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Journal ArticleDOI

Advances in orodispersible films for drug delivery.

19 Feb 2011-Expert Opinion on Drug Delivery (Expert Opin Drug Deliv)-Vol. 8, Iss: 3, pp 299-316
TL;DR: The magnitude of variants of ODF technology and the advantages over conventional dosage forms promise more applications and more marketed products with ODFs in the near future.
Abstract: Introduction: Orodispersible films for oral delivery are gaining popularity. Whereas breath-fresheners and over-the-counter products have already become quite common in the US, the first prescription drug films were introduced into the EU and US markets only very recently. Already considered as a unique Rx (prescription drug) dosage form by the FDA (oral soluble film), such products are not substitutable by conventional oral dosage forms. The official term defined by the European Medicines Agency is orodispersible film (ODF). Areas covered: This review gives an overview on the benefits of ODFs, typical excipients and products already available on the market. ODFs are defined and differentiated from other films and dosage forms. Possible manufacturing methods are described. As ODFs are not yet listed in one of the pharmacopoeias, possible methods for characterization and quality control are discussed. Required characteristics, advantages and disadvantages are elaborated. Biopharmaceutical considerations ar...
Citations
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Journal ArticleDOI
TL;DR: The aim of this review is to provide an overview of the critical factors affecting the formulation of thin films, including the physico-chemical properties of polymers and drugs, anatomical and physiological constraints, as well as the characterization methods and quality specifications to circumvent the difficulties associated with formulation design.

332 citations


Cites background from "Advances in orodispersible films fo..."

  • ...Orodispersible films should not be misunderstood with buccal films designed for staying longer on the cheek mucosa [24]....

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Journal ArticleDOI
TL;DR: This pharmaceutical form with a blustering beginning as a breath freshener had an emergent entrance in the Rx market proving its reliable value, and is described and explores the oral film technology from its main component, the polymeric matrices, to the new and possible market applications.

206 citations

Journal ArticleDOI
TL;DR: Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development.
Abstract: Introduction: Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability. Areas covered: The current approaches and novel developments in the field of age-appropriate drug delivery for pediatric patients are critically discussed including patient-centric formulations, administration devices and packaging systems. Expert opinion: Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. A collaborative approach will benefit not only pediatrics, but other patient populations such as geriatrics would also benefit from an accelerated patient-centric approach to drug delivery.

178 citations


Cites background from "Advances in orodispersible films fo..."

  • ...The use of milk as a vehicle for the administration of drugs was also at the background of the development of a ‘nipple shield’ delivery system (Figure 2), which is designed to accommodate a drug-loaded insert delivering the API into milk while breastfeeding neonates [20,21]....

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  • ...For this reason, the time required to achieve complete dissolution of the API should be determined and stated in the product label....

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  • ...Preferably, ODFs should be sealed individually in order to improve stability and reduce the risk of overdosing due to films sticking together [74]....

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  • ...This can be achieved by simply combining multiparticulates with different APIs and/or different release characteristics into the same dosage form, respectively....

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  • ...Thus flexible technology platforms are desired enabling the preparation of formulations with different active pharmaceutical ingredients (APIs), dose strengths and/or release profiles [1,10]....

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Journal ArticleDOI
TL;DR: This review presents an overview of the re-ported drugs loaded into polymeric nanofibers, to be used as drug delivery systems, and uncovers the advantages of electrospunpolymeric nan ofibers over other drug delivery system.
Abstract: Recently, electrospun polymeric nanofibers have proven to be an interesting strategy for drug delivery systems application. The high surface-to-volume ratio of the fibers can improve some processes, such as cell binding and proliferation, drug loading, and mass transfer processes. One of the most important and studied areas of electrospinning is in the drug delivery field, for the controlled release of active substances ranging from antibiotics and anticancer agents to macromolecules such as proteins and DNA. The advantage of this method is that a wide variety of low solubility drugs can be loaded into the fibers to improve their bioavailability or to attain controlled release. This review presents an overview of the reported drugs loaded into polymeric nanofibers, to be used as drug delivery systems. For instance, it presents the reports on drugs with different bioactivities such as antiinflammatory, anti-microbial, anticancer, cardiovascular, anti-histamine, gastrointestinal, palliative and contraceptive drugs, etc. It also analyzes the electrospinning techniques used in each system, as well as the polymers used as matrices for the preparation of the nanofibers; unfolding the advantages of electrospun polymeric nanofibers over other drug delivery systems. This review intends to enlist and summarize the reported literature concerning this topic. In addition, it proposes future research in the field.

177 citations


Cites background from "Advances in orodispersible films fo..."

  • ...Gastrointestinal disease is the name given to all of those diseases that damage the digestive system (esophagus, stomach, small intestine, large intestine and rectum, and the accessory organs of digestion: liver, gallbladder, and pancreas) [55]....

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Journal ArticleDOI
TL;DR: The review reports the recent advances, existing and upcoming products, and the significance of formulating patient-friendly oral dosage forms on the basis of regulatory guidelines and pharmacopoeial monographs to foster the development of innovative orodispersible drug dosage forms.

175 citations


Cites background from "Advances in orodispersible films fo..."

  • ...The casted films are cut into suitable sizes for oral administration (e.g. 2 4 cm) and sealed in moisture-protecting packages (Hoffmann et al., 2011)....

