Abstract
Objectives: To systematically evaluate the effects of hydroxypropyl methyl cellulose (HPMC) type (E5LV, E15LV, and K100LV); plasticizer type (glycerol and mannitol), plasticizer loading (0.12 and 0.24% w/w); and loading of prilocaine and lidocaine hydrochlorides combined at 1:1 ratio (0 and 47 mg/cm2) in the mechanical properties of buccal films. Methods: A quality by design (QbD) approach based on a full factorial design (3 x 23) and complementarily multivariate statistical tools i.e., principal component analysis (PCA), response surface methodology (RSM), and correlation matrix were used in this pursuit. The thickness, elongation at break, tensile strength, force at break, and Young`s modulus of the anesthetic buccal films obtained by solvent casting were assessed. Results: The QbD, PCA and RSM altogether demonstrated that all studied formulation variables, mainly the drug loading, affect the mechanical properties of the films at different significance levels. The multivariate analysis yielded the modelling of elongation at break, tensile strength, and force at break, which significantly correlated with each other. The drugs exerted a synergic plasticizing effect on the films, and the use of HPMC K100 LV (with greater hydroxypropyl substitution degree and viscosity) and mannitol favored their elasticity and resistance. Furthermore, the majority of the films fulfilled the requirements for buccal administration due to their softness and mechanical resistance. Conclusion: Mannitol is suitable plasticizer for manufacturing HPMC anesthetic buccal films with improved mechanical properties. These results are a step forward in the rational development of formulations for the replacement of needles in dentistry
Highlights
Over the last decade, our research group has contributed with the development of noninvasive mucoadhesive anesthetic delivery platforms, envisioning the successful replacement of needles in buccal anesthesia[1,2,3,4]
The results showed that these films were able to induce the anesthetic plan within 5 min, and to maintain anesthesia for 50 min in adult patients
Manufacture of anesthetic buccal films using quality by design (QbD) A 3 x 23 full factorial design was used as QbD strategy
Summary
Our research group has contributed with the development of noninvasive mucoadhesive anesthetic delivery platforms, envisioning the successful replacement of needles in buccal anesthesia[1,2,3,4]. This technological strategy has been pursued since needle punctures in dentistry are remarkably painful and uncomfortable, often scaring away patients from dental offices, impairing the treatment success and the quality of life of the patients[5]. The clinical efficacy of mucoadhesive anesthetic films in reducing both the shallow and deep painful sensation associated with simulated buccal infiltration injections was noteworthy. The films presented suitable mucoadhesion both in vitro and in vivo, being safe and very well tolerated by the patients
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