Personalised medicines 1 (1)

personalized medicines
customized drug delivery
bioelectronic medicines
3D printing of pharmaceuticals
telepharmacy

1. PERSONALIZED MEDICINES Presented by MISS. JYOTI DIPAK MHOPREKAR M Pharmacy (First Year, Sem I) Roll No. 06 DEPARTMENT OF PHARMACEUTICS SHREE SANTKRUPA COLLEGE OF PHARMACY GHOGAON .

2. CONTENTS: Personalized medicines. Dosage forms for personalized medicines. Categories of patients for personalized medicines. Customized drug delivery systems. Bioelectronics Medicines 3D printing of pharmaceuticals Telepharmacy

3. PERSONALIZED MEDICINE: DEFINITION : Personalized medicine is defined as of medical treatment to the individual characteristics of each patient that not only improves our ability to diagnose and treat disease but offers the potential to detect disease at an earlier stage and to treat it effectively. Personalized medicines also referred as precision medicine holds great promise to improve health care. According to the “National cancer institute” personalized medicine integrates information about persons genes, proteins, diagnosis and treat diseases.

4. Simpler methods identify genetic information Less trial & error No toxicity It is the form of medicine that uses information from patients genotype to initiate a preventive measure against the development of disease or condition. Select the most appropriate therapy for a disease or condition that is suited to the patient.

5. DOSAGE FORMS FOR PERSONALIZED MEDICINES: Transdermal system Liquid oral form Solid dosage form Semisolid dosage form Topical dosage forms Combination dose system Thin film technologies

6. PHARMACOGENETICS : The effect of genetic variation on drug response, including disposition, safety, tolerability, efficacy. It is the study of how genetic difference in single influence the variability in drug response.

7. GOALS OF PHARMACOGENETICS : Maximize drug efficacy Minimize drug toxicity Predict patients who will respond to intervention. Aid in new drug development. BENEFITS OF PHARMACOGENETICS: More powerful medicines Safer drugs the first time More accurate methods to determine the dosages Better vaccines.

8. CURRENT USE OF PHARMACOGENETICS: Personalized medicine Determine drug response in treatment of cardiac, respiratory and psychiatric diseases Develop drug target in treatment of cancer Classify patient as slow and fast metabolizes of drugs. Gene therapy Drug response Drug targets Drug metabolism

9. CATEGORISE OF PATIENTS FOR PERSONALISED MEDICINES : Age related Disease related Genetically determined susceptibility Individual physiological status Specialized dosage form Drug targeting

10. CUSTOMIZED DRUG DELIVERY SYSTEM: INTRODUCTION : Customized drug delivery also termed as personalized medicines, is a medical procedure that separates patient into different groups- with medical decisions, practices, interventions and/or products to the individual patient based on their predicted response or risk of disease. The person: Their DNA Exposure of environmental factors Types and amount of stress they experiences What they eat

11. ADVANTAGES OF CUSTOMIZED MEDICINES : Better matching patients to drug instead of “trial and error”. Eliminate life threatening adverse reactions. Reduce cost of clinical trials by quickly identifying total failures and favorable response for particular backgrounds. Improved efficacy of drugs. Dosage can be controlled for the patients who need lower doses or with the needs of each individual patient. Any allergic creating ingredients can be skipped and a customized medicine can be produced for a particular individual.

12. TOOLS TO CUSTOMIZED DRUG DELIVERY SYSTEM : Bioelectronic medicines 3D printings of pharmaceuticals Telepharmacy

13. BIOELECTRONIC MEDICINE

14. BIOELECTRONIC MEDICINES: DEFINITION : Bioelectronic medicines are a tiny implanted device treating disease by changing the electronic impulses in nerves to and from specific organs. Potential for diagnosing and treating many diseases: Neurology Diabetes Autoimmune diseases Arthritis Hypertension Pain management Cancer

15. New era of medicines New way to understand the language of nervous system to perform advanced diagnosis. A tiny device that is attached to nerve that would adjust the electrical signals between the brain and the organs of our body. Bioelectronic medicines is a new approach to treat and diagnose disease and injury. Bioelectronic medicines uses device technology to read and modulate the electrical activity within the body’s nervous system, opening new doors to real time diagnostics and treatment options for patients.