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References
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Journal Article
TL;DR: The structure and environment of the oral mucosa and the experimental methods used in assessing buccal drug permeation/absorption are discussed and bioadhesive polymeric based delivery systems are reviewed.
Abstract: Within the oral mucosal cavity, the buccal region offers an attractive route of administration for systemic drug delivery. The mucosa has a rich blood supply and it is relatively permeable. It is the objective of this article to review buccal drug delivery by discussing the structure and environment of the oral mucosa and the experimental methods used in assessing buccal drug permeation/absorption. Buccal dosage forms will also be reviewed with an emphasis on bioadhesive polymeric based delivery systems

653 citations


"Advances in orodispersible films fo..." refers background in this paper

  • ...Oral mucosa is described in detail elsewhere [62,73,74,81]....

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  • ...The permeability of the oral mucosa decreases in the order sublingual to buccal to palatal [74]....

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  • ...For the development of sustained-release films or oral patches, some tests on bioadhesion can be helpful [22,55,62,73,74]....

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  • ...Usually mucosal tissue from animals is used as surrogates for human mucosa, for example, porcine mucosa [62,73,74]....

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Journal ArticleDOI
R.P. Dixit1, S.P. Puthli1
TL;DR: The review article is an overview of OST encompassing materials used in OST, critical manufacturing aspects, applications, commercial technologies and future business prospects of this technology.

539 citations


"Advances in orodispersible films fo..." refers background in this paper

  • ...A residual water content is necessary to obtain flexible films [19]....

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  • ...Natural gums such as xanthan or guar gum can improve viscosity and film-forming capacity [19,20,42]....

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  • ...De-aeration of the coating mass is achieved by continuous stirring and application of a vacuum [1,19]....

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  • ...The end point of drying has to be controlled carefully [19,27]....

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  • ...If the drug is absorbed through the oral mucosa, first-pass metabolism can be avoided for some drugs, which may improve bioavailability [18,19]....

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Journal ArticleDOI
TL;DR: In order to make a compressed tablet which can rapidly disintegrate in the oral cavity, microcrystalline cellulose and low-substituted hydroxypropylcellulose were used as disintegrants, and ethenzamide and ascorbic acid were chosen as poorly and easily water soluble model drugs, respectively.
Abstract: In order to make a compressed tablet which can rapidly disintegrate in the oral cavity, microcrystalline cellulose and low-substituted hydroxypropylcellulose were used as disintegrants, and ethenzamide and ascorbic acid were chosen as poorly and easily water soluble model drugs, respectively. The mixture of microcrystalline cellulose and low-substituted hydroxypropylcellulose was compressed at 100--500 kgf in the absence of an active ingredient. The properties of these tablets, such as hardness, porosity, the time required for complete wetting of a tested tablet (wetting time), water uptake and disintegration time determined by a new disintegration apparatus, were investigated to elucidate the wetting and disintegration characteristics of these tablets, When the MCC/L-HPC ratio was in the range of 8:2 to 9:1, the shortest disintegration time was observed. The disintegration of tablets containing ethenzamide or ascorbic acid was examined next. Tablet disintegration time in the oral cavity was also tested, and good correlation between the disintegration behaviors in vitro and in the oral cavity was recognized.

476 citations


"Advances in orodispersible films fo..." refers methods in this paper

  • ...developed a disintegration test for orodispersible tablets using a modified dissolution apparatus, which might work for ODFs as well, although an unphysiologically high volume of dissolution medium is applied [69]....

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Book
17 Apr 2007
TL;DR: Modified-release drug delivery technology, Modified-release drugs delivery technology , and modified-release delivery technology are used in medicine and medical equipment.
Abstract: Modified-release drug delivery technology , Modified-release drug delivery technology , کتابخانه مرکزی دانشگاه علوم پزشکی تهران

454 citations

Journal ArticleDOI
TL;DR: The main modifications made during the revision of the current Note for Guidance on the Investigation of Bioavailability and Bioequivalence are reviewed and justified and several new features have been added to this guideline.
Abstract: In this MiniReview, the main modifications made during the revision of the current Note for Guidance on the Investigation of Bioavailability and Bioequivalence are reviewed and justified Several new features have been added to this guideline, as well as changes aimed at improving the clarity of the guidance provided The first issue to be addressed was to limit the scope of the guideline to bioequivalence studies for immediate release dosage forms with systemic action Therefore, the guideline refers to bioequivalence alone Moreover, the new definition of Generic Medicinal Product has been incorporated Clearer guidance covering more specific cases is now given on sections such as: fed/fasting conditions, use of metabolite data, enantiomers and strength to be used in the bioequivalence study Steady-state design is now restricted and other designs, such as parallel group design, replicate design and two-stage design, are now incorporated in a more explicit form New practical guidance on Highly Variable Drug Products and Narrow Therapeutic Index Drugs has been incorporated The possibility for a biowaiver based on the Biopharmaceutics Classification System is now more explicit for Class I drugs and can be extended to Class III drugs under restricted conditions We are aware that the initial goal of providing a very specific and clear guidance on these issues has not been entirely achieved, mainly because it is almost impossible to cover all individual cases and predict every possible situation that may arise Demonstration of bioequivalence will still require in many instances a case by case approach

386 citations