Recent Advancement: 3D-Printed Orodispersible Film as Pharmaceutical Dosage Forms for Paediatric Patients

Abstract

Traditional drug delivery systems are often unsuitable for paediatric patients due to their unique developmental stages and specific dosing requirements are distinct from those of other groups within the population. Oral delivery is recognized as the most user-friendly and popular method in therapeutic practices due to its safety, high patient compliance, ease of administration, affordable price, and flexibility. The challenge of medication adherence is increasingly recognized as a critical public health issue, with poor adherence to treatment linked to negative health consequences and higher patient expenses. The current approaches and recent advancement 3d printed oral film in the field of age-appropriate medicament delivery for paediatric patients are critically discussed including personalized formulations. To effectively address this issue, interventions must be tailored to the unique characteristics of therapeutic regimens that reflect the needs of patients. Special attention should be given to the geriatric and paediatric populations, as their particular needs and preferences are vital considerations in the design of pharmaceutical products. 3D-printing technologies provide the capability to design dosage forms that are customized to the needs of individual patients. This technology can also be leveraged to create shapes that are more appealing to children, such as stars and flowers, potentially improving adherence in this demographic. The objective of this mini review is to outline the existing 3D printing technologies utilized in the fabrication of oral films, to present their respective advantages and limitations, and to explore a range of formulation strategies.

Keywords

3D-Printing, Oral film, Paediatric patient, Technologies, drug delivery. Abbreviation: Orodispersible films, (ODFs); orodispersible tablets, (ODTs); active pharmaceutical ingredient, (API); three-dimensional printing, (3D-printing); Continuous Inkjet (CIJ); Drop-On-Demand, (DOD); Fused Deposition Modelling, (FDM); Semi-Solid Extrusion, (SSE); Hot melt extrusion, HME; Selective laser sintering, (SLS); Direct Powder Extrusion, (DPE);

Introduction

       
           
       
Fig no. 1: Ideal features of Oro-dispersible film

Moreover, they are stable, and effective, and improve bioavailability by reducing the effects of first-pass metabolism.^[9] Upon intake, orally disintegrating films (ODF) dissolve promptly upon contact with saliva in the oral cavity, resulting in the release of the active pharmaceutical ingredient (API). This characteristic enables the oral administration of drugs to patients for whom conventional oral formulations may not be the preferred option, especially in cases of swallowing difficulties. Furthermore, recent advancements in manufacturing and compounding processes have provided the capability to create tailored drug formulations that meet the individual needs of patients, thereby enhancing the potential applications of ODFs.^[10]

       
           
       
Fig no. 2: Advantages of 3D-Printed dosage form in pharmaceutical field.

Fabrication Technique of oro-dispersible film

       
           
       
Fig no. 3: Schematic diagram of inkjet based by thermal and piezoelectric techniques.

Extrusion-based 3D printing system

       
           
       
Fig no. 4: 3D-Printed Orodispersible Film via Hot melt extrusion-based technique.

2. Semi-solid extrusion (SSE)

The technique of SSE involves the application of ink or gel at low temperatures, specifically between room temperature and 40 ?C. SSE formulations are primarily formulated with a binding agent and a selection of excipients, including fillers, which are determined by the nature of the intended printed object, such as orodispersible dosage forms. The viscosity of the ink is a critical factor influencing the printability of the formulation. The presence of high viscosity in ink formulations leads to a semi-solid consistency that requires significant pressure for extrusion, thereby heightening the risk of nozzle obstruction. In contrast, low-viscosity inks are prone to leaking from the nozzle, making deposition challenging. As a result, the formulation of these inks and the choice of excipients are guided by rheological evaluations, which encompass viscosity, yield stress, and flow index assessments.^{[22] [23]}  

3. Laser-based 3D printing system

Selective laser sintering (SLS) is a laser-based technique that fuses powder materials by using a controlled laser beam to trace a pattern on the powder bed's surface. After forming an initial layer, a roller distributes an additional layer of powder over it. The object is assembled in a layered fashion, with each layer formed and retrieved from the powder bed below.^[24] The principle of SLS is that a high-energy laser selectively fuses powdered materials, typically polymers or ceramics, layer by layer based on a digital model, creating solid structures that adhere to the design.^[25] The SLS technique offers a high resolution of up to 0.2 mm for printed objects, compared to other techniques offering resolutions between 50 and 200 mm. The resolution and layer thickness of the printed object are determined by the intensity and exposure time of the laser beam. However, there are limited studies on SLS in 3D printing technology. This method uses lasers to elevate polymer temperature above their melting point, facilitating the hardening process, with the interaction between the laser beam and powder particles being crucial. SLS technology offers high-resolution printing and medication fabrication without solvents. However, high-energy lasers can cause drug degradation.^[26] Future research could develop polymers absorbing laser light for dosage forms and 3D printing of pharmaceuticals. Challenges include API degradation, limited photosensitive polymers, and limitations on producing hollow structures. Future research should focus on developing these alternatives.^[27]

