Our Technology

The oral mucosa is the highly absorptive lining of the mouth. It is richly supplied with blood vessels and the mucosal membrane is relatively permeable. As a result, contact with these surfaces enables rapid drug absorption into the systemic circulation. The formulations reach the systemic circulation through different sites within the oral mucosal cavity.

SUDA’s proprietary OroMist® oro-mucosal technology can deliver a broad range of drug classes through either the cheeks, gums, tongue or floor of the mouth. The technology is compatible with, and patented for, use in either pump (air-activated) or aerosol (propellant-driven) spray systems, and can be provided in either multi-dose or unit containers based on the medical need and marketing requirements for each product.

The technology and delivery route can provide meaningful benefits compared to other modes of drug administration, including:

  • provide faster onset of action;
  • reduce the dose level;
  • increase bioavailability of the drug by avoiding first pass metabolism in the liver
  • minimise dose variation related to gastrointestinal tract motility;
  • enhance patient compliance and convenience;
  • avoid the need to swallow, which is a problem for many people;
  • allow for the medication to be taken without water;
  • facilitate self-medication; and
  • decrease the need of medical personnel.

 

Drug delivery via the oral mucosa can minimise dose variation related to gastrointestinal tract motility, stomach emptying time, food effects, tablet/capsule disintegration and dissolution and enzymatic or chemical degradation in the gut. Due to decreased degradation and higher absorption, oral sprays often permit the use of a lower dose of the active ingredient compared with tablet formulations of the same drug, potentially reducing the risk of adverse drug reactions.

In many cases, including treatments for patients with difficulty swallowing or nausea, oral spray administration provides enhanced convenience resulting in greater compliance. In fact, swallowing problems (known as dysphagia) are extremely common with an estimated prevalence as high as 22% in those over 50 years of age. Approximately, 10 million Americans are evaluated each year with swallowing difficulties. Furthermore, many children have difficultly swallowing tablets without water.

 

OROMIST® TECHNOLOGY

Bioavailability is the primary challenge for SUDA’s OroMist® sprays. Our suite of technologies addresses bioavailability by a combination of proven proprietary and known technologies to optimise and measure solubility, permeability and palatability. Formulations are developed in a logical fashion beginning with simple FDA approved excipients and building to complex solubilisation and or permeability enhancers only as required.

With the OroMist® technology, SUDA uses a combination of proprietary co-solvents, plus pH and/or electrolyte addition via specific salts or mixes of excipients for ionisable compounds is used to solubilise sufficient drug in the correct stable form to provide efficient permeation through the buccal mucosa. Lipids and eutectic lipid mixtures may be used to provide solubility and aid permeation for more lipophilic compounds. SUDA has also developed a proprietary permeation-enhancing technology with broad applications based on the use of novel combinations of hydrotropes.

SUDA has an extensive knowledge of proven techniques to improve solubility including particle size reduction and solid dispersions, complexation with materials such as cyclodextrins and micellar dispersion in emulsions, which may be utilised if required.

Permeability enhancers may be required to improve bioavailability and SUDA employs a logical succession of simple to complex systems to aid buccal permeation.

Many drugs are very bitter and must be taste masked and flavoured for patient compliance in such a way that solubility and permeation are enhanced or at least maintained. SUDA’s use of specific flavour/sweetener/ taste mask combinations ensures that the formulation is palatable to the user whilst maintaining bioavailability.

Iterations of formulations are assessed for physical and chemical stability, for in-vitro and ex-vivo permeability and for palatability to ensure that formulations that make it through to in-vivo PK and toxicological studies have been thoroughly characterised and have the highest chance of success.

OroMist® key points:

  • Proven - Three prescription oro-mucosal spray drugs utilising OroMist® technology approved in the USA: Two for human health: NitroMist® (nitroglycerin lingual aerosol - Akrimax Pharmaceuticals,LLC) and ZolpiMist (zolpidem tartrate -Amherst Pharmaceuticals/SUDA Ltd); and one for companion animal health: OroCAM®/RevitaCAM® (meloxicam) - Abbott Animal Health
  • Versatile - The technology can be moulded according to the formulation’s needs
  • Patentable – The patent protection can be stratified and increased over time depending on the adjustments that can be introduced
  • Extensive know-how – Experienced lab team able to assess and test
  • Committed to design and deliver medical treatments with a patient in mind

 

Intellectual Property

SUDA's intellectual property includes granted and pending patents, trademarks and proprietary know-how. The patent estate covers the hydrotrope permeation-enhancing technology and liquid spray formulations of over 300 Active Pharmaceutical Ingredients (APIs) from a wide range of drug classes such as anti-infectives, (i.e. antibiotics and antifungals), anti-asthmatics, barbiturates, opioids as well as biologically active peptides hormones such as, insulin and cyclosporine. These formulations can be administered to the oral cavity in the form of a micro-mist that covers the oral mucosal membranes. The management intends to strengthen the intellectual property portfolio as it progresses with its R&D efforts.