北京若生智能科技有限公司
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abuse-deterrent extended release tablet technology

✓ Approved

Inspirion Delivery Technologies · 治疗药物

什么是 abuse-deterrent extended release tablet technology？

abuse-deterrent extended release tablet technology 是一种治疗药物，由Inspirion Delivery Technologies研发。该药已获批，用于治疗相关适应症，给药途径：Others。

药物档案

公司Inspirion Delivery Technologies
给药途径Others
状态Approved
来源： ClinicalTrials.gov, Inspirion Delivery Technologies

治疗适应症

abuse-deterrent extended release tablet technology 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Surgical and medical proceduresOral appliance application✓ Approved

相关研究文献

PubMedPharmaceutics2026-10-27

Ethyl Cellulose-Coated Cylindrical Granules for Multi-Unit Sustained-Release Tablets: Trade-Off Between Coating Integrity, Compressibility, Tabletability, and Drug Release.

Li Zhaohua Z, Fan Ying Y, Yang Jingxi J, Zhang Guangshuai G et al.

Background: Cylindrical granules, rather than spherical pellets, are used in certain multi-unit sustained-release tablets (MUSTs), such as mesalazine (MSZ) sustained-release tablets (Pentasa®). Our previous studies established that porosity and aspect ratio govern the tableting behavior of uncoated cylindrical MSZ granules. However, it is unknown how the compressibility, tabletability and release behavior of the coated cylindrical granules will change. Methods: In this study, ethyl cellulose (EC) was used as a model sustained-release coating polymer to systematically investigate the effects of EC coating film on the compressibility, tabletability, and drug-release performance of MSZ cylindrical granules. Results: It was found that increasing EC molecular weight and coating weight gain compromised the compressibility of the coated cylindrical granules, as reflected by increased yield stress values. Structural analysis demonstrated that thicker coatings and higher-molecular-weight EC films were less susceptible to compression-induced damage, preserving coating integrity after tableting. However, this enhanced coating robustness was accompanied by reduced tabletability, as reflected by lower tablet tensile strength at a given compaction pressure. In addition, increasing EC molecular weight and coating weight gain progressively reduced MSZ release from both coated granules and corresponding tablets. Conclusions: These findings demonstrate a trade-off among coating integrity, compressibility, tabletability, and drug-release control in MUST development. The results provide a mechanistic basis and practical guidance for optimizing coated cylindrical granules and balancing coating protection with tablet manufacturability and sustained-release performance.

PMID 42942753
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PubMedPharmaceutics2026-10-27

Impact of Process Parameters on the Quality Attributes of High-Dose Metformin Hydrochloride Film-Coated Tablets.

Duc Nguyen Tan NT, Nguyen Dang-Khoa DK, Liet Huynh Thanh HT, Thiet Nguyen Huynh NH et al.

Background/Objectives: Formulating high-dose metformin hydrochloride film-coated tablets is challenging due to the poor flowability and compressibility inherent to high drug loading. To ensure process robustness and consistent product quality, understanding the impact of manufacturing variables is crucial. This study evaluated the effects of key process parameters on the quality attributes of 1000 mg metformin hydrochloride tablets to establish optimal processing conditions for reliable production. Methods: The manufacturing process, comprising wet granulation, compression, and film coating, was investigated to evaluate the influence of key process parameters on tablet quality attributes. Granules were characterized for bulk density, tapped density, and compressibility index. Core tablets were evaluated for physical appearance, weight variation, hardness, and dissolution at a 45 min sampling point across various compression forces and tableting speeds. Film-coating efficiency was assessed based on coating quality, dissolution behavior, and stability. Favorable manufacturing conditions were empirically identified through single-variable optimization and statistical analysis. Results: Wet granulation conducted at a chopper speed of 1400 rpm for 7 min yielded granules with the lowest compressibility index (11.88%), demonstrating significantly improved flowability. Compression at a force of 10 kN and a speed of 40 rpm produced core tablets with acceptable appearance, robust hardness (7.06-7.37 kP), and complete drug release (100%). Tablet hardness was governed by a strong interaction between compression force and tableting speed (partial η2 = 0.929, p < 0.001) rather than by either factor alone: at 20 kN, hardness collapsed sharply once tableting speed reached 30 rpm, coincident with mild capping, identifying this force-speed combination as a process-failure condition. For the coating process, maintaining a tablet bed surface temperature of 40 °C ensured optimal coating uniformity without compromising product quality. Dissolution profile comparison against a coated reference product in the primary dissolution medium (pH 6.8) yielded f2 similarity values above 50 for all eight core tablet conditions, and stability testing under accelerated/thermal-stress conditions (up to 65 °C) confirmed maintained dissolution, assay, and related-substance (1-cyanoguanidine) compliance for both the test and reference products. The optimized manufacturing conditions successfully produced film-coated tablets that conformed to all predetermined quality specifications. Conclusions: Manufacturing process parameters significantly influenced the quality attributes of high-dose metformin hydrochloride film-coated tablets. Proper selection and control of these processing conditions ensured consistent granule properties, optimal tablet quality, and enhanced manufacturing robustness.

PMID 42942796
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PubMedPharmaceutics2026-10-27

In Vitro Comparison of Microenvironmental pH Modulation Approaches for Minzasolmin.

Stauffer Fanny F, Bouquelle Anne A, Le Meur Sarah S, Segregur Domagoj D et al.