Application of 3D-printed Oro-dispersible film

The study conducted by Juhyan Lee et.al assessed an orodispersible film formulated with aripiprazole, employing a combination of 3D printing techniques and hot-melt extrusion (HME) filament. The results indicated that the 3D-printed films demonstrated enhanced dissolution and disintegration rates relative to solvent-cast films, with hydroxypropyl cellulose (HPC) 3D-printed films achieving complete disintegration in 45 ± 3.5 seconds. Additionally, the dissolution rate of the HPC films reached 80% within a 30-minute timeframe at pH levels of 1.2 and 4.0 in the USP buffer. This study highlighted the critical role of film formation architectures in determining drug release profiles and suggested that mechanical uniformity could be specifically designed for each zone within a single dosage unit.^[28] Nunzio Denora et.al has pioneered a novel oral mucoadhesive film through the Direct Powder Extrusion (DPE) 3D printing technique, aimed at delivering Clobetasol propionate, a drug utilized in the paediatric treatment of Oral Lichen Planus (OLP), a rare chronic disorder. The film's chemical and physical characteristics were enhanced via partial amorphization during the printing phase and the establishment of a multi-component complex with cyclodextrins. The resulting mucoadhesive films exhibited significant mucous adhesive characteristics, a resilient and elastic structure, and notable drug retention within the epithelial layer, thereby preventing systemic absorption. These attributes suggest that DPE-printed films may be a suitable candidate for paediatric OLP therapy.^[29] The role of three-dimensional printing technology in the field of pharmaceutical technology is becoming increasingly significant due to its extensive range of applications. Researchers, including Witold Jamroz and his team, examined the synergy between fused deposition modeling and the creation of orodispersible films that incorporate poorly soluble substances like aripiprazole. They demonstrated the effective use of pharmaceutical-grade PVA in the production of aripiprazole-loaded filaments for 3D printing. Their results confirmed that fused deposition modeling is a viable method for fabricating orodispersible films with consistent shapes and drug content. Additionally, the mechanical properties of the 3D printed films were comparable to those of cast films, with lower variability observed in the printed orodispersible films. This study underscores the potential of fused deposition modeling as an alternative technique for the preparation of orodispersible films, marking a significant advancement in the development of pharmaceutical dosage forms.^[30] The goal of this work to examine the applicability of mechanical extrusion-based printing of semisolid dispersions with in-process drying for the development of orally disintegrating films. This approach allows for the rapid preparation of ODFs, with the drug content being influenced by the model dimensions and volumetric concentration, thereby eliminating the need for air pressure adjustments or preliminary test prints. An optimized formulation was utilized for ODFs containing benzydamine hydrochloride, produced in various thicknesses. The physicochemical properties of the films were analyzed, revealing a strong correlation among model height, weight, thickness, disintegration time, and mechanical properties. Dose control was achievable by varying model thickness or drug concentration. The films demonstrated handleability and flexibility achieved.^[31] Jan Elbl's research successfully developed orodispersible films containing 30 mg of phenytoin through the application of 3D printing technology. The investigation involved testing various concentrations of HPMC E5 and HPMC E15 dispersions to identify the optimal concentration and viscosity suitable for a customized syringe extrusion 3D printer. The findings indicated that 20% w/v of HPMC E5 and 10% w/v of HPMC E15 were the most effective polymers for drug incorporation and printing processes. The phenytoin-loaded E15 orodispersible films exhibited favorable physical characteristics, robust mechanical strength, rapid disintegration (within 5 seconds), and swift drug release, highlighting the potential of HPMC E15 as a viable polymer for extrusion-based 3D printing and orodispersible film production. Future studies may focus on assessing film stability and personalizing orodispersible films for individual patients by modifying the printing volume.^[32] The researcher explored to formulation of ODFs for the oral administration of montelukast sodium, targeting the treatment of asthma and allergic rhinitis. The ODFs were successfully produced through three-dimensional (3D) printing techniques utilizing propylene glycol (PG), hydroxypropyl methylcellulose (HPMC), and polyethylene glycol 400 (PEG). Each film incorporated 5% montelukast sodium. A series of evaluations were conducted on the films, assessing parameters such as drug compatibility, mass uniformity, thickness, disintegration time, folding endurance, moisture absorption, pH, in vitro drug release, drug content, moisture loss, mechanical properties, and cellular toxicity. The findings indicated that all formulations disintegrated within 40 seconds, achieving over 98% drug release in just 2 minutes. This formulation demonstrated optimal drug content, characterized by its robustness and ease of transport. The Montelukast sodium ODFs presents a viable alternative to traditional dosage forms. Furthermore, the formulations exhibited no toxic effects in an in vitro cytotoxicity assessment using 3T3 cells.^[33]  The deficiency of age-appropriate pharmaceuticals for a variety of indications often necessitates dose adjustments, leading to potential inaccuracies in dosing. This investigation aimed to compare the existing protocol for creating personalized warfarin doses at HUS Pharmacy in Finland with two innovative printing methodologies. Dosage forms of differing strengths were developed through semisolid extrusion 3D printing, inkjet printing, and the traditional compounding technique for oral powders in unit dose sachets (OPSs). Warfarin-loaded orodispersible films were fabricated using hydroxypropyl cellulose as the film-forming agent. These ODFs exhibited desirable characteristics, being both thin and flexible. The printed ODFs showed superior drug content and disintegrated in 45 seconds, a significant improvement over orally disintegrating tablet (ODTs). All dosage forms proved stable during a one-month stability study and were suitable for nasogastric tube administration, thereby facilitating treatment for all patient groups in a hospital environment.^[34] In a related study, Ehtezazi et al. aimed to produce both single-layered and multilayered oral films through the FDM technique. The polymers selected for this investigation included polyethylene oxide (PEO) and polyvinyl alcohol (PVA), with paracetamol and ibuprofen as the model drugs. The researchers prepared filaments through the hot-melt extrusion technique, operating at temperatures of 60 °C for PEO and 130 °C for PVA. These filaments were then processed via 3D printing to create oral dissolvable films ODFs for both ibuprofen and paracetamol. Notably, the authors implemented taste-masking layers at a lower temperature of 130 °C to evaluate the acceptability of the ODFs, thereby enhancing patient compliance. The study observed that both ODFs had extended disintegration times, which may be linked to the high molecular weight of the polymers used. ^[35]

