Opioid patches have become increasingly popular among doctors and patients – due to good pain relief with reduced side effects. Money can now expect the first generic Fentanyl Patch pain: One of the top selling drugs in Germany (€ 335 million) with fentanyl TTS Hexal® found a better imitators market since August 15 The fentanyl patch deposit take to reach the patch of the matrix.
Fentanyl, a synthetic opioid, is used for severe chronic pain and very severe. Mu receptor agonists is about 100 times stronger than morphine. For the fentanyl group, they include fentanyl, alfentanil, sufentanil and remifentanil, all substances that fall under the Narcotics Act.
Strong protection against pain
Fentanyl has been used for decades as a Narco analgesic during operation. The substance is a tablet, an injectable solution, and since 1995 as a transdermal therapeutic system. Chronic diseases – more than six months now – pain, which is mainly used in applications in oncology, increasingly as co-medication for osteoarthritis, osteoporosis and rheumatoid arthritis, “said the Prof. anesthetist E. Koch, Munich. Transdermal fentanyl – acts contrary to previous expectations – also in some forms of neuropathic pain such as diabetic neuropathy or neuralgia Postzoster.Fentanyl should be lower at high doses of morphine to obtain the effect of analgesia. There are also indications of a lower tolerance development of potent opioids, such as fentanyl compared with morphine.
Why a patch for the pain?
The side effects of opioids critical, even if properly conducted chronic pain, motility disorders, and constipation. To avoid drug released the TTS through the intestine, constipation is 30 to 50% below fentanyl reduced compared morphine. For compatibility with the fentanyl transdermal administration in the control can be achieved with better oral treatment of chronic pain of pain, morphine was the food. People with severe chronic pain, until the patch to make life easier. Instead of tablets several times a day in the section of a patch of pain must be replaced every three days. The long-term analgesia provides greater independence to the patient.The advantages are certain peculiarities of the opposite side: the plasma drug concentrations at steady state occur only twelve to 24 hours after gluing. For the treatment of acute pain, the patch is totally inadequate. The system also allows to adjust the dose is fast, which is reserved for patients with a stable level of pain. For Kupierung pain points are required with immediate release morphine formulations in general. For high fever and heat more external drug is also released patch.
From the patch matrix reservoir
Despite all the advantages of the reservoir patch some leaks were observed in the system words of Dr. K. Kramer, Project Manager Hexal, Durogesic® original supplier. “It was finally led to the cancellation of the highly successful brewing tank of the German market and the introduction of the die part Durogesic® SMAT®,” said Kramer. To avoid drying or loss of Hexal used pellets shutter house development fentanyl TTS Hexal® double border. However, the total size of the patch against the first part has been reduced by about one-fifth of the same version. adhesion properties and improved storage stability. the fentanyl Hexal® can be between 2 ° C and 40 ° C are in contrast to the original supplier (storage at 15 to 25 ° C) to prevent a specific storage stored notes.
In parallel with the tank part, a matrix dosage form was developed, which contains in the adhesive layer of the active agent. The patch of the matrix is very thin, barely noticeable skin cosmetically discreet. It has a strong patient acceptance. However, the deposit system still has its importance, visibility and scripturality (presentation), especially in patients in nursing homes, a security benefit (see. Inset).
The pharmacokinetics of the reservoir and matrix patch Hexal tested against editor patch Durogesic® initial deposit, so Kramer. Exit rates correspond to single and multiple doses and control the criteria for bioequivalence (80-125%).
After the expiry of July 2005 in the patent system fentanyl patches, Hexal generics launched its filing system in the same dosage strengths (release 25, 50, 75 and 100 micrograms fentanyl / time) the August 15, 2005 on the market. In a corresponding matrix system Hexal approval and expects the BfArM Placet yet so Strüngmann, CEO of Hexal AG this fall. The following year (Ratiopharm Stada, ts) was the entry on the market is expected that other manufacturers.Durogesic® packages will be sold at the selling price of the pharmacy of about € 335 million currently 1.6 million per year, calculated before Glaeske professor. In the regulations, at the expense of the GKV account for about 1.5 million parcels, it costs about € 310 million (€ 24 billion spending SHI on drugs, which is about 1.3%!). generic patches that are now available are technologically innovative and offer a discount of about 20%, ergo saving potential of about 60 million.
Application Error Warning!
To misapplications occur when patches of pain, so after the first patch too early for a second stuck in a patch (especially the barely visible matrix patch) is not removed before the next used when tank plaster and damaged or center cut expire concentrated and can be absorbed through the skin.This abuse is associated with the use of fentanyl patches to all the available evidence of the reason for the discussion in the United States are more than 120 people in Germany, these cases are governed by the Federal Institute for Drugs and Medical Devices (BfArM), they are not known.