1Department of Quality Assurance, NMIM'S School of Pharmacy and Technology Management, Shirpur, India.
2M.S., Ph. D. Areas of Specialization Computer-aided drug design, Molecular dynamics, QSAR, NMIM'S School of Pharmacy and Technology Management, Shirpur, India.
3Department of Pharmacognosy, R.C. Patel Institute of Pharmaceutical Education & Research Shirpur, India.
4Department of Pharmacology, R.C. Patel Institute of Pharmaceutical Education & Research Shirpur, India.
5Department of Quality Assurance, Ahinsa Institute Pharmacy Dondaicha, Shindkheda, India.
The ability of some heart, gastrointestinal, and infection medications to be absorbed in the body has been shown to improve significantly when using gastro-retentive dosage forms (GRDF). Because of their limited absorption windows, pharmaceutical experts usually find it difficult to develop the bioavailability of these medications at a clinically effective dosage strength. Nevertheless, these medications have a brief biological half-life, and formulations with quick release don't deliver drug levels within the therapeutic range. In addition, the need for multiple doses of the existing formulations is associated with potential non-compliance issues. The goal of prolonging the residence time of the dosage form in the stomach can be achieved with systems that are too large to pass through the opening to the small intestine when compared to single-unit and rapidly dissolving formulations. The systems are mostly known as gastro-retentive systems, and such an approach can significantly prolong the pharmacokinetics of certain drugs, resulting in an improvement in the efficacy profile and better patient compliance, leading to more effective treatment outcomes. Recent advancements in 3D printing technology, such as semisolid extrusion-based 3D printers, have the potential to bid adieu to the variations seen in the obtained gastro-retentive drug delivery systems. Furthermore, the proteins used in the present dosage form are not exposed to UV or other environmental agents, which increases the shelf life of the active moiety used. Additionally, dose segmentation is one of the special niche facilities of this dosage form. Moreover, the 3D printed dosage form is quite systematized when compared to the traditional compression method. The pharmaceutical prerequisites of building a 3D printed system, the secured accomplishment of Eudragit L100 in the stomach, various components used in the system, manufactured satellite system, method of loading the model drugs, adjuvant in drug entrapment, and other characteristics of the dosage forms are also discussed. This review discusses the unmet need in the delivery of various drugs that could be a practical tool in developing novel gastro-retentive drug products and research studies on 3D printing technology toward designing unified GRDF to potentiate the bioavailability and pharmacokinetics. Furthermore, it is important to decide the design structure of devices using the 3D printing method, which can depend on performance, portability, and comfort.
There is a noticeable and increasing interest in exploring alternate delivery methods to attain more effective local therapies because of the numerous drawbacks that are commonly associated with surgical procedures and the parenteral administration of various medications. In recent years, the development of gastro-retentive drug delivery systems has seen a notable increase, aiming to extend the gastrointestinal residence time of administered drugs. This extension is crucial as it helps to significantly enhance their bioavailability, which ultimately leads to improved therapeutic efficacy and outcomes for patients. While there are some established traditional gastro-retentive drug delivery systems currently in use, including floating systems and mucoadhesive formulations, it’s vital to recognize that they are not without limitations. These limitations can potentially affect the overall performance of such systems, bringing about challenges that need to be addressed. This comprehensive review intends to present and analyze the most recent advances within this dynamic field of study, emphasizing the exciting use of novel dosage forms. Additionally, the innovative application of 3D printing technology and other state-of-the-art methods aimed at developing gastro-retentive drug delivery systems will be thoroughly discussed. Furthermore, the review will include a thorough report on both in vitro and in vivo performance of these advanced systems, providing valuable and insightful information regarding their effectiveness, as well as their prospective applications in clinical settings. (Das et al., 2021) (Dhiman et al.2023) (Dey et al.2024) (Waqar et al.2024) (Raja et al.2023) (Raj mane et al.2022). Poor patient compliance, drug degradation and elimination, as well as variation in bioavailability are all significant challenges that lead to reduced effectiveness of oral medication. These issues can frequently result in suboptimal therapeutic outcomes, leaving both patients and healthcare providers feeling frustrated due to the unpredictable responses to treatment that often occur. As an innovative alternative to traditional approaches, gastro-retentive drug delivery systems have emerged, which are capable of markedly increasing the residence time in the stomach. This extended retention in the gastric environment is achieved due to their specific properties, which include not only heightened density but also larger diameter, along with unique bioadhesive or bioresponsive characteristics that contribute to their effectiveness. Such advanced systems can effectively prevent the myriad problems related to variable emptying times and overall gastrointestinal transit, thereby enhancing pharmacokinetics. This enhancement leads to a more reliable and consistent therapeutic effect, essential for achieving desired health outcomes. As a result, these significant improvements in drug delivery methods may contribute to better patient adherence to prescribed therapies and ultimately improved overall patient outcomes in clinical settings. (Dey et al.2024)(Kumar et al.2021)(Desai et al.)(Maurya et al.)