16. HOW IT WORKS : Peripheral nerves send signals from the brain to the rest of the body. A device as small as or smaller than a grain of rice attaches to a nerve bundle. The device block or alters signaling patterns passing through individual nerve fibers. These modified signals travel to the target organ, treating diseases.

17. VARIOUS BIOELECTRONICS MEDICINES INSERTED LOCATION USES PACEMAKER: Heart pacemaker Brain pacemaker Heart (chest region) Brain Regulate heart beat ; treat arrhythmias. Treat Parkinson's disease; epileptics; tremors BIONIC EYE (bioelectronic eye) Eye Restore vision during retinal blindness ; zooming in an district object. BIOSENSORS: Body To monitor the body temperature and measure stress in specific parts COCHLEAR IMPLANT Attached to angle of mandible or jawbone To help profoundly deaf adults and children's who gets no benefit from hearing aids. ARTIFICIAL LIMBS Limbs Holding; control; capable of independent thought; modify and manipulate as per the needs. VARIOUS BIOELECTRONIC MEDICINES:

18. VARIOUS BIOELECTRONIC MEDICINES INSERTED LOCATION USES BIOLUNG: Lungs Exchange of gases ARTIFICIAL KIDNEY: Kidney Provide cleansing and fluid balance on continuous basis. HEPALIVER: (hepalife’s bioreactors) Liver Reduce level of toxic ammonia by 75% in fewer than 24hrs.i.e., detoxification; metabolism; secretion of biochemical's. ABICOR ARTIFICIAL HEART: Heart Used in patients who are close to death.

19. ADVANTAGES : The introduction of various revolutionary technique in medicine field makes less pain in approach to cure disease. These implants provide the targeted treatment ; by controlling the neural signals going to specific organs. Device would minimal or even zero side effects. It will avoid or overcome the problems faced by conventional dosage forms. It could be customerized for each patients to account for severity of disease for better patient compliance. These better results lead people more faith in modern medical sciences.

20. DISADVANTAGES: Costly process; if a signal part of chip is damaged the total technique will be meaningless. E.g., bionic eye. High compact state of nerve and cardiac systems, indiscriminate stimulator can lead to undesirable effects. Chances to get electrical shock. Installation of an implant may cause harm to our body.

21. 3D PRINTING PHARMACEUTICALS

22. 3D PRINTINGS OF PHARMACEUTICALS: INTRODUCTION : DEFINITION : 3D Printing technology relies on computer aided designs to achieve at most flexibility, time saving and exceptional manufacturing capability of pharmaceutical medicines. A single tablet containing multiple drug which means no need to take so many pills in a day a desired size and shape of tablet. 3D printings is layer by layer production of 3D objects from digital design. 3D printing a type of additive manufacturing has the potential to be the “next great step’’ in pharmaceutical manufacturing, enabling fabrication of specialty drugs and medical devices.

23. 3D printings can be used for personalized or unique dosage forms, more complex drug release profiles, and printing living tissue. 3D printing builds an object layer by layer, it can be used to print drug tablets with a personalizes dosage, possibly combining multiples drugs into a single dose. 3D printing process could minimize the cost. It can be used for customized drug delivery system.

24. PROCESS: Solidification

25. ADVANTAGES OF 3D PRINTING: High production rates due to its fast operating systems. Reduction of material wastage which can save in the cost of production. Ability to achieve high drug loading with much desired precision and accuracy especially for potent drugs that are applied in small doses. Treatment regimens must be customized to improve patient’s adherence to treatment.

26. CURRENT 3D PRINTING TECHNOLOGIES IN PHARMACEUTICAL DRUG DELIVERY: Inkjet printing Zip dose Thermal inkjet printing Fused deposition modeling

27. Inkjet printing: Powder is used as substrate for spreading ink which solidifies into solid dosage form. Different combination of active ingredients and excipients are precisely sprayed in small droplets which then solidifies into solid dosage form.

28. Zip dose: Provide a personalized dose in addition to delivery of high drug loaded with high disintegration and dissolution levels by manufacturing highly porous material .

29. 3) Thermal inkjet printing:

30. 4) Fused depositing modeling: Multiple dosage form is produced by applying polymer as apart of framework in this process polymer is melted and pass through a movable heated nozzle.

