Solid Dosage Research Articles

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Voriconazole.

According to the ICH M9 Guideline, the triazole antifungal voriconazole is a Biopharmaceutics Classification System (BCS) class II drug, being highly soluble at the highest dose strength but not at the highest single dose. Although the ICH M9 allows for consideration of BCS-based biowaivers in such cases, voriconazole does not meet the additional requirement of dose proportional pharmacokinetics (PK) over the therapeutic dose range. By contrast, if the classification were based on the FDA solubility criteria that were in place prior to ICH M9 (based on the highest dose strength), voriconazole would belong to BCS class I and thus qualify for the BCS-based biowaiver. Since the highest oral dose strength of voriconazole dissolves very rapidly under all BCS conditions, and comparative in vitro dissolution of different tablet formulations aligns with the demonstration of BE in clinical studies, it seems that the ICH Guideline may be unnecessarily restrictive in the case of voriconazole. Therefore, this review discusses potential revisions of eligibility criteria and the extension of biowaiver approvals to encompass a wider range of appropriate drugs. Specifically, a classification system that is more relevant to in vivo conditions, the refined Developability Classification System (rDCS), coupled with biorelevant dissolution testing, may be more applicable to compounds like voriconazole.

Semi Solid Dosage from Ointments

Oinment are semisolid formulation commonly used topic administration active pharmacutical ingredient And theraputic uses of oinment in trating various Dermatological and systematic condition oinment are primarily composed base (such as petroleum lanolin or emulsifying wax ) the skin barrier for localized or systemic effect..

Graph Neural Networks with Multi-features for Predicting Cocrystals using APIs and Coformers Interactions.

Active pharmaceutical ingredients (APIs) have gained direct pharmaceutical interest, along with their in vitro properties, and thus utilized as auxiliary solid dosage forms upon FDA guidance and approval on pharmaceutical cocrystals when reacting with coformers, as a potential and attractive route for drug substance development. However, screening and selecting suitable and appropriate coformers that may potentially react with APIs to successfully form cocrystals is a time-consuming, inefficient, economically expensive, and labour-intensive task. In this study, we implemented GNNs to predict the formation of cocrystals using our introduced API-coformers relational graph data. We further compared our work with previous studies that implemented descriptor-based models (e.g., random forest, support vector machine, extreme gradient boosting, and artificial neural networks). All built graph-based models show compelling performance accuracies (i.e., 91.36, 94.60 and 95. 95% for GCN, GraphSAGE, and RGCN respectively). RGCN demonstrated effectiveness and prevailed among the built graph-based models due to its capability to capture intricate and learn nuanced relationships between entities such as non-ionic and non-covalent interactions or link information between APIs and coformers which are crucial for accurate predictions and representations. These capabilities allows the model to adeptly learn the topological structure inherent in the graph data.

Development of polymer-encapsulated microparticles of a lipophilic API-IL and its lipid based formulations for enhanced solubilisation

Active Pharmaceutical Ingredient-Ionic liquids (API-ILs) have the potential to improve the bioavailability of BCS Class IV Drugs. However, the problematic physical handling properties of room temperature API-ILs have impaired clinical and commercial exploitation to date. Lipid-based formulations (LBFs) are used to improve the absorption of drugs with limited bioavailability. Nonetheless, LBFs face limitations such as low drug loading capacity and sub-par physical stability. A platform for transforming API-ILs into solid forms at high loadings via spray encapsulation with polymers has been developed and previously demonstrated for hydrophilic API-ILs. The current work demonstrates that this platform technology can be applied to a lipophilic API-IL of the BCS Class IV API, chlorpromazine, and to multi-component solutions comprising API-IL and a LBF. Furthermore, solidification of a type IIIB, liquid LBF was achieved via spray encapsulation with cellulose- and methacrylate- based polymers for the first time. The spray-encapsulated formulations had excellent physical handling properties, and successfully eluted the API-IL in aqueous media. The chlorpromazine release profiles from the API-IL, the API-IL containing LBF, and the solidified formulations, were evaluated in vitro using phosphate buffer (pH 6.8) and fasted state simulated intestinal fluid (FaSSIF). Spray-encapsulated formulations exhibited improved release profiles compared to the liquid formulations. Overall, these findings indicate that phase-separated, polymeric, solid formulations of liquid API forms represent a promising platform technology for developing oral solid dosage forms of poorly bioavailable drugs.