Gastro-Retentive Drug Delivery Systems (GRDDS)
Introduction:
Gastro-Retentive Drug Delivery Systems (GRDDS) It has always been a considerable challenge to develop novel drug delivery systems that are capable of maintaining the drug concentration within a therapeutic window for a specific and sustained period while simultaneously ensuring proper absorption of the drug at a relevant site within the body. Gastro-retentive drug delivery systems (GRDDS), which specifically refer to those systems designed to keep the drugs retained in the stomach for an extensive duration, have been developed to effectively address the unique physiological challenges that the stomach presents as a drug absorption site. The underlying reason why a GRDDS is categorized as a mouth-to-stomach targeted delivery system is primarily due to the stomach’s capability of exhibiting a consistent rhythmic motion coupled with a relatively uniform environment. Typically, GRDDS are intended to facilitate local therapeutic effects within the stomach or an extended systemic effect where the stomach acts as the primary site of absorption for the administered drug. The notion of developing gastro-retentive drug delivery systems has gradually emerged over the past decade as a focal point in pharmaceutical research and development. In fact, the study and marketing of gastro-retentive drugs have been topics of interest for a lengthier duration, with various innovations being pursued. Traditional approaches largely concentrate on methodologies such as expanding, floating, sinking or adhesion strategies to enhance the efficacy and functionality of GRDDS. These involve techniques including floating systems, low-density floating formulations, high-density floating designs, plastic stomach floating systems, hydrodynamically balanced systems, and floating graft systems among other. The recent advancements in technology have notably shifted the focus of GRDDS toward two major subtypes: floating-subtype GRDDS and fluid-subtype GRDDS. The former class represents a typical GRDDS, characterized predominantly by a straightforward preparation process, fewer excipients involved, and has been extensively studied and developed over time. However, there are notable limitations concerning the occurrence of slower transit times, the influence of varied pH levels, high meals fed, and the challenges associated with smaller tablet sizes, which can restrict broader application. Extensive efforts have been devoted to optimizing and preparing floating-subtype GRDDS, with the incorporation of greases, resins, CO2-generating agents, and other low-density excipients frequently utilized to enhance the density of the drugs utilized, all while gap preparation techniques enhance floating capabilities. The last decade has witnessed an explosive increase in the volume of published research relating to GRDDS, concomitant with a rapid surge in the development of pharmaceuticals aimed at overcoming the challenges that currently inhibit the successful oral delivery of various drugs and biological agents. At this juncture, GRDDS has been gaining increasing recognition as a versatile and highly promising strategy within the pharmaceutical industry. Their application and effective selection are critical precursors for personalized therapies that cater to individual patient needs. The potential ease of translating GRDDS into clinical practice ultimately renders these systems an advancement for delivering poorly water-soluble compounds, effectively expanding therapeutic windows, controlling aqueous or dissolution behaviors, and enabling localized therapy for specific infections, among various other applications. Additionally, the ongoing development of innovative 3D printing technologies, exemplified by methods such as fused-deposition modeling and semisolid extrusion 3D printing, has emerged as a predominant focus in the application of GRDDS advancements. This present review aims to provide valuable insight into the design, applications, limitations, and recent progress related to the development of novel gastro-retentive drug delivery systems, with particular emphasis on the rise of 3D printing technologies in this domain. The significance of GRDDS, along with the pivotal role of 3D printing technologies will be discussed thoroughly at the onset of this exploration. (Dhiman et al.2023) (Das et al., 2021) (Rajmane et al.2022)
3D Printing in Pharmaceuticals-
