Technology

Buccal and oral films   – because what’s simple is also fast

  • Films are especially useful when two or three of the following factors are present:
  • Patients who do not want to or are unable to take tablets or oral solutions. These may be very young children, the elderly, individuals with behavioural issues or those with a mental or physical disability.
  • Situations that demand simplicity, speed and, not least, having the product at hand when you need it! Taking a tablet as advised requires a glass of water, which is not necessary with films.
  • Pharmaceutical substances with the right pharmacokinetics and pharmacodynamics so that the film provides the right conditions for the substance, and vice versa. In addition, it must be possible to manufacture the film and that the product has good storage stability. This is precisely the kind of cutting-edge knowledge that SWIPP and its GMP partner AdhexPharma possess.

Buccal films are applied to the oral mucosa, i.e. the inside of the cheeks or the lips. 

applicering av filmen som en oral film
Oral films are placed on the tongue, either by the patient or someone helping the patient.

How films work
Films can be used by the patient themselves or by someone helping the patient. SWIPP uses two forms of film technology: buccal films and oral films.

Buccal films
Buccal films are applied to the oral mucosa, the inside of the cheeks. The medicine is absorbed through the mucosa (so-called transmucosal absorption) and passes directly into the bloodstream. This method avoids what is known as the first pass effect, which affects numerous pharmaceutical substances, reducing or slowing their uptake. Not all pharmaceutical substances are suitable for delivery through transmucosal absorption. Midazolam is suitable, however.

Oral films (ODF)
Oral films are also called orodispersible films (ODFs). These are placed on the tongue where the film dissolves rapidly and the substance is carried down to the stomach by the normal flow of saliva, which can be as much as 1 mL per minute. The substance is then absorbed in the stomach in the same way as if delivered by a tablet. There is no absorption through the oral mucous membranes with oral films, but they are easier to administer than a tablet. Simple is fast, plain and simple. Because, if we include the time it takes to locate the tablets and fetch a glass of water – or buy a bottle of water, the film always wins that race. 

Patents

SWIPP constantly evaluates the potential to apply for patents for inventions resulting from the product development. These may relate to compositions, manufacturing methods or methods of use. Sometimes a co-inventor from outside SWIPP may be involved (e.g. from our development and GMP partners), but the rights are always carefully assigned through written agreements.
  • At present, SWIPP has two patent families:
  • WO 2017/009446 A1 with priority date 15 July 2016
  • PCT application with filing date 25 Aug 2022 and claiming priority from 25 Aug 2021

Unique expertise cannot be copied
Patents are not the only method used to protect property resulting from SWIPP’s product development work. Some elements are best protected by the data or know-how being kept confidential. Upon subsequent product approval, e.g. in the EU or the US, the products are enjoy some regulatory data protection. This means that should a competitor want to attempt to copy SWIPP’s work, they too must go through the entire development process and carry out all necessary studies themselves. Competitors are thus not allowed to apply for product approval solely by referencing to SWIPP’s approval. They too must prove that their product works. By themselves and by conducting their own studies.