Characterisation of a continuous blender: Impact of physical properties on mass holdup behaviour

Continuous blenders are a key unit operation in Continuous Direct Compaction, a route to solid oral dosage forms that is receiving significant interest. Mass holdup in these blenders is a crucial variable; understanding how it is influenced by material properties, equipment configuration and process settings is key. The present work evaluated a Gericke GCM-450 blender for range of outlet weir aperture geometries (angled or horizontal), material properties (pure components and blends) and process settings (throughput and impeller speed). Results show opposing mass holdup behaviour depending on weir choice, material density and flowability, likely linked to the propensity of the material to form an inclined powder surface that matches – or does not – the chosen weir geometry. The present work underscores the need for fundamental process phenomena understanding, especially when insight is sought for how blender performance varies across multiple dimensions (throughput, impeller speed, material properties) and discrete equipment choices (weir geometry).

Mapping active pharmaceutical ingredients Distributions in tablets using Time-of-Flight secondary ion mass spectrometry with multivariate curve resolution

This study introduces an advanced approach to identifying signals associated with indapamide, amlodipine, and perindopril in solid dosage form using time-of-flight secondary ion mass spectrometry (ToF-SIMS) combined with multivariate curve resolution (MCR). The primary objective was to obtain and characterize these signals through MCR factors, which then led to identifying unique signals specific to each active pharmaceutical ingredient (API). These unique signals were crucial for constructing detailed 2D and 3D images of the API distribution within the tablet. The results demonstrated that indapamide and amlodipine exhibited multiple unique peaks, while perindopril had only one. Additionally, the study revealed non-homogeneous distribution patterns of APIs and excipients, such as SiO2 and Mg stearate. This work highlights the significance of applying advanced analytical techniques such as ToF-SIMS and MCR in the pharmaceutical field to ensure consistent therapeutic efficacy through a better understanding of API distribution.

Production sustained release dosage forms from deliquescent substances by solid dispersion systems

Introduction. The production of solid dosage forms from hygroscopic substances is a complex technological task. The addition of hygroscopic substances into a polymer matrix allows to reduce their moisture absorption capacity.Aim. Reducing the hygroscopicity of deliquescent substances and obtaining sustained release solid dosage forms by using solid dispersion systems.Materials and methods. Substance: DEAE; excipients: Kollidon® VA 64, Soluplus®, PEG 1500, PEG 6000, PEG 8000, Poloxamer Kolliphor® P 188 and Kolliphor® P 407; reagents: hydrochloric acid, sodium dihydrogen phosphate, potassium hydrogen phosphate. The melt of the components was obtained on a twin-screw laboratory extruder and cast into silicone molds. The resulting solid dosage forms were studied for disintegration in three environments corresponding to the sections of the human gastrointestinal tract.Results and discussion. The active pharmaceutical substance DEAE is characterized as deliquescent substance. The introduction of DEAE into PEG-polymer matrices made it possible to reduce the hygroscopicity of solid dosage forms in the form of bars. The introduction of solubilizers into the melt made it possible to obtain bars with the appropriate organoleptic properties. The release of DEAE from bear- or toroid-shaped bars occurs on average 29–47 % faster than from heart-shaped bars.Conclusion. Compositions based on Soluplus® and Kolliphor® P 407 have proven promising for further development of tiles containing DEAE. In order to create tiles with a slow release, it is recommended to use heart-shaped forms, as they have a smaller surface area.

Various drugs used in oral disintegration tablet formulation

Oral drug administration is more widely accepted because it is used to provide between 50 and 60 percent of medications. The solid dosage forms are commonly utilized since they are simple to administer, precise in their dosage forms, beneficial for self-medication, and preventive of discomfort, and last but not least, the excellent level of patient adherence. The capsules and tablets are the most widely used solid dose form administered orally. Aside from ingesting it does not possess any noteworthy drawbacks. Water plays a crucial function in this swallowing process. Even following this, some people had difficulty swallowing. In order to prevent these issues, mouth dissolving tablets were developed. They have the benefit of not requiring water and don't require swallowing because they dissolve or disintegrate in saliva. In light of the design it began to behave in two ways: first, some tablets disintegrated quickly, taking just a few moments in saliva. Another kind of tablet is known as a "first disintegration tablet" since it contains some substances that slowed down the tablet's rate of breakdown. Review attention was drawn to the concise talk about mouth dissolving tablets and the most recent versions available.