In the realm of the pharmaceutical industry, the traditional techniques that have been utilized for tablet manufacturing have been in place for many decades. Over the years, these conventional methods have served as the backbone of pharmaceutical production. However, as technology has advanced, innovative and modern methodologies, such as 3D printing, have emerged and revolutionized the field. This cutting-edge technology not only facilitates the design but also the creation of personalized dosage forms that exhibit both geometric simplicity and exceptional tailored characteristics. Moreover, it is capable of producing controlled drug-release profiles that can cater to individual patient needs and specific treatment protocols. Among the various 3D printing techniques, fused deposition modeling and selective laser sintering stand out as particularly effective approaches for producing tablets tailored for individual users. These methods enable pharmaceutical manufacturers to create tablets with precise specifications that were previously unattainable. Furthermore, noteworthy advancements have been made with the production of tablets that possess specific release mechanisms tailored to accommodate different types of drugs. These innovations have been accomplished through experimentation with a blend of inactive pharmaceutical ingredients designed to enhance oral drug delivery, particularly in cases related to inflammation, microbial infections, and the treatment of substance abuse disorders. In particular, research has indicated that combined formulations have the capability to achieve zero-order release profiles, which is highly beneficial for maintaining consistent drug levels in the body over extended periods. As a result, the integration of 3D printing technology in pharmaceutical production holds significant promise for substantially enhancing the accessibility and effectiveness of pharmaceutical treatments across the medical landscape. Three-dimensional (3D) printing has been undeniably established as a viable and transformative manufacturing technique within the pharmaceutical sector. It has been effectively utilized for both personalized structures that cater to unique patient needs and for the mass production of commercial products that meet market demands. The remarkable capability of 3D printing to fabricate personalized dosage forms opens up a vital avenue for producing patient-specific designs, which directly leads to more effective and targeted treatments. With the advanced techniques available through 3D printing, drug manufacturers now hold the ability to engineer dosage forms that not only convey the desired drug release characteristics for each specific drug but also support the creative simplicity of design. State-of-the-art technologies, including fused deposition modeling, stereolithography, inkjet printing, selective laser sintering, and various others, have been seamlessly implemented in conjunction with inactive pharmaceutical ingredients. This integration allows for the fulfillment of numerous properties that are essential and specific to various categories of drugs, including crucial factors like bioavailability, precise dose requirements, and optimal drug release patterns. The continual evolution of these methods will ultimately lead to a more personalized approach in medicine, significantly improving patient care and enhancing therapeutic outcomes across the board. (Vaz & Kumar, 2021) (Desu et al.2021) (Ullah et al.2023)(Arya et al.2023)(Andreadis et al.2022)(Gerb and Anggil2024)(Ahmad et al.2023)(Pathak et al.2023)(Varghese et al., 2022)(Soni2024)
3D Printing Technologies for Gastro-Retentive Tablets-
Gastro-retentive delivery represents a highly promising approach for significantly enhancing the therapeutic efficacy of numerous categories of pharmaceutical agents. However, the current availability of innovative and patient-friendly manufacturing technologies specifically designed for the fabrication of gastro-retentive dosage forms remains quite limited. In this context, 3D printing has emerged as a rising star in the pharmaceutical field, providing an exciting opportunity for on-demand manufacturing, which can be conducted within hospitals or at small-scale facilities. This flexibility allows for the rapid production of tablets endowed with a variety of unique properties tailored to meet individual patient needs. An overview of the current drug delivery platforms will be presented, placing a distinct emphasis on the various approaches that have been developed utilizing 3D printing technologies to effectively extend gastric retention time. This overview will encompass a range of strategies, including floating drug delivery systems, muco-adhesive systems, expandable dosage forms, as well as inflatable systems. Moreover, the discussion will delve into their potential applications, particularly concerning high-dose delivery, pulsatile release mechanisms, and multi-drug release options, which can offer substantial therapeutic benefits. In summary, the innovative techniques of 