In Vitro/In Vivo Evaluation and Bioavailability Study of Amitriptyline Hydrochloride from the Optimized Oral Fast Dissolving Films

Salman, Zeina D; Maraie, Nidhal K.; Alabbassi, Mustafa Ghazi; Ghareeb, Mowafaq M.

doi:10.20510/ukjpb/2/i6/91171

Cited by 14 publications

(5 citation statements)

References 12 publications

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“…While F1 (46.2/43.8 s) and F6 (45.1/43.3 s) showed non-significant diminution (p>0.05) in vitro/in vivo DT this may be due to the fact that the two types of plasticizers enhanced the DT by facilitating the penetration of fluids into the strip, since plasticizer alter the densely packed chains of HPMC texture by forming the polymer structure possessing more pores and less density that breaks at lower force, resulting in faster disintegration of the film [33].…”

Section: Effect Of Different Plasticizer Types On In Vitro/in Vivo Dtmentioning

confidence: 93%

Optimization and Evaluation of Chlorpheniramine Maleate Oral Strip for Pediatric Use

Mahmood

Sabry

Yousif

et al. 2018

Asian J Pharm Clin Res

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Objective:The goal of performing this study is to prepare an oral strip, especially designed for pediatric use that provides fast onset of action with ease of swallowing particularly for young individuals who suffer from difficulty of swallowing, in addition provides maximum therapeutic effectiveness by reducing the first pass effect. Materials and Methods:The oral strip was prepared by solvent casting technique through using different sole polymers (hydroxypropyl methylcellulose [HPMC] 15cp, HPMC 50cp, polyvinyl alcohol, and sodium carboxymethyl cellulose). Maltodextrin (MD) was added as the secondary polymer in different ratios to optimize the release parameters, and disintegration time (DT), three different plasticizers were employed (propylene glycol, dibutyl phthalate, and glycerin) to boost the film forming polymer characteristics.Results: From this study, it is obvious that F10 which composed of HPMC as a main polymer and MD as a secondary polymer in ratio 2:1, respectively, provides adequate physicochemical characteristics, in vitro/in vivo DT DT (40/36 s), respectively, nevertheless a satisfactory release parameters as (59.9%) released at 2 min and 80% of drug released at 14.8 min. Conclusion:The optimized formula is pretty encouraging to originate an oral strip that provides ease of administration, fast onset of action with wide acceptance for the pediatric population.

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Section: Effect Of Different Plasticizer Types On In Vitro/in Vivo Dtmentioning

confidence: 93%

Optimization and Evaluation of Chlorpheniramine Maleate Oral Strip for Pediatric Use

Mahmood

Sabry

Yousif

et al. 2018

Asian J Pharm Clin Res

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“…The results showed that changing of plasticizer type caused no significant effect (p>0.05) on the in vitro DT of mouth dissolving strips, as show in fig. (7), this may be due to the fact that three types of plasticizer enhanced the disintegration time by facilitating the penetration of fluids into the strip, since plasticizer alter the densely packed chains of HPMC texture by forming a polymer structure possess more pores and less densely that breaks at lower force, resulting in faster disintegration of the film [36].…”

Section: Effect Of Concentrations Of Selected Polymer (Hpmc E5)mentioning

confidence: 99%

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

2018

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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.

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“…Accordingly, sublingual medication administration is quicker and more impressible compared to the easily administered oral medication. 23 The thin and extremely permeable membrane of the sublingual mucosa is an appropriate target if a rapid start is favored. Additionally, significant surface area and upper blood flow at this area provide fast availability to the systemic circulation.…”

Section: Discussionmentioning

confidence: 99%

Fast Dissolving Sublingual Strips: A Novel Approach for the Delivery of Isosorbide Dinitrate

et al. 2019

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Background: Isosorbide dinitrate (ISDN) is used for treating the angina attacks. In addition, oral ISDN is available in immediate and sustained release formulations and the bioavailability of ISDN is about 20-25% when taken orally. Further, the ISDN films are developed for sublingual drug delivery by improving drug bioavailability. The present study aimed to design and evaluate the physicochemical properties of the film formulation for sublingual delivery of ISDN. Methods: In the present study, sublingual films were prepared by the solvent casting technique using the hydroxypropyl methylcellulose (HPMC) polymers (i.e., 100, 150 and 200 mg) with a different drug to polymer ratios (i.e., 1:5, 1:7.5 and 1:10). Then, ISDN was evaluated for the film appearance, drug content, surface pH, mucoadhesion force, differential scanning calorimetry (DSC), in vitro drug release, and ex vivo permeability. Results: Based on the results, F3 formulation (1:10 ISDN to HPMC ratio) showed acceptable thickness (0.93 mm), weight (11.14 mg), surface pH (7.82), moisture absorption capacity (6.08%), elasticity (>200), mucoadhesion force (18.05 N/cm2), and drug content (6.22%). Furthermore, the results demonstrated that HPMC polymer improved the characteristics of the films, modified the bioadhesiveness, and finally, enhanced elasticity. However, DSC thermogram failed to show any crystalline drug substance in the films except for F1 (immediate release) and the endothermic peak of ISDN was absent in F2 and F3 films. Therefore, the drug which was entrapped into the film was in an amorphous or disturbed-crystalline phase of the molecular dispersion or dissolved in the melted polymer in the polymeric matrix. Moreover, the drug release from the films was faster compared to the tablet® (P<0.05). Conclusion: In general, the formulation of F1 was observed to be an appropriate candidate for developing the sublingual film for the remedial use.

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In Vitro/In Vivo Evaluation and Bioavailability Study of Amitriptyline Hydrochloride from the Optimized Oral Fast Dissolving Films

Cited by 14 publications

References 12 publications

Optimization and Evaluation of Chlorpheniramine Maleate Oral Strip for Pediatric Use

Optimization and Evaluation of Chlorpheniramine Maleate Oral Strip for Pediatric Use

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

Fast Dissolving Sublingual Strips: A Novel Approach for the Delivery of Isosorbide Dinitrate

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