Our inhalation products R&D studies have begun with dry powder inhaler blister type devices. First of all, our purpose was to create a unique dry powder inhalation tool for our company. The device, which does not violate specific drug patents in the world and whose nature allows the dry powder to be inhaled at varying flow rates, was developed and patent applications were initiated and some of them patented. Following international standards and guidelines, our formulation and analytical tests are performed by an established R&D team. Intellectual property rights studies were conducted cooperatively with our department of intellectual property rights. Production, filling, and packaging equipment developed especially for inhalation drugs was used in formulation studies. The device analyses and empirical studies are performed in compliance with the guidelines of the EMA and FDA, and consultancies were obtained in this respect.
In addition to dry powder inhalation products, we intend to invest in the required equipment to perform research and development studies on the various forms of inhalation devices. Specific innovative research and engineering projects are also underway while taking into consideration various markets. Furthermore, research has been carried out for the licensing of products, especially in the FDA, Europe, and other countries.
“Cyplos Sanohaler 50/100 mcg, 50/250 mcg and 50/500 mcg Powder for Inhalation” products of 60 dosages, “Tutast Sanohaler 18 mcg” are 30-dosage blister type dry powder inhaler products. These products have been started to develop by Sanovel Pharmaceutical Ind. and Trade Inc. within the body of Toksöz Group in 2006 and the first domestic dry powder inhalation products which were produced in Turkey, placed on the market in 2012. Production of inhalation products has been carried out by Arven Pharmaceutical Industry and Trade Inc. within the body of Toksöz Group continues at the factory in Kırklareli Organized Industrial Zone since 2017.
The first goal in the product development process was to create an inhalation system that would provide the same performance in-vitro / in-vivo as the reference devices on the market, which would provide the consumer with ease of use. The device’s design and production activities move in this direction, and consultations received from many companies abroad, however, it has been completely implemented in Turkey. The key features that differentiate our medical device from the others are the measurement of the dose numbers with the numbers on the blister strip not by a different counter and preventing misusing of the doses with the control mechanism and valve system. Our technology does not infringe patents on similar medical devices presently on the market but is protected in many European and US countries by several patents.
Especially in the selection of materials to be used in the production of device parts, medical-grade materials are preferred. The production and assembling of medical devices are carried out entirely in Turkey, and equipment and machinery are used exclusively for this product. Blister strips comprising the powder in the medical device delivered to the patient are manufactured in our facility and both active and excipient substances used are chosen from specific materials designed for inhalation devices. All equipment used in the powder filling and assembly phases is designed specifically for our product and imported from abroad. In a controlled area (Class D) for inhaler products, all production, filling, and assembling stages are conducted in the GMP field. Each of our production, filling and assembly stages realized with high technology and monitored by intensive quality control studies.
Our first goal from now on is to serve Cyplos Sanohaler 50/100 mcg, 50/250 mcg, and 50/500 mcg Powder for Inhalation products to overseas markets which are produced entirely with domestic capital and high technology. Another goal is to develop different molecules and medical devices and make them available to patients.