3D printing for gastro-retentive drug delivery methods provide a versatile and intelligent platform that facilitates the precise design, synthesis, and in situ production of customized dosage forms. These forms carry multiple therapeutic potentials which, if fully realized, could revolutionize the landscape of the future pharmaceutical field. The implications of these advancements for patient care and medication adherence are significant, making the continual exploration and expansion of such technologies a priority for researchers and healthcare professionals alike. (Das et al., 2021)(Dhiman et al.2023)(Raja et al.2023)(Dey et al.2024)(Kumar et al.2021)(Rajmane et al.2022)(Shah et al., 2025) Gastrointestinal (GI) incompetence and the degradation of pharmaceutical agents within the stomach represent significant obstacles for effective oral drug delivery. The short gastric residence time that is observed in both fasted and fed state patients, along with the variable absorption of drugs that takes place from the distal regions of the GI tract, may ultimately lead to the suboptimal bioavailability of various acidic and basic drugs. To address these challenges, the technology of gastro-retentive drug delivery was developed with the specific goal of overcoming these limitations that hinder the efficacy of oral medications. Gastro-retentive drug delivery systems are designed to encapsulate a large dosage of drugs while simultaneously maintaining the therapeutic drug levels over an extended period within the stomach environment. The fundamental principles utilized for the fabrication of gastro-retentive dosage forms include a variety of methods such as diffusion, floating, expandable, swelling, muco-adhesive, magnetic, and density or plug mechanisms. Numerous strategies have been developed to successfully extend the gastric residence time of tablets, thereby enhancing their efficacy. Nevertheless, to date, there remains a limited number of approaches that are capable of fabricating drug delivery systems directly at the point of care, tailored specifically to meet the unique needs of individual patients. This highlights the ongoing challenge in the field of pharmaceutical sciences for creating more effective, personalized drug delivery solutions that can optimize therapeutic outcomes. (Das et al., 2021) (Dhiman et al.2023) (Rajmane et al.2022)
Materials Used in 3D Printing of Gastro-Retentive Tablets-
Numerous materials are utilized in the innovative process of 3D printing gastro-retentive (GR) tablets, which primarily consist of various polymers. Among the most widely utilized materials in this domain are polyethylene oxides, polyvinyl alcohol, polyethylene glycol, hydroxypropyl methylcellulose, and carboxymethyl cellulose. These substances serve as essential thickeners and binders specifically in 3D printing applications. Their suitability and effectiveness extend to an array of products, including pharmaceuticals, due to their remarkable tolerability, wide availability, economic feasibility, and excellent physiological properties. Additionally, the biodegradability of these materials makes them even more appealing for use in medical applications. In certain instances, biopolymers like chitosan and gelatin are incorporated into 3D printing, showcasing their unique properties that enhance the overall performance of the printed tablets. In addition to biopolymers, synthetic polymers find their place in this field, most notably polycaprolactone and polylactic acid. Polylactic acid has garnered considerable attention in recent years, largely due to its impressive availability, inherent biodegradability, and advantageous mechanical characteristics. However, it is noteworthy that if the lactide accumulation level or content within the material exceeds 5%, there can be a detrimental impact on the drug’s potency, which is a critical factor to consider during formulation. Polycaprolactone stands out as another significant polymer frequently employed in this manufacturing technique. PCL is particularly valued for its biodegradability, excellent mechanical strength qualities, and ability to withstand the test of time effectively. Furthermore, the range of materials employed in the 3D printing of gastro-retentive tablets encompasses various hydrogels, including HEMA, PEGDA, pluronic, alginate, and gellan gum, which represent the most frequently used materials within this specialized area. The hydrophilic nature of these hydrogels, coupled with their capacity for swelling, leads us to believe that they may provide significant advantages in oral drug delivery systems, enhancing the therapeutic efficacy of the administered medications. The ongoing exploration and development within this field continually