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Gel formulations for oral administration of drugs, in particular to dysphagic patients
UniCam – Technology transfer research and project management area
Formulation that can be used for hydration and therapy administration in patients with swallowing disorders.
Field of application
The object of the present invention is to develop an effective method for reformulating conventional release commercial tablets containing water-soluble active ingredients in a semi-solid preparation (hydrogel) for oral administration, to facilitate drug intake in dysphagic patients. Since most of the drugs are only available on the market in tablet form, the gelled preparation offers an effective therapeutic alternative to patients with swallowing difficulties. The invention may have potential applicability if a hospital pharmacy has an interest in standardizing and optimizing galenic preparations of active ingredients available only as tablets for therapy in dysphagic patients. Large-scale marketing can help improve treatment options for patients who experience swallowing inability during their lifetime. Industrial production will occupy a market share, which is currently not covered.
Advantages
The main advantage is that of being able to administer to patients with swallowing difficulties active ingredients present on the market only as solid oral pharmaceutical forms (capsules, tablets) without modifying the drug release kinetics while modifying the pharmaceutical form. Furthermore, this process will ensure the preparation of products in a standardized and controlled manner.
INVENTORS: Giulia Bonacucina, Marco Cespi, Luca Casettari, Elisabetta Torregiani, Giovanni Filippo Palmieri, Diego Romano Perinelli, Roberta Ganzetti, Matteo Sestili.
The research group is coordinated by Prof. Giulia Bonacucina della School of Pharmaceutical Sciences and Health Products
The video of presentation.
Pharmaceutical Technology Research Group
The Pharmaceutical Technology research group, which includes Prof. Giulia Bonacucina, deals with the formulation and characterization of traditional pharmaceutical forms. Solid dosage forms for oral administration. At the same time it is also involved in the development of innovative pharmaceutical forms that employ advanced carrier systems. Of micellar systems, thermogelling agents, micro-nanoemulsions and liposomes able to increase the therapeutic efficacy and reduce the side effects of different types of active compounds. The chemical-physical characterization of these systems makes use of the aid of various analysis techniques such as rheology, thermal analysis, acoustic spectroscopy, tensiometry, fluorimetry. There are also various collaborations with industries in the pharmaceutical sector (Angelini, Chiesi, Janssen-Pharmaceutical Company of Johnson & Jonhson, Alfa Wassermann, Aboca)
For some years, thanks to the collaboration with professionals in the health sector, the research group has been dealing with the issue of reformulation of drugs intended for dysphagic patients. These studies have led to obtaining the Italian patent RBI14891-IT “Gel formulations for oral administration of drugs in dysphagic patients”.
Source: The newspaper of Piceno and Marche
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Note:
The gel allows to obtain an unaltered release kinetic of the active principle, compared to that of the active principle formulated in the original solid form. The present patent therefore describes the dispersion of an immediate release tablet or capsule containing a water-soluble active ingredient in a formulation semi-solid with rheological characteristics comparable to commercially available gelled drinks, used for hydration and administration of therapy to patients with swallowing disorders.
POSSIBLE APPLICATIONS
- Potential applicability within hospital pharmacies to standardize, optimize and automate galenical preparations of drugs available only as tablets;
- Large-scale marketing can improve therapeutic possibilities for dysphagic patients;
- Industrial production can cover a market share, which is currently entrusted to the galenic production in a pharmacy.
ADVANTAGES
- Avoid any manipulation operation by eliminating the dangers related to loss of active principle;
- Avoid, contamination and dosing errors with greater safety in the administration of drugs;
- The active ingredient is found in a dosage form with a consistency suitable for swallowing in the dysphagic subject. without its release kinetics being altered.
Editor's note: Dysphagia consists of the objective difficulty in swallowing solid or liquid foods, or the sensation that the ingested food remains halfway between the mouth and the stomach. It is very similar to odynophagia in which swallowing causes a painful sensation caused by the passage of food (especially hot, alcoholic or spicy liquids) on the inflamed esophageal mucosa. One major exception to the customary pattern of dysphagia is achalasia characterized by a tendency for more difficulty swallowing fluids than solids. THE chewing disorders it is estimated that they concern approx the 8% of the world population and the percentage rises to11-16% in the elderly. There administration of oral therapy becomes an extremely complex care process in patients who present difficulty in swallowing. Furthermore, many drugs cannot be crushed to make them easier to take. Dysphagia can have a different level of severity (very mild, mild, medium, severe) which require specific nutritional attention.
Related news: Administration of oral therapy to the dysphagic patient