Oral films may be easier way to deliver pramipexole

Placing medicated film in the cheek may appeal to patients who have difficulty swallowing

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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An illustration shows a plethora of pills and capsules in a variety of sizes.

Researchers have created a novel formulation of pramipexole — the active agent in Mirapex — that can be administered via a film placed on the inside of the cheek.

The new formulation may make treatment easier for people with Parkinson’s disease who have trouble swallowing, scientists said in the study “Formulation and characterization of pramipexole containing buccal films for using in Parkinson’s disease,” which was published in the European Journal of Pharmaceutical Sciences.

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Parkinson’s is characterized by the death and dysfunction of brain cells responsible for making the chemical messenger dopamine. Pramipexole is a dopamine agonist — a molecule that mimics the activity of dopamine in the brain.

Mirapex, a tablet form of pramipexole taken orally, is approved to treat motor symptoms of Parkinson’s. It’s sold by Boehringer Ingelheim, which was not involved in this study.

Many people with Parkinson’s experience trouble swallowing, which may make it harder to take oral medicines like Mirapex. One alternative to oral therapies are buccal films — strips that are placed on the inside of the cheek, and release a medication through the mucus-covered lining of the cheeks (called the buccal mucosa) into the bloodstream.

A team of scientists in Hungary synthesized polymer-based buccal films to administer pramipexole, with the long-term goal of making the therapy more easily usable by people who have swallowing problems.

“One of the major difficulties in the treatment of Parkinson’s disease is the difficulty in swallowing for the patients.  The buccal mucoadhesive films produced in our work can solve this problem because the patients do not have to swallow the dosage form, and during application, pramipexole can be absorbed from the area of the buccal mucosa quickly without causing a foreign body sensation,” the researchers wrote.

Several versions of the pramipexole films

The scientists created several versions of the films, then conducted a series of tests to examine their characteristics. This included assessing the thickness and hardness of the films, as well as testing how well they could stick to mucus-covered surfaces like those on the inner cheek, and measuring how quickly the medication was released. The team also tested the biocompatibility of the films, with experiments done in lab dishes to test whether the films had any toxic effects on cheek cells.

From all these experiments, the researchers identified two formulations — which they referred to as “Sample 1” and “Sample 4” — that hold the best properties for potential use in patients. Data suggested these formulations could release more than 70% of their pramipexole load in about five minutes, and they did not have any notable toxic effects on cells.

The team noted that additional preclinical study will be needed before these new formulations can be tested in people.