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Pressentation on Transdermal Patches
 

Pressentation on Transdermal Patches

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A  Transdermal Patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream.

A  Transdermal Patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream.

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    Pressentation on Transdermal Patches Pressentation on Transdermal Patches Presentation Transcript

    • By Shrikant Athavale Prathith Consultants Pune India 17-06-2013 1
    • Background A Transdermal Patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. Often, this promotes healing to an injured area of the body. An advantage of a transdermal drug delivery route over other types of medication delivery such as oral, topical, intravenous, intramuscular, etc. is that the patch provides a controlled release of the medication into the patient, usually through either a porous membrane covering a reservoir of medication or through body heat melting thin layers of medication embedded in the adhesive. 17-06-2013 2
    • Transdermal Patch Much more than a Surgical Tape Transdermal patches are simple to use into the bloodstream deliver drugs straight 17-06-2013 through the skin. 3
    • Medicines in pill form have a long, tortuous journey must go through the digestive system the liver must eventually eliminate them to get to destination 17-06-2013 they are absorbed into the blood they pass through the liver, before circulating to the rest of the body 4
    • Comparison of Medicine Travel Pill v/s Transdermal Medicines pill Transdermal 17-06-2013 5
    • Transdermal Drug Delivery Designing The essential Factors are Selection of Drug Drug Stability Polymer Selection Release Control Improvement of drug absorption 17-06-2013 Minimize Skin Irritation 6
    • Transdermal Drug Delivery Designing Polymer Selection The main polymers used are  silicone,  polyisobutylene and  acrylic ( most dominating ) 17-06-2013 7
    • Transdermal Drug Delivery Designing Release Control solubilizes, and solubilizing adjuvants 17-06-2013 8
    • Transdermal Drug Delivery Designing Improvement of drug absorption Transdermal absorption Enhancers Like Isopropyl myristate Oleyl alcohol 17-06-2013 9
    • Drug in Adhesive System Backing Adhesive with Drug Release Liner Simple DIA designs are popular, as they can be made by adding the drug and other components to the adhesive, mixing them, and then laminating them to a backing layer. 17-06-2013 10
    • Matrix System Backing Adhesive Drug reservoir Release Liner Liquid reservoir designs have the drawback of needing great precision in manufacturing to avoid the drugs leaking, 17-06-2013 11
    • Liquid Reservoir System Backing Drug reservoir Adhesive Rate Limiting membrane Release Liner while the extra membranes create a more complex manufacturing process. The matrix is often created by mixing a high concentration of drug into an adhesive, as high as 30 per cent, compared to around 5 per cent in DIA designs. 17-06-2013 12
    • Advantages of Transdermal Drug Delivery  do not put too much load on digestive system and liver  avoid the pain on injection  eliminate the adverse effects associated with excessive absorption of drugs taken orally  thereby alleviate anxiety  offer more comfort to patients  produce excellent prolonged effects  administration can be visually confirmed 17-06-2013 13
    • Transdermal Drug Delivery patches May cause side effects like o light headedness o dizziness o redness or irritation of the skin ( covered by the patch ) o flushing some other side effects cab be serious  slow or fast heart beat  worsening chest pain  fainting  rash  itching  difficulty in breathing or swallowing 17-06-2013 14
    • Transdermal Drug Delivery patches The patient can suffer a overdose symptoms of overdose may include 17-06-2013 • • • • • • • • • • • • • • Headache confusion Fever dizziness slow or pounding heartbeat nausea Vomiting fainting shortness of breath sweating Flushing cold and clammy skin loss of ability to move the body coma ( loss of consciousness for a period of time ) 15
    • Applications of Transdermal Patches Treatment of Ischemic Heart Disease TDD with isosorbide dinitrade contain in adhesive treats ischemic heart diseases such as angina pectoris, when applied on chest or upper abdomen release the drug contribute to therapeutic improvement of cardic function. For Local Anesthesia with tulobuterol ( Respiratory function has a circadian rhythem and is known to decrease from around midnight to early morning , generally known as "morning dip" paients suffering from bronchial asthma, accacks often occur in the early morning , caused by morning dip, is a major stress factor this patch offers a long lasting brochodilating effect 17-06-2013 16
    • Special precautions when using transdermal patches • apply patch to clean, dry, unbroken skin • apply patch firmly ( it may take 20-30 seconds to get it stick firmly in place) • wash your hands after applying • use only one patch at a time • if ou need to conduct MRI test , the patch may need to be removed • if you develop skin irritation ( due to adhesive ) , appy the next patch on another area • when you remove the skin patch, fold it so the adhesive edges stick together • gently wash the area with soap and water 17-06-2013 17