Ultrasound-assisted extraction of itraconazole from pellets: an efficient approach for the recovery of active pharmaceutical compounds from solid dosage forms

IntroductionItraconazole is a widely used broad-spectrum antifungal drug on a global scale. However, its poor water solubility necessitates the development of advanced formulations for its effective use. Currently, itraconazole is available commercially in capsule form, with pellets containing the active drug. The extraction of itraconazole from these granules is often required when developing new formulations. Extracting active pharmaceutical ingredients (APIs) from pellets is crucial in ensuring precise and consistent dosing when producing pharmaceutical dosage forms. Surprisingly, no existing methods for extracting itraconazole from pellets have been reported thus far.ObjectiveTherefore, this study aimed to develop and evaluate an efficient method for extracting this API from pellets.MethodsTwo extraction methods were assessed: conventional Soxhlet extraction and ultrasound-assisted extraction.Results and DiscussionThe results demonstrated that ultrasound-assisted extraction significantly outperformed the conventional method, yielding higher amounts of itraconazole with a high purity level of 96.8%.

Lignin: An Adaptable Biodegradable Polymer Used in Different Formulation Processes.

LIG is a biopolymer found in vascular plant cell walls that is created by networks of hydroxylated and methoxylated phenylpropane that are randomly crosslinked. Plant cell walls contain LIG, a biopolymer with significant potential for usage in modern industrial and pharmaceutical applications. It is a renewable raw resource. The plant is mechanically protected by this substance, which may increase its durability. Because it has antibacterial and antioxidant qualities, LIG also shields plants from biological and chemical challenges from the outside world. Researchers have done a great deal of work to create new materials and substances based on LIG. Numerous applications, including those involving antibacterial agents, antioxidant additives, UV protection agents, hydrogel-forming molecules, nanoparticles, and solid dosage forms, have been made with this biopolymer. For this review, a consistent literature screening using the Pubmed database from 2019-2024 has been performed. The results showed that there is an increase in interest in lignin as an adaptable biomolecule. The most recent studies are focused on the biosynthesis and antimicrobial properties of lignin-derived molecules. Also, the use of lignin in conjunction with nanostructures is actively explored. Overall, lignin is a versatile molecule with multiple uses in industry and medical science.

The Design of Novel 3D-Printed, Moulded, and Oral Viscous Budesonide Formulations for Paediatrics: A Comparative Evaluation of Their Mucoadhesive Properties.

Paediatric eosinophilic oesophagitis (EoE) treatment is challenging due to the limited number of age-appropriate formulations. This study aims to develop and evaluate oral viscous suspensions and solid formulations of budesonide (BUD), focusing on their in vitro mucoadhesive properties, to enhance drug delivery and therapeutic outcomes in paediatric EoE. This study encompasses the development of oral viscous suspensions and orodispersible solid formulations (moulded tablets and 3D-printed dosage forms) containing BUD. The formulations underwent quality control tests as per the European Pharmacopoeia, chemical stability assessments, and an in vitro evaluation of their mucoadhesiveness properties. A validated analytical method enabled accurate BUD quantification and efficient extraction, and all developed formulations demonstrated chemical stability for 30 days, meeting Ph. Eur. quality standards. Three-dimensional printing using SSE successfully produced 1 mg and 0.5 mg BUD printlets, complying with quality tests for conventional tablets. Formulations containing xanthan gum (L2-XG and P1-0.5-XG) exhibited superior mucoadhesive properties. L2-XG showed significantly higher mucoadhesion than L1-MC. Among the solid formulations, P1-0.5-XG demonstrated the highest mucoadhesive properties. This is the first study to develop solid oral dosage forms of BUD at a very low dose, specifically for paediatric use. The results highlight the potential of 3D printing for developing individualised orodispersible BUD formulations with improved bioadhesion for paediatric EoE treatment. The L2-XG formulation and the XG-containing printlets are the most promising formulations in terms of increasing contact time with the oesophageal mucosa, which could translate into improved therapeutic efficacy in this patient population.

