ABSTRACT
PURPOSE: Bioadhesion is an important property of biological membranes, that can be utilized in pharmaceutical and biomedical applications. In this study, we have fabricated mucoadhesive drug releasing films with bio-based, non-toxic and biodegradable polymers that do not require chemical modifications. METHODS: Nanofibrillar cellulose and anionic type nanofibrillar cellulose were used as film forming materials with known mucoadhesive components mucin, pectin and chitosan as functional bioadhesion enhancers. Different polymer combinations were investigated to study the adhesiveness, solid state characteristics, film morphology, swelling, mechanical properties, drug release with the model compound metronidazole and in vitro cytotoxicity using TR146 cells to model buccal epithelium. RESULTS: SEM revealed lamellar structures within the films, which had a thickness ranging 40-240 µm depending on the film polymer composition. All bioadhesive components were non-toxic and showed high adhesiveness. Rapid drug release was observed, as 60-80% of the total amount of metronidazole was released in 30 min depending on the film formulation. CONCLUSIONS: The liquid molding used was a straightforward and simple method to produce drug releasing highly mucoadhesive films, which could be utilized in treating local oral diseases, such as periodontitis. All materials used were natural biodegradable polymers from renewable sources, which are generally regarded as safe.
Subject(s)
Adhesives/metabolism , Cellulose/metabolism , Drug Carriers/metabolism , Mucins/metabolism , Nanofibers , Pectins/metabolism , Adhesives/administration & dosage , Adhesives/chemistry , Animals , CHO Cells , Cattle , Cell Survival/drug effects , Cell Survival/physiology , Cellulose/administration & dosage , Cellulose/chemistry , Cricetinae , Cricetulus , Drug Carriers/administration & dosage , Drug Carriers/chemistry , Humans , Mucins/administration & dosage , Mucins/chemistry , Nanofibers/administration & dosage , Nanofibers/chemistry , Pectins/administration & dosage , Pectins/chemistry , Spectroscopy, Fourier Transform Infrared/methods , Tensile StrengthABSTRACT
BACKGROUND: In a prospective clinical study the topical use of a polysaccharide-containing spray for the treatment of xerostomia after radiotherapy in the head and neck area was tested. PATIENTS AND METHODS: A total of 83 patients (evaluable return: n=55) with xerostomia after radiotherapy in the head and neck area received a pump spray with 50 ml Saliva natura (medac, Wedel, Germany) to test for 1 week. The patients were asked to fill in a questionnaire about their xerostomia with and without use of the spray. Individual items included: xerostomia in the state of rest, difficulties speaking, eating and sleeping, frequency of the use of treatment against xerostomia, changes in taste, and saliva viscosity. Additionally, they assessed the spray in general and for taste. RESULTS: Patients reported an improvement in all areas included in the questionnaire. The greatest effect of the spray was seen in sleeping difficulties, which improved by almost a whole point from 3.65 to 2.67, as well as in the frequency of use of xerostomia treatment (averagely 15x/day without and 10x/day with the spray). On average the spray was graded as "satisfactory" (3.09), while its taste was graded as "good" (2.17). CONCLUSION: The tested spray may help improve the situation of patients with xerostomia following radiotherapy in the head and neck area. These patients should be given the opportunity to test a spray of this kind.