    • The main Components The main components to a transdermal patch are: Liner - Protects the patch during storage. The liner is removed prior to use. Drug Drug solution in direct contact with release liner Adhesive Serves to adhere the components of the patch together along with adhering the patch to the skin Membrane - Controls the release of the drug from the reservoir and multi-layer patches Backing Protects the patch from the outer environment 17-06-2013 18
    • There are five main types of transdermal patches. Single-layer Drug-in-Adhesive Multi-layer Drug-in-Adhesive Reservoir Matrix Vapour Patch 17-06-2013 19
    • Single-layer Drug-in-Adhesive The adhesive layer of this system also contains the drug. In this type of patch the adhesive layer not only serves to adhere the various layers together, along with the entire system to the skin, but is also responsible for the releasing of the drug. The adhesive layer is surrounded by a temporary liner and a backing. 17-06-2013 20
    • Multi-layer Drug-in-Adhesive The multi-layer drug-in adhesive patch is similar to the singlelayer system in that both adhesive layers are also responsible for the releasing of the drug.One of the layers is for immediate release of the drug and other layer is for control release of drug from the reservoir. The multi-layer system is different however that it adds another layer of drug-in-adhesive, usually separated by a membrane (but not in all cases). This patch also has a temporary liner-layer and a permanent backing. 17-06-2013 21
    • Reservoir Unlike the Single-layer and Multi-layer Drug-in-adhesive systems the reservoir transdermal system has a separate drug layer. The drug layer is a liquid compartment containing a drug solution or suspension separated by the adhesive layer. This patch is also backed by the backing layer. In this type of system the rate of release is zero order. 17-06-2013 22
    • Matrix The Matrix system has a drug layer of a semisolid matrix containing a drug solution or suspension. The adhesive layer in this patch surrounds the drug layer partially overlaying it. Also known as a monolithic device. 17-06-2013 23
    • Vapour Patch In this type of patch the adhesive layer not only serves to adhere the various layers together but also to release vapour. The vapour patches are new on the market and they release essential oils for up to 6 hours. The vapour patches release essential oils and are used in cases of decongestion mainly. Other vapour patches on the market are controller vapour patches that improve the quality of sleep. Vapour patches that reduce the quantity of cigarettes that one smokes in a month are also available on the market. 17-06-2013 24
    • Popular uses The highest selling transdermal patch in USA is the nicotine patch, Hormonal patches Estrogen patches contraceptive patch testosterone patches for both men and women Nitroglycerin patches Transdermal scopolamine The anti-hypertensive drug Clonidine Vitamin B12 may also be administered through a transdermal patch. 17-06-2013 25
    • Scope of our Supply 1. 2. 3. 4. The Complete Plant and Machinery for manufacturing The Adhesive formulations The Raw Material sources The Manufacturing Process parameters Not in our Scope 1. The FDA approval 2. Other Govt. approvals if any necessary 17-06-2013 26
    • The Details of the Plant and Machinery , supplied by us 17-06-2013 27
    • The Manufacturing Process  The preparation and homogeneity of the bulk drug containing or non bulk drug containing adhesive mass  the coating process , including those parameters to control layer thickness  drying , curing and removal of residual solvent  lamination steps  the storage and handling of intermediate rolls  roll conversion to patches  primary packing 17-06-2013 28
    • The Coating machine We offer a Fully automatic Programmable Machine Designed as per GMP Standards , Complete Stainless Steel Construction Inside , provided with clean Room facility 17-06-2013 29
    • The Coating machine Specifications Pl refer MS Word File attached 17-06-2013 30
    • The Coating machine Capacity Installed Coating plant Capacity / Shift of 8 Hrs Capacity / PM ( one Shift of 8 Hrs/ Day ) : 3,600 sq. Mtrs : 90,000 sq. Mtrs Die Cuts into patches ( gen size 50 mm X 75 mm ) Capacity / Shift of 8 Hrs : 3,20,000 Nos. Capacity / PM ( one Shift of 8 Hrs/ Day ) : 80,00,000 Nos. 17-06-2013 31
    • The Supporting Machines ( Production ) 1. 2. 3. 4. 5. 17-06-2013 Adhesive Blending Slitting Machine Slicing Machine Die Cutting Machine Shrink Warp 32
    • The Supporting Machines ( Testing ) 1. Complete set of Testing equipment's for Transdermal Patch and Surgical tape Manufacturing. The same is not in our Scope of supply 17-06-2013 33
    • The Installed Plant Location , where Contract manufacturing is Possible This Plant is Located in North Karnataka about 460 KM south of Mumbai . We will share the details at a appropriate time 17-06-2013 34
    • Our Comments on your points 1. Comparative analysis between contract manufacturing and own production setup with a working on capital and operational costs The approximate Contract Manufacturing , cost per sq. mtr. will be Rs. 40 - 45 ( Exclusive of Raw material Cost ) , The same will be around Rs. 15 per sq. mtr if you manufacture in house. Capital investment will be approximately , Rs. Lakhs. Working Capital will depend on the production quantity in sq. mtr. / PM 17-06-2013 35
