Recent advances of oral film as platform for drug delivery

He, Mengning; Zhu, Lingmeng; Ni, Yang; Li, Huijie; Yang, Qingliang

doi:10.1016/j.ijpharm.2021.120759

Cited by 73 publications

(50 citation statements)

References 113 publications

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“…Patients like pediatric, elderly, or those who have difficulty swallowing or dysphasia may often refuse conventional oral dosages such as tablets or capsules objectively [ 1 , 2 , 3 ]. In addition to the abovementioned populations, there are other patients such as the developmentally disabled, mentally ill, or uncooperative who may be subjectively unwilling to take the conventional oral dosages as well [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies

Zhang

Thakkar

et al. 2021

Pharmaceutics

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Conventional oral dosage forms may not always be optimal especially for those patients suffering from dysphasia or difficulty swallowing. Development of suitable oral thin films (OTFs), therefore, can be an excellent alternative to conventional dosage forms for these patient groups. Hence, the main objective of the current investigation is to develop oral thin film (OTF) formulations using novel solvent-free approaches, including additive manufacturing (AM), hot-melt extrusion, and melt casting. AM, popularly recognized as 3D printing, has been widely utilized for on-demand and personalized formulation development in the pharmaceutical industry. Additionally, in general active pharmaceutical ingredients (APIs) are dissolved or dispersed in polymeric matrices to form amorphous solid dispersions (ASDs). In this study, acetaminophen (APAP) was selected as the model drug, and Klucel™ hydroxypropyl cellulose (HPC) E5 and Soluplus® were used as carrier matrices to form the OTFs. Amorphous OTFs were successfully manufactured by hot-melt extrusion and 3D printing technologies followed by comprehensive studies on the physico-chemical properties of the drug and developed OTFs. Advanced physico-chemical characterizations revealed the presence of amorphous drug in both HME and 3D printed films whereas some crystalline traces were visible in solvent and melt cast films. Moreover, advanced surface analysis conducted by Raman mapping confirmed a more homogenous distribution of amorphous drugs in 3D printed films compared to those prepared by other methods. A series of mathematical models were also used to describe drug release mechanisms from the developed OTFs. Moreover, the in vitro dissolution studies of the 3D printed films demonstrated an improved drug release performance compared to the melt cast or extruded films. This study suggested that HME combined with 3D printing can potentially improve the physical properties of formulations and produce OTFs with preferred qualities such as faster dissolution rate of drugs.

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Section: Introductionmentioning

confidence: 99%

Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies

Zhang

Thakkar

et al. 2021

Pharmaceutics

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“…Multiple studies have laid emphasis on the OF importance compared with traditional methods of drug delivery [7]. However, the guidelines for production and commercialization are not completely defined [16] and it is important to draw attention to this problem because there are already many products on the market, especially in nutraceuticals market and over-the-counter [3,19].…”

Section: Discussionmentioning

confidence: 99%

“…Several molecules can be incorporated into these delivery systems, such as benzocaine, phenylephrine, sildenafil, ondansetron, chlorhexidine, captopril, as well as neuromodulator molecules (donepezil, tianeptine, zaleplon, paracetamol, buspirone hydrochloride, aripiprazole, caffeine) [2,[6][7][8][9][10][11]. These active molecules can be carried in dispersed or loaded form into microparticles or nanoparticles depending on the physicochemical properties of the drug and the desired release pattern [1,9,[12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