showcase the potential for innovative solutions in drug formulation and delivery. (Turac et al.2024)(Yan et al.2024)(Alqahtani et al., 2023)(Vaishnav et al., 2024)(Mora-Castaño et al.2024)(Khizer et al.2023)(Abdul Khaleq & Ghareeb, 2022)(Dhiman et al.2023) In addition to the various types of polymers mentioned earlier, there exists another significant type of polymer that is composed of iron. This iron-based polymer is sporadically utilized in the production of GR cavities specifically with the intent to enhance drug absorption within the stomach environment. The unique characteristics of these iron particles enable them to effectively bind the tablet to the stomach lining, which consequently leads to an increase in the floating duration of the tablet in the gastric contents. However, it is essential to note that the inclusion of iron particles may potentially compromise the tablet's overall integrity, raising questions regarding the stability of the tablet after it has undergone the washing process. This concern arises because any damage to the tablet could impact its effectiveness. To mitigate the risk of altering the essential physical and chemical properties of the active pharmaceutical ingredient, this particular component has increasingly attracted specific attention from researchers. Moreover, the challenge presented by the hydrophobic regions that contribute to poor solubilization in gastrointestinal fluids may be effectively addressed with the aid of suitable polyethylene glycol (PEG) formulations. Furthermore, the introduction of microcrystalline cellulose serves a dual purpose. As a binder in the 3D model, it possesses the potential to optimize the anchoring capabilities of the tablet, while concurrently providing the GR tablet with the necessary mechanical resilience required for consistent performance in the challenging conditions of the gastrointestinal tract. (Rout et al.2024)(Bossmann et al.2022)(Zhang et al.2022)(Chen et al.2023)(G?sior et al., 2021)(Chan et al., 2022)(Udaipuria & Bhattacharya, 2025)(Ren et al.2024)
Design and Fabrication Strategies-
In recent years, 3D printing technology has garnered considerable attention as a highly promising pharmaceutical manufacturing method due to its remarkable potential to generate drug products that feature complex geometries and customized dosages tailored to individual patient needs. Encouraged by the early successes observed in a wide variety of dosage forms, researchers and manufacturers have proposed the use of 3D printed gastro-retentive devices as innovative solutions for achieving prolonged residence time in the stomach. This impressive capability associated with this new dosage form has been recognized for its ability to successfully overcome various physiological barriers, thus highlighting its strong potential for effective hollow organ-localized drug delivery—particularly for the treatment of various stomach-related diseases that require a targeted approach. Moreover, gastro-retentive (GR) devices hold the promise of promoting the efficient absorption of essential nutrients by significantly extending the opportunities for contact with the stomach wall. This noteworthy feature can be creatively leveraged for the synchronized delivery of therapeutic agents, even those with different pharmacokinetics, thereby enhancing the therapeutic outcomes. Additionally, it could serve as a vital solution for specific target groups suffering from malnutrition, particularly those whose ingestion and digestion of food cannot be achieved in a sufficiently short time frame. Such innovative applications of the GR platform are anticipated to revolutionize the present-day practices associated with oral medication administration, ultimately creating not only enhanced convenience for patients but also improved therapeutic efficacy. This paradigm shift in pharmaceutical technology could pave the way for more effective treatment regimens and better health outcomes for a wide array of patients. (Alqahtani et al., 2023)(Mau et al.2021)(Yan et al.2024)(Turac et al.2024)(Mora-Castaño et al.2024)(Oladeji et al.2022)(Hsu et al.2024)(Uboldi et al.2022). For drug products that are specifically designed to achieve the desired therapeutic effect related to a prolonged stomach residence time, promising innovations in pH-responsive polymers have now emerged, demonstrating superior control over the erosion process within an in vivo environment; consequently, the drug release profile can also be modulated with greater precision. When configuring the targeted Gastro-retentive (GR) structure, the primary objective is to effectively house both the drug-loaded chamber and the buoyant system within the GR device, ensuring that it remains easy to swallow and