in water & create pores of insoluble ethyl cellulose membrane . Insoluble membrane Pore created by dissolution of soluble fraction of membrane Entry of dissolution fluid Drug diffusion

Osmotic Pressure Controlled System: 

Osmotic Pressure Controlled System Provides zero order release. Two compartments separated by movable partition. Osmotically active compartment absorbs water from GIT. Creates osmotic pressure. Partition moves upward & then drug releases. Ex: Nifedipine .

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MacroCap ( Biovail Corporation International, Canada) Micropump Oral Controlled Delivery System ( Flamel Technologies, France) Zer -Os tablet technology (ADD Drug Delivery Technologies AG, Switzerland) Various technology for improving bioavailability Micropump Oral Controlled Delivery System ( Flamel Technologies, France) for drugs with extend absorption time. Microparticle : Diameter: 200 and 400 m m Bioadhesive surface. Drug release – under osmotic pressure. Modulation of polymer coating and thickness.

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Ceform microsphere technology ( Fuisz Technology Ltd., USA) DUREDAS or Dual Release Drug Absorption System ( Elan Corporation) PRODAS or Programmable Oral Drug Absorption System ( Elan Corporation) Various technology for improving bioavailability DPHS or Delayed Pulsatile Hydrogel System ( Andrx Pharmaceuticals) Ceform microsphere technology ( Fuisz Technology Ltd., USA) Microspheres of pharmaceutical compounds. Used in a wide variety of dosage forms, including tablets, capsules, suspensions, effervescent tablets, and sachets. Formulated for enhanced absorption ( Ceform EA) or taste isolation ( Ceform TI) and controlled release ( Ceform CR).

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Mouth dissolving tablets Immediate release of drug particle. Quick absorption and assimilation in body E.g. Loratidine , Ofloxacin , Ondensetron .

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Gastrointestinal specific drug delivery system

Approaches for prolonging the gastric residence time: 

Approaches for prolonging the gastric residence time For sustained release of drugs in GIT. Various approaches for prolonging GI residence time. - Use of passage delaying excipients . - Gas generating system - Superporous Hydrogel - Mucoadhesive system

Gas-generating systems : 

Gas-generating systems

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On the left, superporous hydrogel in its dry (a) and water-swollen (b) state. On the right, schematic illustration of the transit of superporous hydrogel . Superporous Hydrogels

Mucoadhesive or bioadhesive systems : 

Mucoadhesive or bioadhesive systems Involves wetting, adsorption and interpenetration of polymer chains. Examples for Materials commonly used for adhesion are polyacrylic acid, chitosan , Polymethyl vinyl ether/ maleic anhydride copolymers, cholestyramine , tragacanth , sodium alginate. the rapid turnover of mucus in the gastrointestinal tract is the main problem

Colon targeted drug delivery: 

Colon targeted drug delivery The topical treatment of CA colon and IBD. many colon-specific dosage forms have been developed, including prodrugs , cross-linked hydrogels , matrices, and coated dosage forms. Coated dosage forms are preferred. The pH-controlled release coatings that are insoluble at the lower pH of the stomach and dissolve in the lumen of the small intestine in the pH between 6 -7.

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Technologies used in formulation of colon targeted drug delivery Oros -CT ( Alza Corporation) once- or twice-a-day colon-targeted dosage form based on the principles of osmotic pressure Colon Specific Systems (Advanced Polymer Systems, Inc.) Microsponge systems to protect the active agent from the environment of the stomach and delivers the drug to the colon in a controlled fashion. Pulsincap (R.P. Scherer) consists of a water-insoluble capsule body and a water soluble cap. The soluble cap dissolves in the intestine, thereby allowing the hydrogel plug to swell and expand. .

Injectable drug delivery system: 

Injectable drug delivery system The administration of drug by other than oral route. The major route of parenteral drug delivery – Intravenous, Subcutaneous, Intramuscular. Predictable mode of drug delivery. Modification in devices and infusion rate controlled delivery.

Insulin delivery: 

Insulin delivery Insulin Pens

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Insulin Pumps

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Bone marrow injection – stem cell transplant The use of intramyocardial injection of autologous bone-marrow cells in patients with chronic myocardial. significant but modest improvements in perfusion, left ventricular function and anginal symptoms

Inhalational drug delivery system: 

Inhalational drug delivery system A fastest growing drug delivery system with an annual growth of 11% for locally acting drugs & 30% for systemically acting drugs. Attractive for delicate molecules allowing systemic administration without significant degradation. offers flexibility for multiple formulations ranging from nasal drop to suspension spray. A bright prospect for site-specific delivery of biotechnological products such as Insulin & other hormones.

