Date post: | 21-Apr-2017 |
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Health & Medicine |
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TRENDS IN PHARMACEUTICAL
INDUSTRYBy:Darya Osman HusseinEman Salah AwadMoaz Ahmed Adam
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OVERVIEW
• Trend:• General development or change in conditions or
practices.
• In pharmacy:• Pharmaceutical growth or development to revolutionize
the health care system.
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• Advances in pharmaceutical industry generally targeted at improving efficiency of drug delivery, decreasing cost and improving bioavailability
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BIOSIMILARS
• A.K.A. follow-on biologic or subsequent entry biologic
• A medical product which is almost an identical copy of an original product manufactured by a different company
• Same idea as the “generic” type drugs but related to biological products (e.g. monoclonal antibodies, colony stimulating factors, etc.)
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• Issues may arise from several aspects:
1. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are genetically modified
2. Every biological (or biopharmaceutical products) displays a certain degree of variability, even between different batches of the same product, which is due to the inherent variability of the biological expression system and the manufacturing process
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3. It is currently tougher to get a biosimilar product past FDA regulators than their counterparts
4. Medical community concerned with complications, naming and licensing guidelines
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• Use of biosimilars may allow for 20-30% cheaper versions of biologic drugs therefore research into them is currently underway
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DIGITAL PHARMA
• Technological innovation allow patients to monitory their health and symptoms outside the clinical environment
• The importance of ‘beyond pill’ services allow better catering to patients needs
• ‘Digital medicine’ brought on various advances in drug composition
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• Example is the anti-psychotic drug Abilify (Aripiprazole) includes an ingestible sensor attached to pill
• Allows for monitoring of patient adherence to drug and will therefore allow for better clinical outcome
• Digital collaborations between pharma and tech are becoming more common everyday
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ADVANCEMENT IN DRUG DELIVERY
• Include research and development in various types of drug delivery and routes of administration
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DEVELOPMENTS IN INJECTABLE DELIVERY
• Injectable agents currently outnumber oral agents by approximately 30%
• In general this route considered as an unpleasant experience by many patients
• Generally tailoring involves consideration into two parameters:• Formulation• Device
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•Delivery device• Smaller needle• auto injectors
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MICRO ELECTRO MECHANICAL SYSTEM (MEMS)
• Preloaded with lyophilized/freeze dried drug in silicone rubber reservoir
• Drug delivered by processing device against skin for few seconds
• Drug pushed through microneedles into skin and absorbed via interstitial fluids into the bloodstream
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•Formulation alteration :
1. Can reduce frequency of administration
2. Reduce volume needed for injection
3. Reduce side effects (e.g. immunogenicity)
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PEGYLATING
• Significantly increases in vivo half life• Prevents attack by proteolytic enzymes
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HEPAROSAN CONJUGATES
• Heparosan polysaccharide sequences make up about 30% of the body's heparin sulfate (found in most cells/tissues) and heparin
• has no heparin sulfate or heparin-like biological activity.
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• By attaching synthetic heparosan to a drug molecule, an extended-release formulation similar to PEGylating can be created but with much less risk of an immunogenic reaction.
• Additionally, the half-life of a drug-heparosan conjugate can be easily customized by simply altering the defined size of the polymer
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MUCOSIS VACCINES
• Dutch biotechnology company developing trans mucosal administration of vaccines• Method is more patient friendly and give
superior immune response to vaccine
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• Theory is that vaccine is given via same route as pathogen invasion resulting in response similar to natural immune response
• Mucosally administered vaccines also elicit systemic and local immune response translating to improved protection.
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E.g. SynGEM – vaccine against RSV currently in preclinical testing
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TARGETED DRUG DELIVERY
• Improving delivery involves lower cost than discovery of new molecule
• Increase commercial opportunity by protecting product from “me too” drugs
• Allows branded drugs to be distinguished from generic competition
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ADVANCED COATING TECHNOLOGY
• Allow for delivery of targeted medications causing reduction of drug degradation, systemic side effects and more effective treatment • E.g. Multi Matrix MMX for
IBD• Uses pH resistant coating to
delay release of drug until reaches lower digestive tract
• Provides topical treatment at site of inflammation
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LIPOSOMAL DRUG DELIVERY
• Liposomal packaged drugs exhibit reduced toxicity and enhanced effectiveness
• Altered pharmacokinetics also allow for drug targeting and accumulation at disease sites reducing distribution
• Allows for sensitive tissue target delivery of drugs
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MONOCLONAL ANTIBODIES
• Act by binding to a specific antigen and inducing immunological response
• May prove to be very useful in targeting cancer cells while reducing harm to normal body cells
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NANOPARTICLE BASED DRUG DELIVERY
• Drug can be targeted to a precise location
• Results in increased effectiveness and reduced chance of possible side effects
• Nanocariers include:• Nanoparticles• Nano tubules • Nano shells
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SIGNIFICANT ADVANCES IN NANO DELIVERY
1. One dose a day Cipro using nanotechnology
2. Tumor targeted Taxol using nanoparticles
3. Improved ophthalmic delivery using smart hydrogel nanoparticles
4. Oral insulin using nanoparticle carriers
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CHALLENGES
1. Protect drugs from biological degradation
2. Effective targeting
3. Patient compliance
4. Cost effectiveness
5. Product life extension
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CARBON NANOTUBE
• Adept at entering the nuclei of cells and may one day be used to deliver drugs and vaccines
• So far only able to carry a small peptide into the nuclei of fibroblast cells
• Potential use in new anti-cancer treatments, gene therapies and vaccines
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GOLD NANOPARTICLES
• Used in cancer chemotherapy and act via free radical generation
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NANOERYTHROSOMES
• Resealed erythrocytes that carry protein, enzymes and macromolecules
• Used in treatment of liver, tumor and parasitic disease.
• Biocompatible (b/c use patients own erythrocytes), nontoxic and large space available for drug due to anucleation
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DENDRIMER
• Dendritic macromolecules (highly branched) which are used to encapsulated individual drug molecules (unimolecular Nano capsule)
• Can also act as attachment ‘hubs’ for large numbers of drug molecules attached via covalent bond
• E.g. anticancer agents 5-fluorouracil with polyaminoamine dendrimers
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MODIFIED BUCKY BALL
• Deliver radioactive atoms to cancerous cells
• Radiation is transferred within the ball therefore minimizing damage to healthy tissue
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NANO-ROBOTS
• Used in treatment of cancer
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• Designed to find and destroy only cancer cells
• Healthy cells remain unharmed
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FUTURE OPPORTUNITIES AND CHALLENGES
1. Nano-drug delivery systems that deliver large but highly localized quantities of drugs to specific areas to be released in controlled ways
2. Controllable release profiles, especially for sensitive drugs;
3. Materials for nanoparticles that are biocompatible and biodegradable;
4. Architectures / structures, such as biomimetic polymers, nanotubes
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5. Functions (active drug targeting, on-command delivery, intelligent drug release devices/ bioresponsive triggered systems, self-regulated delivery systems, systems interacting with the body, smart delivery)
6. Virus-like systems for intracellular delivery
7. Nanoparticles for tissue engineering; e.g. for the delivery of cytokines to control cellular growth and differentiation, and stimulate regeneration; or for coating implants with nanoparticles in biodegradable polymer layers for sustained release
8. Advanced polymeric carriers for the delivery of therapeutic peptide/proteins (biopharmaceutics),
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