Hananja

Our intranasal technology

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Our core technology is to transport substances across biological membranes within minutes, achieving rapid onset of action. We have also developed technologies to bring biologically active substances to different regions, such as directly into the brain (bypassing the blood-brain barrier) or into the lymphoid tissue. In both cases, intranasal administration was used.

 

Approved excipients for intranasal delivery

For the past three decades, researchers all over the world have searched for new excipients to improve existing formulations, to provide line-extension and to deliver difficult substances into the systemic circulation. Although numerous excipients have entered phase I clinical trials only few have reached phase II and it is very rear to hear about excipients that have reached  phase III clinical trials. Hananja’s excipients, mPEG, are one of these rare ones. Today, this excipient is only licensed for benzodiazepines – all other options are available.

 

An intranasal delivery system

The need for well-designed drug delivery systems is endless. Although, discoveries of new molecules are important, the demand for new effective and safe delivery systems is also increasing. Numerous excipients have been found capable of promoting the flux of drug across the nasal membrane, but almost non have reached phase II or phase III clinical trials. Our intranasal technology and proprietary excipients has unique capabilities:

Solubility: The ability to solubilize one clinical dose in less than 100μL (200 μL if we use both nostrils) is not an easy task. This is usually the major bottleneck for a number of therapeutic agents. Example: The solubility of midazolam is less than 0.1 mg/mL or less than 10 μg/100 μL. By adding certain excipients into the formulation a nasal product may be made with a 500-1000 x increased solubility, reaching 5-7.5 mg of the drug per nostril.

Absorption capacity and absorption rate: How much drug may be transported into the systemic circulation within 20-30 minutes? Drugs usually stay no more than that inside the nose, before it is cleared down to the pharynx and swallowed. Example: when the commercially available sumatriptan (Imigranâ: 20 mg/dose) is delivered into the nose, no more than about 0.25 mg is absorbed within the first 10 minutes. However, by adding certain excipients into the formulation the absorption capacity and absorption rate may be improved 80 fold, within the first 10 minutes.

Molecular size limit:The nasal mucosa provides a perfect barrier to molecules, peptides and proteins, where the largest threshold is for molecules with molecular weight above 1 kD. Hananja’s excipients are able to improve the absorption of large molecules without harming the nasal mucosa.

 

The duration inside the nasal mucosa: After administration, the half-life inside the nasal cavity is about 15-20 minutes controlled by the ciliary clearance mechanism and the secretion of mucins. Affecting the clearance time can double or triple the bioavailability, depending on the mechanisms used to increase the duration inside the cavity.

 

 METHOXY-POLYETHYLENEGLYCOLE (MPEG)

 We discovered the excipient mPEG in 2006 and filed our patent in 2007. This mPEG displays most of the criteria we were looking for. Today, the proof of concept, toxicological evaluation as well as other regulatory work has carried out and the mPEG is now in phase III clinical trials.

 

 

 

 

 
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Hananja plc

  • Address: Aflagrandi 7
  • City: 107 Reykjavík, Iceland
  • Tel: (+354) 898-0318
  • Email: sg@hananja.com