Phase-separated polymer blends for controlled drug delivery by tuning morphology

Controlling drug release rate and providing physical and chemical stability to the active pharmaceutical ingredient are key properties of oral solid dosage forms. Here, we demonstrate a formulation strategy using phase-separated polymer blends where the morphology provides a route for tuning the drug release profile. By utilising phase separation of a hydrophobic and a hydrophilic polymer, the hydrophilic component will act as a channelling agent, creating a porous network upon dissolution that will dictate the release characteristics. With ptychographic X-ray tomography and scanning transmission X-ray microscopy we reveal how the morphology depends on both polymer fraction and presence of drug, and how the drug is distributed over the polymer domains. Combining X-ray imaging results with dissolution studies reveal how the morphologies are correlated with the drug release and showcase how tuning the morphology of a polymer matrix in oral formulations can be utilised as a method for controlled drug release.

Therapeutic potential of phytocompounds of Bacopa monnieri (L.) Wettst (literature review)

The aim of the work was to evaluate the pharmacological effects and therapeutic potential of individual compounds and extracts of B. monnieri based on the analysis of data from scientific periodicals regarding chemical composition and biological action. Theoretically significant were the studies of the materials of the scientific-metric database PubMed and Google Scholar over the last five years regarding the chemical composition and biological action of extracts based on B. monnieri and their individual components. The search query was carried out by the Latin name of the plant, with the exception of publications related to botanical research. In separate PubChem searches, names of individual phytocompounds were used to establish structure and distribution in plants. The SuperPred web server was used to predict therapeutic potential. The authors analyzed the chemical composition of the extracts, presented the structural and pharmacological characteristics of bacosides and their aglycones: bacosin and juubogenin, cucurbitacin E, loliolide, betulinic and asiatic acids and the flavonoid oroxindin. The mechanism of action of bacoside on β-amyloid is characterized and illustrated. Using machine learning, the prospects for using the main compounds of bacopa to create drugs were calculated taking into account the ATC classification, their biological effects and alternative plant sources were given. Experimental animal studies of whole aqueous or ethanolic extracts of B. monnieri have been found to support a cognitive enhancement effect. The extract was not toxic to humans. Numerous clinical trials show the effectiveness of the use of extracts in the treatment of anhedonia, depression, Alzheimer's disease, Parkinson's disease, dementia and hyperactivity. An analysis of clinical studies in Ukraine shows that drugs based on B. monnieri can be used in the complex treatment of cognitive impairment associated with dyscirculatory encephalopathy in adults and perinatal CNS damage in children. Considering the amphiphilicity of bacosides and the non-toxicity of extracts, they can be involved in the development of various dosage forms with a wide range of therapeutic applications. Further study of the pharmacological action of B. monnieri and the development of drug technology for solid and liquid dosage forms based on it are promising.

Coating Tablets, Compositions, Recent Advancement and Current Status: A Comprehensive Review

Conventional Tablets are solid oral dosage forms that contain an active pharmaceutical ingredient (API) along with excipients. These tablets are typically prepared through direct compression, wet granulation, or dry granulation. They are designed to disintegrate and release the API in a controlled or immediate manner, depending on the formulation. Tablet coating is a vital process in pharmaceutical technology, designed to improve the therapeutic efficacy, patient compliance, and stability of oral dosage forms. This comprehensive review explores the key aspects of tablet coating, including the types, compositions, and recent advancements. Coating materials such as polymers, plasticizers, and pigments are discussed in detail, along with their roles in controlling drug release, masking taste, and enhancing aesthetic appeal. The recent advancements focus on innovative coating techniques like film coatings, enteric coatings, and the application of nanotechnology to improve precision and functionality. Additionally, the current status of tablet coating is analyzed in terms of regulatory compliance and industry trends. The review highlights the future potential of personalized coatings, smart coatings, and environmentally friendly approaches, showcasing the evolving landscape of tablet coating technologies/pans in modern pharmaceutical manufacturing and development. Keywords: Table coating; dosage form; enteric; coating pans; formulation; advancement; polymers

Esophageal transit of solid oral dosage forms – impact of different surface materials characterized in vitro and in vivo by MRI in healthy volunteers

