Formulation and in Vitro Evaluation of Bromocriptine Mesylate as Fast Dissolving Oral Film

Abstract

Objective: The aim of this study was to formulate and in vitro evaluate fast dissolving oral film of practically insoluble bromocriptine mesylate to enhance its solubility and to improve its oral bioavailability by avoiding first pass effect as well as to produce an immediate release action of the drug from the film for an efficient management of diabetes mellitus type II in addition to an improvement of the patient compliance to this patientfriendly dosage form. Methods:The films were prepared by the solvent casting method using hydroxypropyl methylcellulose of grades (E3, E5, E15), polyvinyl alcohol (PVA), pectin and gelatin as film-forming polymers in addition to polyethene glycol 400 (PEG400), propylene glycol (PG) and glycerin were used as a plasticizer. Poloxamer 407 was used as a surfactant, sodium saccharin as a sweetening agent, citric acid as a saliva stimulating agent, vanilla as a flavouring agent and crospovidone as a super disintegrant. The prepared films then tested for physical characterization, thickness, weight uniformity, mechanical characteristics (folding endurance, tensile strength, percent elongation and Young's modulus), surface pH, in vitro disintegration time, drug content and an in vitro drug release.Results: Films were found to be satisfactory when evaluated for physical characterization, thickness, weight uniformity, mechanical tests, in vitro disintegration time, folding endurance, drug content and an in vitro drug release. The surface pH of all the films was found to be neutral or minor change. Films in vitro drug release studies were also done using USP dissolution apparatus type II (paddle type). The in vitro drug release profile in the optimized formulation F14 was gave 86.8 % of drug released at 2 min. The optimized formulation F14 was also showed satisfactory pH (6.2±0.2), drug content (99.2±0.5%), the disintegration time of 9.2±0.1 seconds and the time needed for 80% of medication to be released (T80 %) was 1.35 minute. Conclusion:The bromocriptine mesylate fast dissolving oral film was formulated. The given film disintegrates within nine seconds which release the drug rapidly and gives an action.

Preparation and Characterization of Lafutidine as Immediate Release Oral Strip Using Different Type of Water-Soluble Polymer

“…So different film-forming polymers gave different DT value as shown in the fig. 1: As expressed in table 3 in which the mechanical properties of OFDFs are listed, the film prepared with HPMC E5 (F1) as film-forming polymer gave satisfactory % E (21.1±0.2), excellent folding endurance value (450±5.5), with low value of youngʼs modulus (105±0.3) and the tensile strength, is about (6.5±0.2), these outcomes were in concurrence with those that reported by Tamer et al [27].…”

“…The mechanical properties of formulas (F1, F7, F8 and F9) were shown in table 3, which illustrated that as the plasticizer concentration increased the young's modulus and the tensile strength decreased. This is due to the fact that the intermolecular forces between polymer chains weakened upon increasing the concentration of plasticizer thus the rigidity of the threedimensional structure formed upon drying decreased [27].…”

Optimization and Evaluation of Chlorpheniramine Maleate Oral Strip for Pediatric Use

“…While F1 (55.8%) and F6 (56.9%) showed, non-significant increment (p>0.05) in D2 min value this may be due to that both plasticizers are water dissolvable and they will diffuse out from the strips in watery media creating void spots in the strip through which distribution of liquid happens to enable strip breaking down leading to improve release profile of drug [35], as shown in Fig. 4.…”

Formulation and In-Vitro Evaluation of Darifenacin Hydrobromide as Buccal Films

“…It was measured by using a standard Vernier caliper. Six films were measured at five positions, and average thickness was calculated (11) .…”

“…FE was determined by manual repeated folding of film at specified site until it breaks or cracks, and average values were calculated and reported. FE of more than 300 gives a good idea about the flexibility and toughness of the formulation (11) .…”