    • Our Comments on your points 2. Liasoning with prospective contract manufacturers, if that route is preferred. This is also possible. We have spoken to the Manufacturer and he is ready for Contract Manufacturing 17-06-2013 36
    • 3. Putting together a production unit with machinery, if an own unit is to be set up This is also possible. We will offer you a suitable plant and Machinery , for manufacturing. 4. Setting up a supply chain for raw materials (other than active pharmaceutical drugs); agreements with preferred suppliers We will assist you in providing Raw Material manufacturers contact details. 17-06-2013 37
    • 5. Assistance in formulations of new products We will take care of this , and assist you with formulations. 17-06-2013 38
    • The Products of your Interest Transdermal products: 1. Elastic Bandages and Patches for relief from Injury pain, inflammation and swelling We will help you in Adhesive formulations for the same. The suitable Drug additive for the same to be supplied by you. 2. Nasal patches for relief from nasal congestion, cold etc. We will help you in Adhesive formulations for the same. The suitable Drug additive for the same to be supplied by you. 17-06-2013 39
    • The Products of your Interest Transdermal products: 3. Elastic Bandages and Patches for relief from Joint Pain, Arthritis, Rheumatism etc. We will help you in Adhesive formulations for the same. The suitable Drug additive for the same to be supplied by you. 4. Patches for relief from Headache, Fever, Anxiety, Sleep Deprivation etc. We will help you in Adhesive formulations for the same. The suitable Drug additive for the same to be supplied by you. 17-06-2013 40
    • The Products of your Interest Transdermal products: 5. Patches for Motion Sickness We will help you in Adhesive formulations for the same. The suitable Drug additive for the same to be supplied by you. 6. Hydrogel Cosmetic Masks and Psoriasis Patches for lesions due to dry and scale skin We will help you in Adhesive formulations for the same. The suitable Drug additive for the same to be supplied by you. 17-06-2013 41
    • Types of Transdermal patches available today         17-06-2013 transdermal patch Nicotine transdermal patch for severe pain transdermal patch for harmone theorapy transdermal patch anti hypertensive transdermal patch anti depressant transdermal patch deficit hyper activity disorder transdermal patch vitamin b12 transdermal patch easy breath 42
    • Types of Transdermal patches available today  Transdermal patch Nicotine Nicorette Patch helps to give up smoking by relieving the desire to smoke, and some of the unpleasant effects which smokers experience when they stop smoking. To successfully become a non-smoker it is important to understand how Nicorette Patch works. 17-06-2013 43
    •  Transdermal patch for severe pain A transdermal analgesic or pain relief patch is a medicated adhesive patch used to relieve minor to severe pain. There are two primary types of analgesic patches: patches containing counterirritants, which are used to treat mild to moderate pain, and patches containing fentanyl, a narcotic used to relieve moderate to severe pain in opioid-tolerant patients. 17-06-2013 44
    •  Transdermal patch for hormone therapy 17-06-2013 45
    •  transdermal patch anti hypertensive Hypertension is one of the largest deaths causing disease for the mankind. Since it is a chronic disease it necessitates long term treatment. Depending on the release required over a period of time, the concentrations of polymer, plasticizer and penetrant were varied. 17-06-2013 46
    • Transdermal patch anti depressant Is a transdermal patch containing the Selegiline, in small doses, is most commonly used in the treatment of Parkinson's disease. It is also effective in higher doses for the treatment of major depressive disorder. The patch "is a matrix containing three layers consisting of a backing, an... adhesive drug layer, and a release liner that is placed against the skin. 17-06-2013 47
    •  Transdermal patch deficit hyper activity disorder ADHD (attention deficit hyperactivity disorder) is the most common behavioural disorder that starts during childhood. However, it does not only affect children - people of all ages can suffer from ADHD. Psychiatrists say ADHD is a neurobehavioral developmental disorder. 17-06-2013 48
    •  Transdermal patch Vitamin B12 17-06-2013 49
    • Transdermal patch Easy Breath When you suffer from nasal congestion, it affects your whole day. Breathe Right helps you breathe better so you can sleep better and feel better all day long. When placed correctly, Breathe Right nasal strips provide: Nasal congestion relief due to the common cold or allergies Better breathing for people with a deviated septum Snoring relief due to night time nasal congestion 17-06-2013 50
    • Photo Gallery A 21mg dose Nicoderm CQ patch applied to the left arm Contraceptive patch Clonidine tablets and transdermal patch 17-06-2013 51
    • Background Please feel free to contact us For more Information Our website Personal Email Cell 17-06-2013 : www.psadhesive.com : psatechno@gmail.com : 00 91 9850242282 52
    • 17-06-2013 53