Trofentyl OTFC lollypops with fentanyl painkiller in India

Trofentyl OTFC lollypop with Fentanyl pain reliever, painkiller lozenge opiod formulation from Troikka Pharmaceuticals India.

Trofentyl OTFC, a lozenge for severe, uncontrolled pain has been launched in India by Troikka Pharmaceuticals.

Trofentyl OTFC lozenges come in the convenient form of a `lolly-pop’’ allows the pain killer to get absorbed through the mouth, thus sparing the already strained cancer patients of painful injections to relieve pain bouts.

Trofentyl OTFC (oral transmucosal fentanyl citrate) contains  200 mcg of fentanyl,  a  few opioid formulation. Lozenge, containing the active drug is mounted on a lozenge holder stick. The patient can suck the lozenge pill in mouth like a lollypop, holding it with the lozenge holder, and get the pain relieved.

Trofentyl lozenge is pleasantly tasting too. It does leave the usual bitter aftertaste, once you relish the tablet. Appropriate taste masking technology is used to ensure that the lozenge has a pleasant taste.

Also, if the patient feels any discomfort while taking the drug, the drug lozenge can immediately withdrawn from the mouth. This is a unique advantage compared to the conventional pills and injections, which once administered cannot be withdrawn till it run full course in the body even if the patient experience any discomforts  due to some undesired effects.

Trofentyl OTFC is a new opioid formulation. Trofentyl OTFC starts acting immediately as it has a rapid onset of action & a short duration of effect. These characteristics, which resemble the course of a typical breakthrough pain episode, resulted in making OTFC the first opioid analgesic formulation specifically developed & approved for control of breakthrough pain in cancer patients, a Troika release said.

Trofentyl OTFC is indicated only for the breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to opioid therapy for their persistent cancer pain.

“Terminally ill cancer patients are administered analgesics to provide a blanket of pain relief. However, more than once in 24 hours, the pain breaks through the protective blanket of analgesics, causing severe agony to the patient. This bout of severe pain usually lasts for 30-60 minutes and thereafter subsides. But it wears out the ailing patient and diminishes the quality of life. Trofentyl OTFC medicated lozenge promptly aborts the bout of breakthrough pain and significantly improves quality of life of cancer patients,” Ketan Patel, Managing Director, Troikaa Pharmaceuticals said.

The lozenges and the holder are indigenously designed and patented.

The buccal (mouth) region offers an attractive route of administration for delivery of drugs that undergo rapid enzymatic degradation within the gut or break down into inactive components in the liver after being swallowed. The challenge is to ensure absorption of the drug through the oral mucosa, the membrane lining our oral cavity.

Fentanyl is an odourless, rapid-acting opioid  which depresses central nervous system and respiratory function. It is the most powerful opioid known, with a potency approximately 80 times that of Morphine and 100 times that of Heroin. Fentanyl has an LD50 of 3.1 milligrams per kilogram in rats and 0.03 milligrams per kilogram in monkeys. Several analogues of fentanyl are available, and each differ in terms of potency. Additionally, Fentanyl is classified as a Schedule II drug in the United States due to its high abuse rate.

Fentanyl’s major side effects (more than 10% of patients) include diarrhea, nausea, constipation, dry mouth, somnolence, confusion, asthenia (weakness), and sweating and, less frequently (3 to 10% of patients), abdominal pain, headache, fatigue, anorexia and weight loss, dizziness, nervousness, hallucinations, anxiety, depression, flu-like symptoms, dyspepsia (indigestion), dyspnea (shortness of breath), hypoventilation, apnea, and urinary retention. Fentanyl use has also been associated with aphasia.

Intravenous fentanyl is extensively used for anesthesia and analgesia, most often in the operating room and intensive care unit. It is often administered in combination with a benzodiazepine, such as midazolam, to produce procedural sedation for endoscopy, cardiac catheterization, oral surgery, etc.

Fentanyl is often used in cancer therapy and other chronic pain management due to its effectiveness in relieving pain. There is no known opioid stronger than Fentanyl in reducing cancer pain, which makes it the first choice for use in cancer patients.

Started in 1984, Troikaa Pharmaceuticals is based in Ahmedabad. The company holds patented technology platforms for various Novel Drug Delivery Systems – intra-oral, oral, parenteral, sustain release & topical. Troikaa has two manufacturing facilities located in Ahmedabad and Dehradun (Uttaranchal). The Ahmedabad facility located at Thol; an industrial area which is 25 Kilometers from Ahmedabad has capability to manufacture high quality Critical Care Injectables, Tablets and Topical preparations.

Troikaa’s state-of-the-art manufacturing facilities are certified by the World Health Organization for following Good Manufacturing Practices and its Quality Management Systems certified by KVQA to follow ISO 9001:2000 standards for manufacturing and supply of Drugs and Pharmaceuticals.