Concept of Orodispersible or Mucoadhesive “Tandem Films” and Their Pharmaceutical Realization
Orodispersible or mucoadhesive films as a patient-oriented dosage form for low-dosed drugs are usually produced using solvent casting. This paper presents a modification of the solvent casting technique that aimed to divide oral films into two or more compartments.
The proposed objectives and fields of applications include improved handling properties and safety of application, the optimization of drug release kinetics and the enhancement of long-term stability when combining two or more active pharmaceutical ingredients into one oral film. A feasibility study for the combination of different film-forming polymers to generate the so-called tandem films was performed.
As examples of practical implementation, orodispersible applicator films consisting of a drug-loaded section and a handheld piece were cast, and mucoadhesive buccal tandem films were cast to optimize the dissolution rate of the films.
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Materials:Hypromellose (HPMC, Pharmacoat®603/606, Shin Etsu, Chiyoda, Tokyo, Japan; substitution type 2910), hyprolose (HPC, Nisso HPC SL, Nippon Soda, Tokyo, Japan; molar substitution 3.62 [28]), polyvinyl alcohol (PVA, PE-05JPS, JVP, Osaka, Japan; degree of hydrolysis 88%), pullulan (Tokyo Chemical Industry, Tokyo, Japan), ethyl cellulose (EC,AqualonTM N10/N22, Ashland, Wilmington, DE, USA; ethoxyl substitution 48.0–49.5%) and polyacrylic acid (Carbopol 971P NF,Lubrizol, OH, USA) were used as polymeric film formers. Anhydrous glycerol (Caelo, Hilden, Germany) and triethyl citrate (TEC, Citrofol®AI, Jungbunzlauer, Swizerland) were used as plasticizers. Tragacanth (Merck Millipore, Burlington, MA, USA) was used as a thickening agent and microcrystalline cellulose (MCC,Vivapur 101,JRS Pharma, Rosenberg, Germany),sodium starch glycolate (SSG, Vivastar P, JRS Pharma), povidone (PVP,科利当90 F, BASF, Ludwigshafen, Germany), crospovidone (PVP-Cl,Kollidon Cl, BASF) and sodium croscarmellose (CMC,Ac-Di-Sol SD-711, DuPont de Nemours, Wilmington, DE, USA) as disintegrants. Deionized water and ethanol of analytical grade were used as solvents. Bisoprolol hemifumarate (Arevipharma GmbH, Radebeul, Germany) and theophylline monohydrate (BASF) were used as active ingredients. Amaranth (BASF) was used as a colorant and disodium hydrogen phospahe (Carl Roth, Karlsruhe, Germany) and phosphoric acid 85% (Sigma-Aldrich, Steinheim, Germany) as buffering agents.
Article information: Göbel, A.; Breitkreutz, J. Concept of Orodispersible or Mucoadhesive “Tandem Films” and Their Pharmaceutical Realization.Pharmaceutics2022,14, 264. https://doi.org/10.3390/pharmaceutics14020264