Rizatriptan ODS and its affect on Migraine

January 5, 2022 Spread the awareness:

Even after years of research, Migraine remains to be an incurable disorder – no treatment can make patients free of migraine permanently.

People suffering from migraines can keep their condition in control by avoiding triggers that cause migraine. Identifying these triggers and working towards making little changes in lifestyle like easing stress and having good sleep habits can help curb the symptoms.

Prompt action and timely treatment help patients return to their normal routine, decreasing the need for pain medication.

Having said that, there are medications that help prevent or stop migraines, keeping the symptoms from getting worse. Rizatriptan is one such medication.

What is Rizatriptan?

Rizatriptan is a medication that’s used to treat migraines. It belongs to a class of drugs known as triptans and helps relieve headache, pain, and other migraine symptoms caused due to nausea, vomiting, and sensitivity to light/sound.

It affects a certain natural substance (serotonin) that causes the narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain.

Understanding Migraine & its effects on the brain

Migraine is a chronic neurological disorder characterized by recurrent headaches that range from moderate to severe, often in association with a number of autonomic nervous system symptoms.

Approximately 15% of the world population is affected by migraine at some point in life.  In basilar migraine, a patient will experience neurological symptoms related to the brain stem or with neurological symptoms on both sides of the body. Some common effects of this migraine include a sense of the world spinning, light-headedness, and confusion. Nausea occurs in almost 90% of people, and vomiting occurs in about one-third.

Other symptoms may include blurred vision, nasal stuffiness, diarrhea, frequent urination, pallor, or sweating. Moreover, swelling or tenderness of the scalp may occur as well as neck stiffness. Oftentimes, a feeling of pins-and-needles begins on one side in the hand and arm and spreads to the nose-mouth area on the same side. Numbness usually occurs after the tingling has passed, with a loss of position sense.

As Rizatriptan is an Oral Thin Film (also called Orally Dissolving Film), it becomes extremely convenient for the patient to take the required prescribed dosage even when suffering from such severe symptoms. It’s also very easy to carry and needs no water, unlike solid oral dosage – a patient can put this film in their mouth anywhere, anytime they face the symptoms and it instantly dissolves to start the action.

What are Oral Thin Films?

With the recent developments in research and technology, more viable oral dosage forms have been introduced, especially to assist in medication adherence in pediatrics, geriatric, bedridden, nauseous, or non-compliant patients. Various bioadhesive mucosal dosage forms have been developed, including adhesive tablets, gels, ointments, patches, and more recently –  Oral Thin Films (OTFs). Oral thin film is categorized into Mouth Dissolving Film/Fast Disintegrating Film, Buccal Film, and Sublingual Film.

The mouth dissolving film is also known as fast dissolving film, quick-dissolving film, and rapid dissolving film.

It consists of a fast-dissolving polymeric film embedded with a drug that quickly hydrates and disintegrates when placed on the tongue to provide rapid local or systemic drug delivery without the need for water.

Fast Disintegrating Film dissolves or disintegrates quickly in the oral cavity, resulting in the solution or suspension without the need for water – in a matter of seconds.

In contrast to other existing, rapid dissolving dosage forms (which consist of lyophilized products), the rapid films can be produced with a manufacturing process that is competitive with the manufacturing costs of conventional tablets. 

Why Oral Thin Films?

Oral thin film disintegrates fast in the mouth and assures accurate dosing in a safe, efficacious format that is convenient and portable, without the need for water or dosage measuring. In addition, the oral thin film permits intra-oral absorption, thus bypassing first-pass effects in some cases.

Rizatriptan vs Sumatriptan

Rizatriptan and sumatriptan are selective 5-HT(1B/1D) receptor agonists for the acute treatment of migraine. For oral formulations, the time to maximum plasma concentration is reached earlier with Rizatriptan than with Sumatriptan (1 h versus 2-2.5 h) and Rizatriptan has greater bioavailability than Sumatriptan (45% versus 15%).

These pharmacological advantages translate into a faster onset of action and a better overall response for oral Rizatriptan versus oral Sumatriptan. The two drugs have been directly compared in randomized, double-blind, placebo-controlled clinical trials with patients suffering from moderate to severe migraine attacks.

Rizatriptan 10 mg was generally superior to Sumatriptan on a measure of time-to-pain-relief within 2h where pain relief was defined as a reduction of pain to mild or none (odds ratio for Rizatriptan versus Sumatriptan 100 mg = 1.21; odds ratios for Rizatriptan 10 mg versus Sumatriptan 50 mg = 1.14 and 1.10 in two studies).

International Headache Society recommended endpoint of the percentage of patients pain-free at 2 h (40% for Rizatriptan 10 mg, 33% for Sumatriptan 100 mg, and 35% for Sumatriptan 50 mg). Further advantages for Rizatriptan were seen on stringent outcome measures of the percentage of patients who were completely free of all symptoms at 2 h, patient satisfaction with medication at 2 h, and 24-h sustained pain-free response.

About ZIM Laboratories

ZIM Labs is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for the production and supply of innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs we provide our customers a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellets (sustained, modified, extended-release), taste-masked powders, suspensions, tablets, capsules, and recently developed Oral Thin Films (OTF).

 

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