Background/Objectives: Minzasolmin is a weakly basic drug developed as a potential therapy in Parkinson's. Amongst the strategies that have been developed to enhance API solubility, pH modification is an effective and patient-centric approach that improves solubility by creating a microenvironmental pH around the drug. The objective of this study was to evaluate different formulation approaches to develop an immediate-release tablet or capsule containing fumaric acid as a pH modifier. Methods: Ten formulations were developed, varying the degree of contact between the API and pH modifier. These formulations were then assessed in three biorelevant dissolution conditions to estimate their robustness towards variations in gastric pH. Results: In highly buffered conditions, only the over-encapsulated tablet showed a clear improvement in the dissolution profile, with up to 5.1 times the percentage dissolved compared to the capsule without acid and up to 1.4 times compared to the target granule-in-capsule with acid. In low-buffered conditions, though, all prototypes with acid showed an improvement in the percentage dissolved, between 54 and 79 times compared to that of the capsule without acid, regardless of the degree of contact between the organic acid and the API. This was associated with a decrease in pH to 5 in the gastric compartment. Conclusions: These results suggested that the acidic microenvironment, estimated via the bulk pH, and hence the dissolution rate may not require such a high degree of contact between the API and the pH modifier. Based on in vitro results, the over-encapsulated tablet as well as prototypes with a lower degree of contact between the acid and PI will be evaluated in vivo in a future study to evaluate the bio-relevance of the approach.

PMID 42942775
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PubMedDrug delivery2026-10-27

Linking formulation composition to pharmacokinetic and pharmacodynamic responses: a predictive framework for sustained-release tablets.

Song Sungmin S, Park Meoung Jun MJ, Pyo Jun Hyung JH, Kim Tae Hwan TH et al.

The development of sustained-release formulations remains largely empirical and often requires iterative in vitro and in vivo studies to achieve desired pharmacokinetic profiles and therapeutic outcomes. In this study, we developed a formulation-driven predictive framework that links formulation composition to pharmacokinetic and pharmacodynamic responses by integrating design of experiments (DoE), in vitro-in vivo correlation (IVIVC), and population pharmacokinetic/pharmacodynamic (PK/PD) modeling. This approach enables the prediction of both plasma concentration-time and pharmacodynamic response-time profiles directly from formulation composition. Using ticagrelor as a model drug, nineteen sustained-release formulations were prepared and characterized in vitro based on a mixture design with three formulation variables. Three formulations spanning fast, medium, and slow dissolution rates were selected for in vivo pharmacokinetic and pharmacodynamic evaluation in beagle dogs. In vitro dissolution kinetics were described using a Michaelis-Menten model, and the maximum dissolution rate (Vmax) was used as a common linking parameter across the DoE, IVIVC, and PK/PD components. A population PK/PD model incorporating time-dependent dissolution and site-dependent absorption processes was established, and a Level A IVIVC was developed by correlating in vitro and in vivo Vmax values. The framework was validated using both internal and external formulations and successfully predicted pharmacokinetic and pharmacodynamic profiles from formulation composition alone. Prediction errors were within 12.70% for internal validation formulations and within 9.67% for an additionally prepared external validation formulation, meeting FDA criteria for IVIVC predictability. This framework provides a mechanistically grounded strategy for model-informed optimization of sustained-release tablet delivery systems.

PMID 42937083
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PubMedAAPS PharmSciTech2026-10-27

Factors Influencing Powder Compressibility: Mechanistic Insights for Robust Pharmaceutical Tablet Manufacturing.

Mahurkar Hrushab Rajabhau HR, Bhimrao Londhe Sachin LS, Kumar Suraj S, Agrawal Ashish K AK et al.

Compressibility is a critical material attribute in tablet manufacturing, as it governs powder densification, inter-particulate bonding, and the mechanical integrity of solid oral dosage forms. Intrinsic solid-state properties such as polymorphism, crystal structure, molecular packing, slip planes, and hardness influence the primary mechanism for deformation and ultimately determine whether materials undergo plastic deformation, elastic deformation, or brittle fracture during compaction. These effects are controlled by the properties of the particles and surface properties. Factors such as particle size and shape, surface free energy, particle aggregation, density, and flow affect the development of the contact area and the transmission of stress within the tablet. Environmental conditions and processing parameters also alter these fundamental responses, thereby affecting densification efficiency, tensile strength, and defect formation. Compressibility, compactibility, and tabletability are determined by these interrelated factors, which ultimately influence manufacturability and product robustness. This review emphasizes the importance of a holistic understanding of the mechanisms governing API compressibility by integrating solid-state properties, compaction behavior, and empirical modeling techniques. It highlights how these interconnected factors influence powder desnsification, mechanical strength, and tablet performance, providing a scientific framework for the rational design and optimization of pharmaceutical formulations. Furthermore, the concept discussed in this review may facilitate the application of Quality by Design(QbD) principles and support the development of robust manufacturing strategies for solid oral dosage forms.

PMID 42934395
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PubMedFoods (Basel, Switzerland)2026-10-27

Controlling Microbial Spoilage of Aquatic Products with Hurdle Technology: A Review.

Liu Meng M, Gao Shuai S, Tao Xinran X, Liu Bingshuang B et al.

Spoilage due to microbial proliferation is the primary cause of the decline in the quality and nutritional value of aquatic products. Current research largely focuses on various antimicrobial methods, yet each antibacterial preservation technology has certain limitations in maintaining storage quality and prolonging the shelf life of aquatic products. This paper categorizes the spoilage microorganisms of aquatic products and highlights that Shewanella spp. and Pseudomonas spp. are common spoilage organisms. The multiple antimicrobial mechanisms of hurdle technology are examined: combined hurdles are classified into five patterns (physical-physical, physical-chemical, physical-biological, biological-chemical, and biological-biological), and their aquatic applications are reviewed together with emerging intelligent controlled-release antibacterial packaging. Aims to provide theoretical references for the iterative optimization of aquatic product preservation technologies.

PMID 42940258
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