also maintains buoyancy to keep the upper part of the GR components floating in gastric fluids. Furthermore, the structural integrity of the device must be preserved to facilitate a gradual and controlled degradation process that occurs linearly at a slower pace. In 2010, regulatory authorities clearly defined the GR dosage form as tablets that have a density of less than 1.00 g/cm³. Due to this specific single-density requirement, the GR tablets currently available on the market are limited to accommodating only a fixed drug dose, which presents considerable challenges for clinicians trying to adjust the dosing to fulfill the varying needs of patients, particularly for those in pediatric and geriatric populations where dosage flexibility is critical for effective treatment outcomes. (Al-Majed, 2022) (Katakam et al., 2024) (Steffens, 2021) (Tsolaki et al.) (Majhi et al., 2022) (Tumuluru, 2021) (Dash & Singh, 2023)(Paavilainen)(Ene et al., 2024)
Advantages of 3D Printing for the Gastro-Retentive Table-
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3D printing, which is also commonly referred to as fused deposition modeling or fused-filament fabrication, stands out as an emerging and innovative additive manufacturing technology that is designed specifically to fabricate complete objects with remarkable precision, layer by layer. As this technology continues to evolve, its applications across various sectors demonstrate that 3D printing has significantly advanced from the initial stages of prototyping to the realm of personalized manufacturing, catering to specific needs and individual preferences. In particular, within the pharmaceutical industry, and more specifically within the specialized and niche field of drug product development, 3D printing has exhibited substantial potential for creating tailor-made or superior oral drug delivery systems. These systems allow for the adjustment of variable drug dosages, tailored release rates, and the combination of various drugs all within a single dosage unit. Furthermore, the advent of modern 3D printing technology unveils exciting new opportunities for a more rational, thoughtful design of dosage forms. These forms can be specifically tailored for effective drug delivery to distinct patient groups, which can include the pediatric population as well as the geriatric population. This is of critical importance, especially considering that it has been reported that oral dosage forms featuring modified release properties often remain underdeveloped and pose significant challenges in their development process. The capability of 3D printing to address these issues marks a significant leap forward, offering innovative solutions that can better meet the unique needs of patients across varying age groups and medical conditions. (Wang et al.2021) (Kutlehria et al.2022)(Gao et al., 2021)(Awad et al., 2021)(Hosny et al.2021)(Willemen et al.2022)(Pavan Kalyan & Kumar, 2022)(Naghib et al.2024)(Chakka & Chede, 2023)(Saberian et al.2024). The remarkable ability to merge a variety of different materials for both multi-active and multi-functional purposes, along with the finely controlled three-dimensional structure of the designed product, presents the 3D printed oral dosage forms as a truly unprecedented opportunity for future advancements in drug product development. The incorporation of advanced computerized design technology facilitates not only the customization but also the optimization of gastro-retentive strategies specifically tailored for individual drugs, allowing for a more personalized approach. Additionally, it enables the design of intricate drug release behaviors, which can include the anticipated pharmacokinetics that are essential for effective drug delivery. This level of flexibility and freedom in the design of composition and geometry presents significant challenges to traditional solid pharmaceutical processing technologies, which may not easily adapt to such innovative methods. The potential of these advanced technologies has been carefully specified and strongly emphasized within an evolving drug product quality system. This system is designed to facilitate innovation and enable technological advances in the fields of manufacturing and product design, as well as comprehensive product surveillance throughout the entire lifecycle of the product. Moreover, in cases where it is applicable, this system also extends into patient care. This approach prominently supports the overarching vision of the Quality by Design concept, which proposes that enhanced therapeutic efficacy and pharmaceutical quality can be achieved by meticulously controlling drug product performance through thoughtful and deliberate design. (Trivedi et al.2024)(Majrashi et al.2024)(Soni2024)(Nizam et al., 2024)(Pathak et al.2023)(Mohapatra et al., 2022)(Pandey & Gupta, 2024)(Kumar et al., 2024)(Saxena & Malviya, 2023)(Muhindo et al.2023)