 

 

 

 

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Future Perspective and Challenges

Orodispersible drug carriers present a significant opportunity to enhance medication adherence and therapeutic outcomes for a wide range of patients. The literature consistently emphasizes that the beneficial attributes of orally disintegrating dosage forms, including rapid disintegration, no need for water, small size, and effective taste-masking, make them an optimal choice for the paediatric demographic. There remains a considerable lack of commercially available orally disintegrating medicinal products tailored for minors, which poses a significant challenge to the global implementation and acceptance of this dosage form. Nowadays, drug administration via oral methods have several disadvantages, including a lack of both chemical and physical stability, degradation of drugs, GI obstacles, the absorption rate, dissolution, and permeability. In addition, scientists and researchers are constantly trying to invent new delivery strategies capable of enhancing these oral dosage forms by improving their administration, compliance, convenience, and active drug integrity, and reducing side-effects, thus providing them with the potential to cater to the broader paediatric population.^[36] The capacity to customize a dosage may allow for its optimization by taking into account characteristics such as gender, age, weight, health condition, required size, release qualities, the amount of use/treatment time, and shape. Any type of dosage form, from dissolving tablets, capsules, film to any form, might be designed, and customised using 3D printing for any ailment.^[37] An orodispersible antibiotic delivery system could be especially beneficial, as antibiotic suspensions are among the limited oral options available Infants who are unable to consume or chew medications. Several researches are currently starting to explore the possibility of orally dispersible antibiotic formulations, including levofloxacin and ciprofloxacin. Consequently, it is essential for future research and development to focus on the optimal design of commonly utilized drug classes into intelligent orally disintegrating matrices specifically tailored for paediatric pharmacotherapy.^[38] With improvements in the latest wave of 3DP technologies, the growing popularity of artificial intelligence (AI), and an evolving in treatment regimens toward individualized therapy, ODFs may be important dosage forms that combine all three features. There are significant hurdles to the effective manufacturing and greatest efficiency of orally disintegrating medication delivery systems that necessitate further investigation and improvements. As previously indicated, these systems are characterized by a limited capacity for drug loading, which can be particularly problematic for pharmaceuticals that require substantial doses to produce the desired pharmacological effects.^[39] Moreover, the implementation of taste-masking strategies is vital for these dosage forms to ensure they are well-received by paediatric patients and their families. Additionally, the brittle and hygroscopic properties of many orally dissolving medicaments are frequently necessitating the use of customized foil packaging and specific stability requirements, which are generally costlier than conventional packaging options. As a result, there is a pressing need for further in-depth research to address these formulation challenges and optimize this category of delivery systems, particularly for widespread application in children and adolescents.^[40] Because of the beginning phases of oro-dispersible film investigation and the intricate nature of the technique of 3D printing, acquiring accurate statistical information on the positive and negative aspects can be difficult. Researchers actively explore and refine these techniques, but extensive quantitative data may not be readily available.^[41] Regulation the use of 3D printing devices for manufacturing solid oral medication forms could be complicated. For example, depending on where the printer is positioned such as a clinical trial site, a specialty production facility, or an intensive care unit, the drug product may need to be classified under each of these regulatory paths. The control of quality of the final drug product must also be examined. In addition, all aspects of the printing process would need thorough evaluation to ensure consistent product quality from the hardware, raw material suppliers, operator training and quality control.^[42] Pharmacists were among the first to understand the full significance of the use of 3D printing for the manufacture of drugs. Using the 3D printer, the pharmacist will synthesize and construct unique formulations based on the requirements of individual patients with the condition. The pharmacy staff, as drug experts, can recommend the most suitable strategy and determine when the 3D printer might be applied in pharmaceutical applications. ^[43]