Validation of Psychophysiological Measures for Caffeine Oral Films Characterization by Machine Learning Approaches

et al. 2022

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(1) Background: The oral films are a new delivery system that can carry several molecules, such as neuromodulator molecules, including caffeine. These delivery systems have been developed and characterized by pharmacokinetics assays. However, new methodologies, such as psychophysiological measures, can complement their characterization. This study presents a new protocol with psychophysiological parameters to characterize the oral film delivery systems based on a caffeine model. (2) Methods: Thirteen volunteers (61.5% females and 38.5% males) consumed caffeine oral films and placebo oral films (in different moments and without knowing the product). Electrocardiogram (ECG), electrodermal (EDA), and respiratory frequency (RF) data were monitored for 45 min. For the data analysis, the MATLAB environment was used to develop the analysis program. The ECG, EDA, and RF signals were digitally filtered and processed, using a windowing process, for feature extraction and an energy mean value for 5 min segments. Then, the data were computed and presented to the entries of a set of Machine Learning algorithms. Finally, a data statistical analysis was carried out using SPSS. (3) Results: Compared with placebo, caffeine oral films led to a significant increase in power energy in the signal spectrum of heart rate, skin conductance, and respiratory activity. In addition, the ECG time-series power energy activity revealed a better capacity to detect caffeine activity over time than the other physiological modalities. There was no significant change for the female or male gender. (4) Conclusions: The protocol developed, and the psychophysiological methodology used to characterize the delivery system profile were efficient to characterize the drug delivery profile of the caffeine. This is a non-invasive, cheap, and easy method to apply, can be used to determine the neuromodulator drugs delivery profile, and can be implemented in the future.

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“…Over the last two decades, transdermal drug delivery (TDD) has received extensive interest as it has a number of advantages over conventional drug delivery systems, including its simplicity, pre-determined doses, convenience in handling, patient self-administration, and comparatively lax storage conditions. However, when it comes to drug molecules with low solubility, permeability, and degradation, the oral route of drug administration has several drawbacks [1][2][3]. The oral bioavailability of drugs varies greatly because most drugs administered orally undergo first-pass metabolism and confront many physical and biological barriers, resulting in dramatically reduced bioavailability [2,4].…”

Section: Introductionmentioning

confidence: 99%

“…However, when it comes to drug molecules with low solubility, permeability, and degradation, the oral route of drug administration has several drawbacks [1][2][3]. The oral bioavailability of drugs varies greatly because most drugs administered orally undergo first-pass metabolism and confront many physical and biological barriers, resulting in dramatically reduced bioavailability [2,4]. Parenteral drug delivery is the most effective means for delivering drugs with a narrow therapeutic index and low bioavailability, particularly in situations where patient compliance cannot be assured (i.e., unconscious patients) [5].…”

Section: Introductionmentioning

confidence: 99%

Beneath the Skin: A Review of Current Trends and Future Prospects of Transdermal Drug Delivery Systems

et al. 2022

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The ideal drug delivery system has a bioavailability comparable to parenteral dosage forms but is as convenient and easy to use for the patient as oral solid dosage forms. In recent years, there has been increased interest in transdermal drug delivery (TDD) as a non-invasive delivery approach that is generally regarded as being easy to administer to more vulnerable age groups, such as paediatric and geriatric patients, while avoiding certain bioavailability concerns that arise from oral drug delivery due to poor absorbability and metabolism concerns. However, despite its many merits, TDD remains restricted to a select few drugs. The physiology of the skin poses a barrier against the feasible delivery of many drugs, limiting its applicability to only those drugs that possess physicochemical properties allowing them to be successfully delivered transdermally. Several techniques have been developed to enhance the transdermal permeability of drugs. Both chemical (e.g., thermal and mechanical) and passive (vesicle, nanoparticle, nanoemulsion, solid dispersion, and nanocrystal) techniques have been investigated to enhance the permeability of drug substances across the skin. Furthermore, hybrid approaches combining chemical penetration enhancement technologies with physical technologies are being intensively researched to improve the skin permeation of drug substances. This review aims to summarize recent trends in TDD approaches and discuss the merits and drawbacks of the various chemical, physical, and hybrid approaches currently being investigated for improving drug permeability across the skin.

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Recent advances of oral film as platform for drug delivery

Cited by 73 publications

References 113 publications

Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies

Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies

Validation of Psychophysiological Measures for Caffeine Oral Films Characterization by Machine Learning Approaches

Beneath the Skin: A Review of Current Trends and Future Prospects of Transdermal Drug Delivery Systems

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