Challenges and Limitations-
The incorporation of hot-melt extrusion in 3D printing technology is proving to be an exceptionally promising and highly industrially feasible technique for the effective and efficient manufacture of gastro-retentive (GR) tablets. This innovative and cutting-edge approach to 3D printing illustrates significant potential to swiftly optimize a wide range of various formulations while also facilitating the customized and tailored fabrication of personalized medicines. Furthermore, it has the remarkable capacity to deliver medications and systems precisely when they are needed, particularly in higher-resource settings where such groundbreaking innovations can make a substantial impact on healthcare delivery. Therefore, it becomes absolutely crucial to continue advancing these groundbreaking and revolutionary techniques with a strong emphasis on developing alternative gastro-retentive systems that are specifically aimed at achieving better patient outcomes and significantly enhancing therapeutic effectiveness for those in need. Although recent studies effectively exemplify the impressive versatility and substantial potential that 3D printing holds in the intricate process of designing and fabricating gastro-retentive tablets, it is important to recognize that much more remains to be discovered, thoroughly investigated, and carefully explored in this exciting and rapidly evolving area of research and application. The future looks incredibly bright for these transformative technologies as they continue to evolve and mature, with the promise of not only improving patient care but also revolutionizing the pharmaceutical industry at large, fostering a new era of healthcare solutions tailored to the diverse needs of individuals. (Oladeji et al.2022)(Alshammari et al.2024)(Dumpa, 2021)(Dos Santos et al., 2021)(Al Shawakri, 2022)(Turac et al.2024)(Zhao et al.2022)(Deshkar et al.2021). Despite the innovative techniques employed and utilized to fabricate the GR tablets, it remains critically important to address not only the preformulation aspects but also the various polymer properties of the polymer-based GR tablets. These properties include crucial factors such as the mechanical and rheological properties, polymorphism, density, water penetration time, mass variation, friability, disintegration time, and the tendency of tablet warping. Each of these factors plays a significant role in ensuring good reproducibility during the intricacies of the 3D printing process, and they directly contribute to ensuring the desirable performance of the tablets once they are produced. The recent advancements and implementation of various pharmaceutical dosage forms derived using 3D extrusion-based technologies have provided patients with a truly unique experience in the design and customization of dosage forms, largely due to the rapid release features exhibited by the drugs. It is of particular note that while current 3D extrusion-based pharmaceutics present significant opportunities, they still face a myriad of challenges and limitations, particularly in the realms of regulatory control and testing of pharmaceutical materials. Additionally, the manufacturing and production processes are not without their difficulties. Currently, there are limited bench-top techniques available that possess the capability to effectively handle large biomaterials suitable for printing, given the existing constraints related to time, temperature, and pressure. It is anticipated that such constraints can be effectively mitigated through continuous innovation in the development of new machines and modified materials designed explicitly for these applications. (Waqar et al.2024)(Zhang et al.2021)(Osma?ek et al.2021)(Nyamweya, 2021)(Kida et al.2021)(Mori et al.2024)(Shukla et al.2022)(Farhaj et al.2022)(Siafaka et al.2023)
Future Perspectives and Emerging Trends-