Regulatory Perspective

The lack of a regulatory authority is a major hurdle to using this method of production to manufacture pharmaceutical formulations. Although no Good Manufacturing Practice (GMP) criteria for 3D-printed medications have been officially published, the FDA did establish rules for three-dimensional medical device products in 2017. Unfortunately, no governing body has yet established recommendations for the manufacture of 3DP dosage forms. Moreover, it is uncertain whether regulatory approval will be needed only for the finished product or for the regulations that govern all levels of product design and manufacture. ^{[44] [45]} Pharmacopoeias do not contain methods of analysis for tablets produced by 3DP and the existing methods for the other pharmaceutical oral solid dosage forms are difficult to apply to discover regulatory issues in the printing process of pharmaceutical formulations, a concrete regulatory requirement for printable products is urgently needed. ^[46] The worldwide medicine limited availability caused by the COVID-19 epidemic contributed to the rapid expansion of 3D printing in the pharmaceutical sector. This growth is being fueled by the emergence of new industry players, as well as the release of new 3D printers, materials and start-up funding.^[47] Furthermore, the basic purpose of both European Union and United States legislation is the same: to enhance the health of children through scientific advances and to offer a structure for evaluating effectiveness as well as safety in the paediatric population. The main impact of this rule was the establishment of the Paediatric Committee (PDCO). Its primary function was to offer objective scientific perspectives on paediatric investigation plans (PIPs) and to establish strategies for paediatric pharmaceuticals. The use of oral thin films is projected to help enhance adherence and treatment results in paediatric and elderly individuals. This will be driven in part by the new regulatory requirements for these vulnerable patient groups to be taken into consideration from the point of drug discovery and development rather than the conventional reformulation and titration from normal adult dosage forms.^[48] Although the EMA and US FDA have recently provided guidelines for industry, especially in development of formulations for vulnerable patient groups such as paediatric and geriatric populations, more research is required to establish global standards since most of the reported studies vary greatly in the methodology and approaches, and it is difficult to tell which is appropriate.^[49] However, it has been reported that the FDA encourage the development of complex dosage forms and manufacturing processes using science and risk-based approached which may pave the way for 3D printing.^[42]

CONCLUSION

A prominent class of oral drug delivery systems that overcomes the difficulties associated with most oral formulations in paediatric patients is the orally dissolving medicament. This innovative dosage as an oro-dispersible film for rapidly-dissolving drug delivery system. This method improves patient adherence by administering drugs to their site of action quicker and more efficiently, with instant breakdown dissolution, as well and administration, removing the requirement for the patient to swallow and chew. Furthermore, advancements in technology, particularly in the area of 3D printing, are contributing to the development of personalized medicines, which could be essential for future healthcare practices. The investigation of fixed-dose combination products is critical for understanding their role in enhancing patient adherence, as they simplify medication regimens by decreasing the frequency of doses and minimizing the overall pill burden. The rapid advancement of 3-D printing technologies in the healthcare sector has an opportunity for transforming methods of manufacture away from traditional mass-production and toward personalized, on-demand dosage forms. This transition might result in more secure and efficient drugs for patients. The impact of this technology on conventional pharmacy practices is essential for the modern healthcare system. This approach promotes the advancement of affordable, accessible, and personalized dosage forms that achieve the desired drug release profiles, meeting the needs of individual patients or specific populations. It significantly accelerates the manufacturing process while enhancing cost-effectiveness. Consequently, substantial and beneficial transformations in conventional drug formulation and manufacturing practices are anticipated, leading to the emergence of relevant regulatory frameworks and industrial applications

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