Inhaled preparations refer to liquid or solid preparations in which the raw drug is dissolved or dispersed in a suitable medium and delivered to the lungs in the form of aerosols or vapors to exert local or systemic effects. According to the type of preparation, inhalation preparations mainly include inhalation aerosols, inhalation powder aerosols, inhalation sprays, inhalation liquid preparations and transformable vapor preparations. According to the route of administration, it can be divided into oral inhalation preparations and nasal inhalation preparations.
In this issue, the Apex product team brings you two cases of new nasal spray preparations to share.
01
Advantages of nasal spray preparations
In recent years, as a new method of drug delivery, nasal spray has received more and more attention in the field of innovative drugs and improvement. The advantages of nasal spray are mainly reflected in:
Rapid drug action: Compared with the traditional oral and injection drug delivery routes, the active substance of the nasal spray can be absorbed directly through the nose very quickly, enter the blood circulation or directly act on the local nasal cavity, so as to achieve rapid effect.
② Avoid liver first pass effect: through nasal injection, the drug can bypass the digestive process of the gastrointestinal tract and directly enter the blood circulation, thereby avoiding the liver first pass effect, reducing the metabolic loss of the drug in the liver, and improving the bioavailability of the drug.
③ Improve patient acceptance and compliance: nasal spray administration is non-invasive, easier and more comfortable than injection administration, and there is no need to go to medical institutions regularly, improving patient compliance.
It can be used for the treatment of central nervous system diseases: nasal spray has a high bioavailability to the central nervous system, which can overcome the limitations of the blood-brain barrier and achieve effective treatment of brain and central nervous system diseases.
⑤ Diversified indications: nasal injection is not only suitable for the treatment of local diseases of the nasal cavity, such as allergic rhinitis, nasal congestion, etc., but also can be extended to the field of systemic treatment, such as migraine, osteoporosis, nausea, depression, epilepsy and other central nervous system diseases.
02 -- Case Study
Sumatriptan nasal Spray (Tosymra)
As a revolutionary drug in the treatment of migraine, triptans can selectively activate the 5HT1B/1D receptor, which can act as a treatment for migraine through a variety of pathways.
Traditionally, Sumatriptan is administered orally or intravenously. However, oral administration often takes more than 2 hours to take effect, and patients who experience nausea and vomiting may have difficulty tolerating oral formulations.
Although intravenous administration can be effective within 10 minutes, it requires professional medical equipment and personnel to operate, which is not only complicated, but also limits the freedom of movement of patients.
In contrast, Sumatriptan nasal spray (Tosymra) is administered intranasally and can be administered by the patient without the assistance of a medical professional, greatly increasing the convenience of medication. In terms of onset time, Sumatriptan nasal spray can significantly reduce headache within 15 minutes, and more than 70% of patients can return to normal life and work after 2 hours, which is comparable to intravenous administration.
In 2019, the US FDA officially approved Tosymra (Sumatriptan nasal spray, 10mg) for the continued treatment of adult migraine (with or without aura). To provide a new treatment option for migraine patients in the region.
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Prescription information for Tosymra (Sumatriptan nasal spray, 10mg) is as follows:
Every 100 ul of TOSYMRA contains 10 mg of a single dose of sumatriptan in aqueous solution containing citric acid monohydrate, N-dodecyl β-D-maltoside, potassium dihydrogen phosphate, sodium chloride, and anhydrous d...
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