This article provides a concise perspective along with a forward-looking outlook on the diverse applications and innovative advancements in the field of 3D printing, specifically focusing on physico-chemically diverse gastro-retentive pharmaceutical solid dosage forms (GRSDFs). These sophisticated advancements are crucial for achieving finely tuned drug release profiles and enhancing the bioavailability of therapeutics that are administered orally. The text highlights that various 3D printing technologies, including 3D extrusion, inkjet printing, and laser-based printing, or combinations thereof, significantly enable a high degree of design flexibility for drug-loaded gastro-retentive solid dosage forms. This flexibility is not only essential for creating tailored drug release characteristics that can meet sophisticated and individual treatment needs but also for the functionalized administration of a variety of diverse drugs. These drugs may include antivirals, antibiotics, anticancer agents, probiotics, and protein biopharmaceuticals, and may even extend to applications such as in vitro antimicrobial drug release testing. The design and development of GRSDFs confront a range of challenging problems. Among these are issues such as incomplete drug inclusion or inadequate attachment of the active pharmaceutical ingredients. Other challenges include the mismatching of the density of the filled powder, which can lead to complications in the printing process, as well as difficulties related to powder tilting and inconsistent flowing within the printing equipment. Furthermore, there are concerns regarding density gradients, the trapping of air within the printed forms, and issues related to low liquid spreading that may impede quality. High hydrostatic pressure within slurry-based approaches can also pose significant obstacles. Additionally, achieving good adhesion between successive layers during the printing process is critical for structural integrity and the consideration of buoyancy control mechanisms, which can be simple or steerable, to ensure proper functionality of the dosage forms. Looking forward, future developments in 3D printing for GRSDFs will undoubtedly take into account the multifaceted research challenges that lie ahead. These challenges are essential as researchers and scientists strive to translate the innovative technology of 3D gastro-retentive printing from the confines of laboratory settings into real-world, economically viable production scenarios. This transition is crucial for wide spread adoption and effectiveness in clinical settings. The exploration of these advancements opens exciting prospects that promise to enhance patient care and therapeutic efficacy in the realm of oral drug delivery systems.
CONCLUSION-
In conclusion, the remarkable versatility and inherent simplicity of 3D printing technology are rapidly revolutionizing the intricate design and progressive development of medical devices specifically tailored for personalized therapy, meticulously adapted to meet the individual needs of each patient. Furthermore, this advancing technology significantly streamlines and simplifies the complexities that are typically associated with the fabrication of gastro-retentive (GR) tablets. It effectively prolongs the gastro-retentive time (GRT), which would otherwise require a tedious process involving multiple intricate and convoluted steps, as well as considerable effort from highly skilled professionals in the field. Elastic Systems has been identified as an especially intriguing group of gastro-retentive polymers, which are recognized for their unique ability to leverage the desirable physicochemical properties that are absolutely essential in the development and formulation of Fused Deposition Modeling Gastro-retentive Tab lets (FDM-GRTs). These innovative formulations represent a groundbreaking new class of integrated gastro-retentive tablets, specifically designed for advanced and enhanced performance. These tablets not only significantly enhance GRT but also satisfy unique pharmacotherapeutic objectives, which serve to greatly improve the overall efficacy and safety of the drug being administered to patients. The ongoing progression of gastro-retentive-controlled and sustained dose administration is of utmost importance in the context of the exponential development of modern high-potency medications, as well as less gastro-retentively optimized drugs, alongside potential expression sites that extend far beyond just the gastrointestinal tract. This development is opening new and exciting avenues for research and application in the medical field. This innovation possesses the remarkable capacity to exert a profound influence on disease management and treatment outcomes, leading to a truly transformative impact in the field of medical therapies while significantly improving the quality of life for patients all around the globe. (Mora-Castaño et al.2024)(Majrashi et al.2024)(Hatami et al.2024)(Kulkarni, 2023)(Muhindo et al.2023)(Seoane-Viaño et al.2021)(Singh et al.2023)(Paccione et al.2024)(Anwar-Fadzil et al.2022)
REFERENCES
Divya Jain*, Dr. Ranajit Shinde, Shital Patil, Krunal Mali, Hemant Mali, Revolutionizing Drug Delivery: 3D Printing of Gastro-Retentive Tablets for Enhanced Therapeutic Efficacy, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 5, 1933-1949 https://doi.org/10.5281/zenodo.15388189
10.5281/zenodo.15388189
