Bilayered buccal films as child-appropriate dosage form for systemic administration of propranolol

Abruzzo, Angela; Nicoletta, Fiore Pasquale; Dalena, Francesco; Cerchiara, Teresa; Luppi, Barbara; Bigucci, Federica

doi:10.1016/j.ijpharm.2017.08.070

Cited by 43 publications

(41 citation statements)

References 35 publications

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“…For this study, freshly isolated porcine esophageal mucosa was employed on the basis of its similarity to the buccal one [34]. The mucosa was isolated from pig esophageal tissue, purchased from a local slaughterhouse, following the procedure described in our previous work [35]. For the evaluation of in vitro residence time, the mucosa (surface area of 4 cm 2 ) was pasted on a glass slide using cyanoacrylate adhesive and hydrated with 20 µL of phosphate buffer at pH 6.8 for 5 min.…”

Section: In Vitro Residence Time and Mucoadhesive Ability Of Buccal Fmentioning

confidence: 99%

“…The time taken by the film for complete detachment from the mucosa was considered as the residence time [36]. Mucoadhesive ability was measured in terms of the force needed to pull out the mucosa from the film with an adapted tensiometer (Krüss 132869; Hamburg, Germany) [26,35]. The mucosa was hydrated for 5 min with phosphate buffer at pH 6.8, fixed to a support (surface area 1 mm 2 ) with cyanoacrylate adhesive and then suspended from the tensiometer.…”

Section: In Vitro Residence Time and Mucoadhesive Ability Of Buccal Fmentioning

confidence: 99%

“…For this study, the film was attached to a glass slide using cyanoacrylate adhesive and then placed in 20 mL of phosphate buffer at pH 6.8 under stirring (50 rpm) for 360 min. Films were attached facing the loaded face towards the glass slide or the buffer, in order to evaluate the amount of lattobacilli released over time from the different film faces [35]. Samples were taken at predetermined time points, replaced by fresh medium and analyzed by spectroscopy at 600 nm.…”

Section: In Vitro Release Of L Brevismentioning

confidence: 99%

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Mucoadhesive Buccal Films for Local Delivery of Lactobacillus brevis

et al. 2020

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The aim of this work was to prepare mucoadhesive buccal films for local release of Lactobacillus brevis CD2, which shows interesting anti-inflammatory properties due to its high levels of arginine deiminase. Hydroxypropylmethylcellulose-based films were prepared by means of a modified casting method, which allowed L. brevis CD2 loading on one side of the film, before its complete drying. Three batches of films were prepared, stored at +2-8 • C and +23-25 • C for 48 weeks and characterized in terms of physico-chemical and functional properties. For each batch, the L. brevis viable count and arginine deiminase activity were evaluated at different time points in order to assess functional property maintenance over time. Moreover, the mucoadhesive properties and ability of the films to release L. brevis CD2 were evaluated. A good survival of L. brevis CD2 was observed, particularly at the storage temperature of +2-8 • C, while the activity of arginine deiminase was maintained at both temperature values. Films showed good mucoadhesive properties and guaranteed a prolonged release of viable lactobacilli, which can be directed towards the whole buccal cavity or specific mucosa lesions. In conclusion, the proposed preparative method can be successfully employed for the production of buccal films able to release viable L. brevis CD2 cells that maintain the anti-inflammatory enzymatic activity.

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Section: In Vitro Residence Time and Mucoadhesive Ability Of Buccal Fmentioning

confidence: 99%

Section: In Vitro Residence Time and Mucoadhesive Ability Of Buccal Fmentioning

confidence: 99%

Section: In Vitro Release Of L Brevismentioning

confidence: 99%

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Mucoadhesive Buccal Films for Local Delivery of Lactobacillus brevis

et al. 2020

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“…FDBF (F6) was cut into fine pieces using a sharp cutter. Each sample was then scanned at temperature condition, i.e., 30 to 350 ∘ C with constant heating rate of 10 ∘ C/min using nitrogen gas flow rate of 20 mL/min [26,27].…”

Section: Ingredientsmentioning

confidence: 99%

Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes

Dangre

Phad

Surana

et al. 2019

Advances in Polymer Technology

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The present work endeavors fabrication of fast dissolving buccal film of clonidine hydrochloride by employing quality by design (QbD) based approach. The total nine formulations were prepared according to formulation by design helped by JMP software 13.2.1. The patient oriented quality target product profiles were earmarked and on that basis critical quality attributes were identified. Preliminary screening studies along with initial risk assessment eased the selection of film-forming polymer (HPMC E 15) and plasticizer (PEG 400) as CMAs for formulation of films. A 32 full factorial plan was utilized for assurance of impact, i.e., HPMC E15 (X1) and PEG 400 (X2), as independent variables (factors) on thickness (mm) (Y1), disintegration time (s) (Y2), folding endurance (Y3), and tensile strength (kg) (Y4). Furthermore, prediction profiler assists in predicting composition of best formulation encompassing desired targeted response. The optimized formulation (F6) showed fast drug dissolution (>90%) within 8 min, and solid state characterization by DSC, XRD revealed excellent film characteristics. In a nutshell, the fast dissolving buccal film for clonidine hydrochloride was successfully developed assisted by QbD approach with markedly improved biopharmaceutical performance as well as patient compliance.

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“…If adhesion is to a mucous coat, the phenomenon is referred to as mucoadhesion. 3,4 The use of mucoadhesive polymers in buccal drug delivery has a greater application. Buccal route of drug delivery provides the direct access to the systemic circulation through the jugular vein bypassing the first pass hepatic metabolism leading to high bioavailability.…”

Section: Introductionmentioning

confidence: 99%

Formulation and Evaluation of Mucoadhesive Patches of Ivabradine Hydrochloride

Roy¹,

Sowmya²,

Srija³

et al. 2018

Int. Res. J. Pharm.

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The objective of this study was to develop a mucoadhesive buccal patch of Ivabradine hydrochloride using mucoadhesive polymers such as carbopol, poloxamer, and HPMC 15LV. During this study polyvinylpyrrolidone, ethyl cellulose considered as a thickening agent or rate controlling polymer. A total number of five formulations were prepared by a solvent evaporation method. The prepared mucoadhesive patches were evaluated for in-vitro dissolution, drug content, folding endurance, mucoadhesive strength, swelling index, and drug-polymer interaction study. From the present study, it found that the mean thickness of the buccal polymeric patches increased with an increase in the amount of polymer percent. Percent swelling index determined at 2, 4, 6 and 8 hrs increased with time and with an increase in the polymer. The in-vitro study was performed by phosphate buffer PH 6.8 in Franz diffusion cell. During the study, it was also found that an increase in the amount of polymer retarded the release of the drug. Formulation F3 released 100% of the drug in 10 hrs of time. There was no such interaction found between drug and excipients.

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Bilayered buccal films as child-appropriate dosage form for systemic administration of propranolol

Cited by 43 publications

References 35 publications

Mucoadhesive Buccal Films for Local Delivery of Lactobacillus brevis

Mucoadhesive Buccal Films for Local Delivery of Lactobacillus brevis

Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes

Formulation and Evaluation of Mucoadhesive Patches of Ivabradine Hydrochloride

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