Preparation and Evaluation of Caffeine Orodispersible Films: The Influence of Hydrotropic Substances and Film-Forming Agent Concentration on Film Properties

Author:

Vlad Robert-Alexandru1ORCID,Pintea Andrada2,Coaicea Mădălina3,Antonoaea Paula1,Rédai Emőke Margit1,Todoran Nicoleta1ORCID,Ciurba Adriana1

Affiliation:

1. Pharmaceutical Technology and Cosmetology Department, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, 38th Gheorghe Marinescu Street, 540142 Targu Mures, Romania

2. Targu Mures Clinical County Hospital, 6th Bernady Gyorgy Street, 540072 Targu Mures, Romania

3. Catena Hygeia Darmanesti, 1st Muncii Street, 605300 Bacau, Romania

Abstract

This study aimed to develop caffeine (CAF) orodispersible films (ODFs) and verify the effects of different percentages of film-forming agent and hydrotropic substances (citric acid—CA or sodium benzoate—SB) on various film properties. Hydroxypropyl methylcellulose E 5 (HPMC E 5) orodispersible films were prepared using the solvent casting method. Four CAF-ODF formulations were prepared and coded as CAF1 (8% HPMC E 5, CAF), CAF2 (8% HPMC E 5 and CAF:CA–1:1), CAF3 (9% HPMC E 5 and CAF:CA–1:1), and CAF4 (9% HPMC E 5 and CAF:SB–1:1). The CAF-ODFs were evaluated in terms of disintegration time, folding endurance, thickness, uniformity of mass, CAF content, thickness-normalized tensile strength, adhesiveness, dissolution, and pH. Thin, opaque, and slightly white CAF-ODFs were obtained. All the formulations developed exhibited disintegration times less than 3 min. The dissolution test revealed that CAF1, CAF2, and CAF3 exhibited concentrations of active pharmaceutical ingredients (APIs) released at 30 min that were close to 100%, whilst CAF4 showed a faster dissolution behaviour (100% of the CAF was released at 5 min). Thin polymeric films containing 10 mg of CAF/surface area (3.14 cm2) were prepared.

Publisher

MDPI AG

Subject

Polymers and Plastics,General Chemistry

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