Inhalation/pulmonary drug delivery system : 

Inhalation/pulmonary drug delivery system  Metered dose inhalers  Dry powder inhalers  Inhalation nasal sprays  Inhalation solutions & suspensions (for nebulizers )

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A hand-held device that delivers doses of medication to the lungs of a patient using propellants. the treatment of asthma, chronic obstructive pulmonary disease and other respiratory diseases. A metered-dose inhaler

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Insulin spray

Transdermal drug delivery system: 

Transdermal drug delivery system Transdermal delivery provides a leading edge over injectables and oral routes by increasing patient compliance. C ontrolled , constant administration of the drug , allows continuous input of drugs with short biological half-lives. Fine microneedle usage - not painful. Limitation of hepatic first pass metabolism. The first Transdermal system, Transderm -SCOP.

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Single layer drug in adhesive Multi -layer drug in adhesive Reservoir system Micro reservoir system Vapour patch Matrix system

For improving absorption of drugs: 

For improving absorption of drugs Use of penetration enhancers and prodrugs . Physical techniques -- Iontophoresis -- Electrophoresis -- Sonophoresis -- Use of fine M icroneedle .

Various technologies used : 

Various technologies used Dermaflex ( Elan Corporation ) Dermasite (KV Pharmaceuticals ) D-trans ( Alza Corporation ) E-trans ( Alza Corporation ) Microsponge systems (Advanced Polymer Systems Inc., USA ) Polytrap systems (Advanced Polymer Systems Inc .) TheraDerm -LRS and MTX ( Theratech , Inc., USA ) Therapatch ( Theratech Inc.) TheraDerm -LRS ( Theratech , Inc., USA) is a liquid reservoir system - Not rate limiting. the drug reservoir is isolated physically from the adhesive within the system . TheraDerm -MTX ( Theratech Inc.) is a matrix system based on an adhesive matrix patch design. The drug is incorporated into the adhesive, resulting in a light and flexible patch that conforms to the skin for maximum adhesion and comfort.

Coated implantable drug delivery: 

Coated implantable drug delivery Permit localised drug delivery from implant. Location of implant after insertion - possible. Action for prolonged duration. MEMS implantable drug delivery systems. Maintains a dosage level very close to the target rate. E.g. Hormonal delivery to endometrium from intrauterine devices , Sirolimus coated stents in coronary arteries.

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Targeted drug delivery

What do we mean by drug targeted delivery ?: 

What do we mean by drug targeted delivery ?

Monoclonal antibodies - targeted drug delivery: 

Monoclonal antibodies - targeted drug delivery mAbs act directly when binding to a cancer specific antigens and induce immunological response to cancer cells Such as inducing cancer cell apoptosis, inhibiting growth, or interfering with a key function . mAbs was modified for delivery of a toxin , radioisotope , cytokine or other active conjugatates . Large no. of drug are employed including Human and chimerical forms.

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Monoclonal antibodies and their targets Drugs Targets Muromonab-CD3 glycoprotein CD3 antigen of human T cells. Daclizumab to the  subunit of IL-2 receptor on T cells Basiliximab CD25 ( α -subunit chain of IL-2 receptor on activated lymphocytes) Adalimumab anti-TNF mAb Anakinra Human IL-1 receptor antagonist Rituximab CD20 Alemtuzumab CD52 trastuzumab HER2 receptor Efalizumab Lymphocyte Function Associated Antigen -1

Liposomal drug delivery : 

Liposomal drug delivery P re-clinical and clinical – liposomal packed drugs exhibit reduced toxicities with enhanced efficacy. Due to altered pharmacokinetics – drug accumulation at disease sites and reduced distribution to sensitive tissue – targeted delivery of drugs .

Discovery of liposomal Amphotericin B: 

Discovery of liposomal Amphotericin B Acute toxicities of conventional drug markedly reduced with liposomal amphotericin. No loss of broad-spectrum antifungal activity. The possible mechanisms for reduced toxicities - altered pharmacokinetics and increased association with high-density lipoproteins. Liposomal amphotericin B - treatment of systemic Candida albicans or Cryptococcus neoformans infection.

Application of liposomal drug delivery: 

Application of liposomal drug delivery liposomal Doxorubicin – significantly reduces the drug associated cardiotoxicities . liposomal vincristine – prolonged expression of neoplastic cells, increased drug retention and increased circulation leads to improved efficacy. liposomal IL -7 – improve antibodies titer ,enhanced immunogenicity due to prolonged release ( over 6 days) liposomal Nucleotide – Protect them from degradation by nuclease and complement system. liposomal Gene transfer – CFTR gene to nasal epithelium of cystic fibrosis patients – under phase 1 trial liposomal IL -2 – approved for renal carcinoma.