Acceptable swallowability and complete esophageal transit are decisive for the safe and effective administration of solid oral dosage forms. This applies in particular to the main user group of medicines, older adults, who often suffer from swallowing difficulties. It is well known that surface properties play an important role in this respect. In the past, this has led to the development of numerous coating formulations for tablets with improved swallowability. However, in vitro and especially in vivo data investigating a positive effect of different coating materials is limited. Therefore, we investigated coating materials being based on polyvinyl alcohol, hydroxypropyl methylcellulose, and a copolymer of methacrylate in respect to their influence on swallowability and esophageal transit of a tablet formulation. They were compared to uncoated tablets as well as to hard gelatin capsules. Three in vitro assays suitable for routine use in pharmaceutical development were performed: i.) Wettability test in artificial saliva; ii.) Swelling measurement in artificial saliva; iii.) Measurement of the adhesion between surface materials and a simulated mucosa surface. All three assays resulted in a differentiation of the surface materials. The coated tablets showed favorable behavior compared to uncoated tablets and hard gelatin capsules. To test the effect of the different materials in vivo, an intervention study was conducted. 36 adults were included and the likeliness of prolonged esophageal transit of (un-)coated tablets as well as a hard gelatin capsule of the same weight was objectively evaluated by means of magnetic resonance imaging. While hard gelatin capsules showed highest rates for prolonged esophageal transit, the tendency for adhesion was reduced for uncoated tablets, and least for coated tablets, i.e., prolonged esophageal transit in 22.2 %, 11.1 %, and ≤5.6 % of the cases, respectively. Further differentiation of the coating materials was not possible. Subjective evaluations of each participant with respect to subjective swallowability and esophageal transit did not correlate well with the objective measurements by means of magnetic resonance imaging. The use of coatings in general has a positive influence on esophageal transit. However, the selection of coating type seems to be of greater importance in respect to patients' oral perception of the dosage forms compared to their influence on the probability for prolonged esophageal transit.

Innovative Techniques for Pharmaceutical Waste Management: Enhancing Drug Recovery and Environmental Sustainability

The pharmaceutical sector is a major component of current healthcare, manufacturing and distributing drugs, biological substances, and medical equipment. Despite its advantages, the sector creates enormous waste, including materials for packaging, production by-products, expired or unused drugs, and other residues, creating health and environmental issues. Appropriate pharmaceutical waste handling and medication recovery strategies are vital for limiting these problems. This article aims to investigate and evaluate multiple techniques for recovering pharmaceuticals from pharmaceutical waste, highlighting the significance of sustainable waste management in the pharmaceutical sector. The paper emphasizes the need to use modern methods such as liquid-liquid extraction, membrane crystallization, solid-liquid extraction, and adsorption to recover drugs from pharmaceutical waste. Liquid-liquid extraction exhibits excellent adaptability and efficiency for varied Active Pharmaceutical Ingredients (APIs), whereas membrane crystallization provides low-energy solutions for thermally sensitive compounds. Solid-liquid extraction is useful for recovering APIs from solid dosage forms, while adsorption approaches exploit substances like activated carbon for organic component recovery. Each process has particular benefits and disadvantages, with the selection of methodology based on waste properties and recovery objectives. It emphasizes the promise of these technologies for high extraction yields, purity, and environmental sustainability, supporting effective pharmaceutical waste management procedures. Additionally, difficulties such as cost-effectiveness, scalability, and regulatory compliance are addressed, pointing to opportunities for future research and development to improve the efficacy of drug recovery procedures. In conclusion, using advanced techniques to recover pharmaceuticals from pharmaceutical waste offers a viable way to implement sustainable waste recovery procedures and lessen the pharmaceutical industry's negative environmental effects.

Supramolecular cyclodextrin complexes of biologically active nitrogen heterocycles

The review is devoted to the rapidly developing field of modern supramolecular chemistry - cyclodextrin complexes of biologically active nitrogen heterocycles, such as piperidines, piperazines, morpholines and pyridines. Interest in cyclodextrin complexes is growing due to the search and construction of supramolecular assemblies for targeted drug delivery. The latter is achieved as a result of supramolecular self-assembly, based on the principles of molecular recognition, and is one of the areas of modern chemistry, leading to the creation of new materials with new properties. This review fully demonstrates the ongoing scientific and practical interest in the problem of encapsulation with cyclodextrins, including nanoencapsulation. Encapsulation with cyclodextrins provides a wide range of advantages: obtaining solid dosage forms from liquid ones, stabilizing and protecting active substances from the adverse effects of external factors, increasing solubility, increasing bioavailability, reducing toxicity, prolonging action, etc. The presented review includes recent advances in the field of supramolecular complexes of biologically active nitrogen heterocycles with cyclodextrins and concludes with a discussion and identification of future promising directions for research. The review presents the results of supramolecular self-assembly of biologically active azaheterocycles with cyclodextrins.