31. Examples of pharmaceutical formulations that were developed using 3D technology:

32. APPLICATIONS OF 3D PRINTING PHARMACEUTICALS: Tissue and organ fabrication Creating prosthetics, implants, and anatomical models. Pharmaceutical research concerning drug discovery, delivery and dosage forms. Flexibility in product development. Useful for designing for complex drug profiles.

33. TELEPHARMACY

34. TELEPHARMACY: DEFINITION : Telepharmacy means a central pharmacy, either retail or associated with a hospital , with one or more remote sites in which all sites are connected via computer , audio, and video link. Telepharmacy is the delivery of pharmaceutical care via telecommunication to patients have in locations where they may not have direct contact with a pharmacist Purpose and scope: In order to maintain or make pharmacy services available in areas that have lost their pharmacy or are in failure of losing their pharmacy , rules are necessary to permit telepharmacy.

35. OPERATIONS: The remote site is considered to be under the personal charge of pharmacist at the central pharmacy. A remote site shall be connected to its central pharmacy via computer link, video link , and audio link. A remote site should use its central pharmacy’s processing unit. A pharmacist at the central pharmacy must approve each prescription before it leaves the remote site. Counseling must be done by a pharmacist via video and audio link. The pharmacist must counsel the patient or the patients agent on all new prescriptions and refills. A pharmacist must complete monthly inspection of the remote site. Inspection reports must be included in the policies and procedure for the site. The inspection reports must be maintained until the next Board Of Pharmacy Inspection.

36. CATEGORIES OF TELEPHARMACY SERVICES Mail order Patient counseling by telephone Medication therapy management Collaborative drug management Central processing and remote order entry Remote supervision of technician dispensing Automated dispensing system

37. TYPES OF TELEPHARMACIES: Inpatient (remote order-entry review) Remote dispensing (retail/outpatient/discharge) IV admixtures Remote counseling

38. Inpatient (remote order-entry review): Definition: Inpatient telepharmacy refers to a pharmacist at a remote location performing remote order-entry services for an inpatient pharmacy at a hospital. The remote pharmacist reviews medication orders before the hospital staff administers the drugs to the patient. uses: Hospitals and health systems benefit from inpatient telepharmacy as it allows for real time medication order review and verification. With inpatient telepharmacy, remote pharmacists are able to provide 24/7 coverage hours to help supplement and strengthen the inpatient pharmacy.

39. 2) Remote dispensing (retail/outpatient/discharge): Definition: A remote dispensing site, or retail community telepharmacy, is a licensed brick and mortar pharmacy staffed by a certified pharmacy technician. A pharmacist supervises the technician, reviews prescriptions and performs his or her duties from a remote location via technology. Uses: It is used in retail community pharmacy and outpatient/discharge pharmacy settings, telepharmacy gives patients convenient access to a pharmacist and prescription medication.

40. 3) IV admixtures: Definition: The joint commission on accreditation of healthcare organizations (JCAHO) defines IV mixtures as, ‘the preparation of pharmaceutical product which requires the measured addition of a medication to a 50ml or greater bag or bottle of intravenous fluid.’ Uses: Hospital pharmacies can save time and money by implementing telepharmacy in the IV admixture clean room. They save the time needed to suit up and enter the clean room to review the solutions. Freeing up pharmacists time allows them to focus on clinical activities.

41. 4) Remote counseling: Definition: Remote patient counseling equates to pharmacists providing patient counseling and interactive video session, or by some means through telecommunications. Uses: Remote patient counseling allows pharmacists to consult and provide a variety of pharmacy care services to patients via secure, live video calls. Beyond being beneficial to retail independents, community, clinical and hospital based pharmacies, remote counseling also provides opportunities for specialty counseling, discharge counseling and various clinical interactions with pharmacists.

42. Advantages: Improve e fficiency ( reduce work load) Improve accuracy (reduce errors) Improve documentations Enhance security (authorized access only) Reduce job stress and staff turnover Improve timeliness for medication delivery

43. Disadvantages: Complexity and function variation Requires additional staff training and technical help Downtime system failure and inflexibility Cost and space issues