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This formulation showed a satisfactory drug loading for isoniazid and pyrazinamid , but the incorporation of ethionamide , streptomycin and rifampicin was not successful

Nanoparticle based drug delivery: 

Nanoparticle based drug delivery Using nanotechnology, the drug can be targeted to a precise location which would make the drug much more effective and reduce the chances of possible side-effects. The primary goal for research of nanobiotechnology in drug delivery include – more specific drug targeting and delivery, reduction in toxicities while maintaining therapeutic efficiency , greater safety and biocompatibilities, faster development of safe drugs. Nanocarrier – nanoparticle , naonotube , nanoshell etc.

Applications: 

Applications N anoparticles are promising tools for the advancement of drug delivery. Nanoshells that concentrate the heat from infrared light to destroy cancer cells with minimal damage to surrounding healthy cells. Nanotubes used in broken bones to provide a structure for new bone material to grow . Nanoparticle pulmonary drug delivery – improved efficiency Nanoparticles that can attach to cells infected with various diseases - hence identification of diseased part.

Engineered Nanotechnologies - Applications and hazardous: 

Engineered Nanotechnologies - Applications and hazardous Gold nanaparticles – cancer chemotherapy Free radical generation Carbon nanotubes – for bronchial asthma ADR: Foreign body granuloma , interstitial fibrosis, lung toxicities.

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Quatum dots –for identification drug traces in body via MRI. Toxicities due to coating – leads to free radical generation.

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Nanoerythrosomes are erythrocytes based new drug carrier. prepared by extrusion of erythrocyte ghosts to produce small vesicles. an average diameter of 100nm. Administered IV or intra – arterial. Modified Blood cells - Nanoerythrosomes

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APPLICATIONS They can target the drugs within reticulo endothelial system. Carriers for drugs , proteins , enzymes ,macromolecules. Treatment of liver tumors, parasitic diseases, enzyme deficiency. FUTURE PERSPECTIVES A large amount of valuable work is needed so as to utilize the potentials of nanoerythrosomes Disease like cancer could surely find its cure with the help of nanoerythrosomes . Genetic engineering aspects can be coupled to give newer dimension to the existing drug carrier concept.

Genetic transfer system : 

Genetic transfer system Gene therapy is also likely to be one of the most exciting growth sectors as biotech companies become involved in drug delivery. Currently, very few are in Phase III clinical trials. Gene transfer by various nanoformulation are still under evaluation. Two methods – viral and non viral gene transfer. At present – gene transfer with use of adenovirus and processed HIV as vectors. Complicated procedure

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Schematic overview of Gene transfer

Non viral transfer of genetic material: 

Non viral transfer of genetic material Luciferase (Luc) transgene activity in salivary glandsultra sound-assisted gene transfer (UAGT) -

Looking to the horizon: 

Looking to the horizon Continuous growth of R/D. Beyond traditional polymer network to find out the new innovative drug receptor system. Leading towards various nanoformulations . Newer cutting edge technology - Dendrimers - Modified buckyballs .

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Dendrimers Biocompatible and biodegradable Highly branched globular synthetic macromolecules. Size and structure can be controlled. Serve as hub onto large no. of drugs can be delivered e.g. 5 – FU combined with polyamino dendrimers and Methotrexate combined with hydrazide terminated dendrimers .

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Modified buckyballs Metallofullerenes material. Deliver radioactive atoms to cancerous tissue Transport atoms within balls hence minimise stray radiation to healthy tissue. As radiocontrast agents in MRI e.g. C -60 against colonic carcinoma

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Current Challenges Materials for nanoparticles that are biocompatible and biodegradable. Active drug targeting, on-command delivery, intelligent drug release devices/ bioresponsive triggered systems, self-regulated delivery systems. Universal formulation schemes that can be used as intravenous, intramuscular or per oral drugs. Cell and gene targeting systems. Controllable release profiles, especially for sensitive drugs.

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Future opportunities Nanoparticles provide massive advantages regarding drug targeting, delivery with additional potential to combine diagnosis and therapy. Anti-tumour therapy, gene therapy, AIDS therapy, radiotherapy. Involved in the delivery of proteins, antibiotics, virostatics , vaccines and as vesicles to pass the blood-brain barrier.

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Conclusion The market for drug delivery systems has come a long way and will continue to grow at an impressive rate. Today’s drug delivery technologies enable the incorporation of drug molecules into new delivery systems, thus providing numerous therapeutic and commercial advantages. Tomorrow’s drugs definitely will be more challenging in terms of the development of delivery systems and pharmaceutical scientists will have to be ready for a difficult task ahead.

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Thank you