We Obtained The First Local Morphine Tablet License

What is Morphine?
Morphine is a very well-known opioid derivative with pharmacokinetic and pharmacodynamic properties that is used in oral, intravenous, intramuscular and subcutaneous ways in palliative treatment of medium and strong cancer pains. 

What is the importance of morphine in the palliative treatment of cancer? 
According to the result of the statistical assessment conducted by the World Health Organization on 12 December 2012, there are 14.1 million adult cancer patients in the world, and 8.2 million deaths occur due to cancer. According to the estimated data, the number of cancer cases in 2025 will reach 19.3 million. This shows that the pain caused by cancer and cancer treatment will increase.

The assessment of cancer cases in the world show that based on the increasing pain as the cancer progresses, one of each 3 cancer patients suffers from mild or sever cancer pain. 30% of cancer patients suffer from pain during the diagnosis period and 65-80% during the progression of the cancer, and cancer pain becomes stronger together with pain interaction and the general symptoms of cancer such as fatigue, weakness, nausea and constipation. 

Cancer pain may be treated effectively on 85-95% of the patients who suffer from cancer pain as a result of programming systemic, pharmacologic and anticancer treatments as depended to each other.

On the cases with chronically strong cancer pain, oral application of morphine is the most commonly used and most effective treatment option. As a result of the data obtained from 62 studies carried out with 4241 participants; it was found that oral morphine use is effective in the treatment of cancer pain.  

In the global pharmaceutical market, there are morphine preparations with different dose forms and different release mechanisms, and morphine is released with different speeds from these dosage forms. Its conventional form is immediately absorbed, and in order to ensure the optimum effect, it must be implemented regularly once every four hours. 

The tablet form, which provides a controlled release, releases slower and controlled morphine than the conventional morphine tablet; therefore, its administrating every 12 hours will be effective. The form with controlled release increases the effectiveness of treatment, the compliance of the patient and the acceptability of the treatment. 

In addition to adult cancer patients, the morphine tablets provide controlled release in the treatment of medium and severe pain in children suffering from sickle-cell disease, and in addition to being an alternative treatment option to the intravenous application of morphine, they also increase the patient's compliance as a result of a lower frequency of dosing.

What is the situation in Turkey on morphine use?
In Turkey, there are not any oral morphine preparations for the palliative treatment of cancer, and there are serious bottlenecks in their supply. 

Therefore, the Ministry of Health of Turkey started the 5-year long cancer control program in 2009, and the project Pallia-Turk was completed in 2011. The 4 headings in this project are as follows;
1) Increase availability of morphine in the market,
2) Issue a new law related with morphine formula,
3) Train medical personnel against opiophobia,
4) Implement a palliative maintenance model issued under the supervision of the family physician.

How did the work related with the production of domestic morphine start?
As a part of the Pallia-Turk program upon the proposal of Hacettepe University Rectorate and with the undersigned protocol, the activities towards morphine sulfate tablet projects that ensure immediate release and controlled release started in May 2013 at ILKO Research and Development Center, and all studies of the project were carried out under the body of ILKO Research and Development Center and İLKO Pharmaceuticals.

The purpose of developing these tablets is to offer conventional release tablets with 15 and 30 mg doses for short term pain treatment, and controlled release tablets with 15, 30, 60 and 100 mg doses for long term pain treatment. 

The project to develop and produce Morphine tablets that have not been produced in our country so far was conducted by İLKO Pharmaceuticals with a social responsibility and service approach.

The applicability of the morphine sulfate raw material supplied from the Turkish Grain Board (Toprak Mahsulleri Ofisi) for use in research & development and pilot production works was tested with the methods developed by İLKO Argem, and they were found to be eligible and suitable for use in pharmaceutical production in accordance with the standards in the American and European Pharmacopeia.

For the products for which thebioequivalence studies were carried out in Germany, a license application was made to the Turkish Pharmaceutical and Medical Device Organization, and licenses for morphine tablet products with immediate release under the commercial names Morfia 30 mg Tablet and Morfia 15 mg Tablet were obtained on 16 December 2014. License works of Morfia 100 mg CR Film Tablet, Morfia 60 mg CR Film Tablet, Morfia 30 mg CR Film Tablet and Morfia 15 mg CR Film Tablet are ongoing.

What kind of benefits will the production of morphine in Turkey have?
So far, painkillers imported from abroad were used in our country instead of morphine. From now on, the conventional and controlled release tablets of Morphine Sulfate, which are primarily used in the palliative treatment of cancer, will be offered in Turkey. As a result of the production of morphine in Turkey, patients who are required to use morphine sulfate, or who must use morphine sulfate, will be able to access morphine tablet faster and at a low cost. Furthermore, our country's dependence on outside will decrease and a great contribution will be provided to the Turkish Pharmaceutical Industry and the Turkish economy.

ACKNOWLEDGEMENT:
The knowledge and experience of our ILKO Research and Development Center have been the most important sources of success in the technological completion of this project.

With this opportunity, we express our gratitude mainly to our R&D and Licensing Director Prof. Yılmaz Çapan, and the entire İLKO ARGEM and İLKO team who have contributed to the Morphine Tablet project.

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