Development of a fast dissolving film of epinephrine hydrochloride as a potential anaphylactic treatment for pediatrics

Alayoubi, Alaadin; Haynes, Lindsay; Patil, Hemlata; Daihom, Baher; Helms, Richard A.; Almoazen, Hassan

doi:10.3109/10837450.2015.1131715

Cited by 15 publications

(7 citation statements)

References 20 publications

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“…After the selection of an optimum plasticizer, different concentrations of Lycoat ® RS780 (1, 5, 10, 15, and 20% w/v ) were screened to select an adequate concentration of the polymer ( Table 3 ). These films were prepared by the solvent casting method as described by Alayoubi, et al [ 26 ] with a slight modification. Initially, a solution of Lycoat ® RS780 and Pearlitol Flash ® (PF) was prepared in distilled water with constant stirring at 500 rpm (AM4, Multiple Heating Magnetic Stirrer, VELP Scientifica, Italy) and 50 °C for 1 h. After cooling, a plasticizer solution was added to the polymeric solution and stirred for 30 min.…”

Section: Methodsmentioning

confidence: 99%

In Vitro and In Vivo Evaluation of Composite Oral Fast Disintegrating Film: An Innovative Strategy for the Codelivery of Ranitidine HCl and Flurbiprofen

et al. 2023

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Here, we evaluate the feasibility of co-loading plain ranitidine hydrochloride (RHCl) and microencapsulated flurbiprofen (FBP) in a Lycoat® RS780-based oral fast disintegrating film (ODF). These films were developed by the solvent casting method to minimize the adverse effects of FBP and reduce the dosage form burden on patients. Optimized FBP microparticles (M3) with an average size of 21.2 ± 9.2 µm were loaded alone (F1) and in combination with plain RHCl (F2) in the composite ODF. All films were evaluated physicomechanically and physicochemically. These films were resilient, flexible, and disintegrated within thirty seconds. SEM images showed intact FBP microparticles in both formulations and, moreover, did not observe an interaction between the drug and film components. Microencapsulated FBP was released in a controlled manner over 48 h from the proposed formulations, while RHCl was released within 5 min from F2. After in vitro evaluation, formulations were also tested for in vivo anti-inflammatory activity, cytokine (TNF-α and IL-6) levels, and gastroprotective effects in rats. The anti-inflammatory activity and gastroprotective effect of F2 were markedly higher than pure FBP and other synthesized formulations (M3 and F1). The average score of gastric lesions was in the order of pure FBP (15.5 ± 1.32) > M3 (8 ± 2) > F1 (1 ± 0.5) > F2 (0.5 ± 0) > control (0). Additionally, F2 showed a sustained anti-inflammatory effect up to 10 h in the rat paw edema model. Furthermore, F2 also markedly reduced TNF-α and IL-6 levels. Conclusively, the Lycoat® RS780-based composite film could be a promising carrier for the co-loading of microencapsulated FBP with RHCl. In the future, an optimized formulation (F2) could be capable of countering the issues related to multiple drug administration in geriatric patients and evading the gastric irritation associated with FBP.

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Section: Methodsmentioning

confidence: 99%

In Vitro and In Vivo Evaluation of Composite Oral Fast Disintegrating Film: An Innovative Strategy for the Codelivery of Ranitidine HCl and Flurbiprofen

et al. 2023

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“…An early disintegration of the film aids in faster dissolution. In CPZ film, a fast disintegration can be attributed to citric acid which acts as a saliva stimulating agent and can further improve the disintegration time of the film (26).…”

Section: Characterization Of Drug-loaded Odfsmentioning

confidence: 99%

Development and Characterization of Taste Masked Orodispersible Film of Chlorpromazine Hydrochloride

Latif¹,

Barkat²,

Afzal³

et al. 2021

Acta Poloniae Pharmaceutica - Drug Research

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Thin-film drug delivery, also referred to as orodispersible film has emerged as an advanced alternative to the traditional tablets, capsules, and liquids. The present work investigates the improvement in solubility to have a rapid onset of action, and palatability of chlorpromazine hydrochloride (CPZ) by developing an orodispersible film (ODF) using the solvent casting method. CPZ indicated for the control of nausea and vomiting, and in the treatment of schizophrenia in adults and children, has low bioavailability (30-50%) when taken orally as a tablet due to extensive first-pass metabolism. Moreover, it is very bitter and has an unpleasant after-taste. In this study, seven placebo formulations were prepared containing different concentrations of film-forming polymers (hydroxypropyl methylcellulose E5 and polyvinyl pyrrolidone K30) and plasticizers (propylene glycol and glycerin), and the most suitable polymer-plasticizer combination was screened to obtain required physical properties. CPZ loaded film was made using an optimized polymer-plasticizer combination employing sucralose and menthol as taste-masking agents. Drug-loaded films were transparent, smooth, and disintegrated in 14.67 ± 1.53 sec. Films showed a folding endurance of > 400, tensile strength of 1.54 ± 0.11 N/mm 2 and percentage elongation of 18.7% ± 0.50 suggesting good mechanical strength. More than 90% drug release was obtained within 3 min in dissolution media. FTIR analysis displayed no significant interactions between drug and polymer. The film was also found palatable with a sweet taste by human volunteers. Hence the taste-masked films of CPZ can be a potential alternative to conventional oral dosage forms and may also enhance patient compliance.

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“…The solvent casting method is the most popular method for the manufacture of FDFs. [69][70][71][72][73][74][75][76][77][78][79][80][81] In this method, all the formulation components are dissolved/dispersed in an aqueous media. Then, the homogenate is cast over a flat and wide surface (usually glass) for drying to form a thin film.…”

Section: Solvent Castingmentioning

confidence: 99%

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

Ehtezazi

Algellay

Hardy

2020

DDF

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: 3D printing technique has been utilised to develop novel and complex drug delivery systems that are almost impossible to produce by employing conventional formulation techniques. For example, this technique may be employed to produce tablets or fast dissolving oral films (FDFs) with multilayers of active ingredients, which are personalised to patient’s needs. In this article, we compared the production of FDFs by 3D printing to conventional methods such as solvent casting. Then, we evaluated the need for novel methods of producing fast dissolving oral films; and why 3D printing may be able to meet the short falls of FDF production. The challenges of producing 3D printed FDFs are identified at commercial scale by referring to the identification of suitable materials, hardware, quality control tests and Process Analytical Technology. In this paper we discuss that the FDF market will grow to more than $1.3 billion per annum in next few years and 3D printing of FDFs may share part of this market. Although, companies are continuing to invest in technologies which provide alternatives to standard drug delivery systems, the market for thin film products is already well established. Market entry for a new technology such as 3D printing of FDFs will, therefore, be hard, unless, this technology proves to be a game changer. A few approaches are suggested in this paper.

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Development of a fast dissolving film of epinephrine hydrochloride as a potential anaphylactic treatment for pediatrics

Abstract: This study presents potential proof for using FDFs as a replacement therapy of epinephrine injections for pediatrics.

Cited by 15 publications

References 20 publications

In Vitro and In Vivo Evaluation of Composite Oral Fast Disintegrating Film: An Innovative Strategy for the Codelivery of Ranitidine HCl and Flurbiprofen

In Vitro and In Vivo Evaluation of Composite Oral Fast Disintegrating Film: An Innovative Strategy for the Codelivery of Ranitidine HCl and Flurbiprofen

Development and Characterization of Taste Masked Orodispersible Film of Chlorpromazine Hydrochloride

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

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