Biowaiver monographs for immediate-release solid oral dosage forms: Lemborexant

Lemborexant is a dual orexin receptor antagonist assigned to class II of the Biopharmaceutics Classification System (BCS). Thus, the ICH M9 Guideline excludes immediate-release (IR) solid oral dosage forms containing lemborexant from BCS-based biowaivers, irrespective of their in vitro dissolution behavior. By contrast, classification of lemborexant according to the refined Developability Classification System (rDCS) falls into class I, indicating few biopharmaceutics risks. Customized rDCS investigations identify dissolution as the main risk factor, in line with clinical data in humans which suggest that the absorption of lemborexant is limited neither by solubility nor by permeability. Instead, any risks lie in dissolution. Analysis by the rDCS coupled with biorelevant dissolution testing thus provides a way forward for manufacturers to mitigate the risks associated with changes in formulation or introduction of a generic version prior to running clinical bioequivalence (BE) studies. As a way forward regarding biowaivers for lemborexant and similar cases, where justifying BE based on the current BCS-based approach is not possible, a four-step pathway towards establishing BE virtually could be adopted as follows: (i) rDCS analysis to identify critical bioavailability attributes, (ii) comparative (biorelevant) dissolution testing, (iii) Physiologically Based Biopharmaceutics Modeling (PBBM), and (iv) virtual BE assessment.

Leveraging solid solubility and miscibility of etoricoxib in Soluplus® towards manufacturing of 3D printed etoricoxib tablets by additive manufacturing

This research focuses on exploring the solid solubility and miscibility of Etoricoxib, a poorly water-soluble anti-inflammatory drug, within Soluplus®, a polymer used as a matrix for 3D-printed tablets. By utilizing hot-melt extrusion (HME), the drug was dispersed within Soluplus® to enhance its solubility. The extrudates were then employed in 3D printing to create customized solid oral dosage form. This study’s novelty lies in combining HME and 3D printing, aiming to improve drug incorporation, stability, and effectiveness in the final formulation. Comprehensive characterization techniques, including hot stage microscopy (HSM), scanning electron microscopy (SEM), micro-computed tomography (Micro-CT), florescence microscopy, optical microscopy, X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FT-IR), solubility studies, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and aqueous solubility study were utilized to elucidate the physicochemical properties, thermal stability, and structural integrity for the extruded filaments (the printing ink), and 3D printed tablets made thereof. Furthermore, the in vitro drug release profile of the 3D printed tablet was systematically evaluated, revealing a controlled drug release pattern from the finished dosage form. The systematic investigation reported herein, starting from theoretical miscibility to the printing ink development through HME, detailed characterization of the extruded filaments, and further solid oral formulation development by additive manufacturing can be utilized as a platform technology or a pathway for the development of personalized medicine with drugs having similar physicochemical properties.

Implementing Sediment Delivery Model-Orodispersible Tablet (SeDeM-ODT) Expert System in Cetirizine Dihydrochloride Orally Disintegrating Mini-Tablets (ODMTs) Formulation

In recent years, pediatric medicine has shifted towards solid oral dosage forms, moving away from liquid formulations to create tailored platforms for children. Orally disintegrating mini-tablets (ODMTs), with a diameter below 3 mm, dissolve rapidly in the mouth and represent a promising option. This study aimed to develop ODMTs using various co-process excipients, assessing their suitability with the Sediment Delivery Model-Orally Disintegrating Tablet (SeDeM-ODT) expert system. Favorable Index of Good Compressibility and Bucodispersibility (IGCB) values (> 5) were found for F-MELT® and co-process rice starch (CR), utilizing for ODMT formulation. Cetirizine dihydrochloride (CET) was evaluated for direct compression suitability, revealing flowability deficiencies. Therefore, co-process excipient quantities were adjusted based on flowability compensation. CET-ODMTs containing F-MELT® exhibited higher drug loading capacity than CR (5 and 2.5 mg/table, respectively). Uniformity of mass, content uniformity, and friability met acceptance criteria with no significant differences between formulations. F-MELT®-based CET-ODMTs showed slower wettability due to magnesium stearate lubrication. Ultimately, the SeDeM-ODT expert system facilitated the excipient selection and formulation development, resulting in ODMTs meeting requirements with minimal experimentation.