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abuse-deterrent extended release tablet technology

✓ Approved

Inspirion Delivery Technologies · therapeutic agent

What is abuse-deterrent extended release tablet technology?

abuse-deterrent extended release tablet technology is a therapeutic agent developed by Inspirion Delivery Technologies. It is approved for therapeutic indications via others.

Drug Profile

CompanyInspirion Delivery Technologies
RouteOthers
StatusApproved
Sources: ClinicalTrials.gov, Inspirion Delivery Technologies

Therapeutic Indications

abuse-deterrent extended release tablet technology is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresOral appliance application✓ Approved

Related Research Articles

PubMedDrugs in R&D2026-06-09

Development and Optimization of a Biphasic-Release Acetazolamide Tablet-in-Tablet Formulation.

Wang Si-Kai SK, Li Wei W, Guo Miao-Miao MM, Han Man M et al.

High-altitude illness (HAI) poses health risks to individuals at high altitudes, and acetazolamide (ACZ) is the only Food and Drug Administration (FDA)-approved prophylactic drug. Conventional immediate-release (IR) tablets and extended-release (ER) capsules do not simultaneously provide early drug availability and prolonged coverage. This study aimed to develop a biphasic-release ACZ tablet-in-tablet (ACZ-TIT) formulation as a proof-of-concept oral dosage form integrating IR and ER. ACZ-excipient compatibility was assessed using Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and powder X-ray diffraction (PXRD), and solubility was evaluated in physiologically relevant media. Formulation optimization was performed via single-factor studies and response surface methodology (RSM). Quality control included weight, hardness, friability, content, and related substances. In vitro dissolution studies were conducted, and drug release kinetics were analyzed using multiple models. No new incompatibility signals were observed between ACZ and the selected excipients, and only small solubility differences were found across the tested media. ACZ-TIT showed a biphasic-release profile, with 25.3% drug release at 0.5 h and 86.5% at 10 h. Physical properties were within pharmacopeial limits (weight variation ≤ 2.65%, hardness 112.0 ± 21.2 N, friability 0.18%, and assay relative standard deviation < 1.2%), and the related substances were found to be within the specified limits. Release kinetics were best described by the Ritger-Peppas model (R2 = 0.993), supporting diffusion-dominated ER. ACZ-TIT may provide rapid initial release followed by sustained exposure, which could help address limitations of currently available ACZ dosage forms. In vivo pharmacokinetic and clinical studies are still required to establish clinical applicability.

PMID 42262722
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PubMedThe AAPS journal2026-06-09

Guiding the Molnupiravir Tablet Formulation Using Physiologically Based Biopharmaceutics Modeling and Successfully Establishing Dissolution Safe Space.

Morrow Thomas T, Jarvi Nicole N, Halota Madeline M, Sun Cheng C et al.

Physiologically Based Biopharmaceutics Models (PBBMs) are evolving tools which can be used to aid in drug product quality specifications. PBBMs have gained increased regulatory interest and acceptance over the past 5 years. For molnupiravir, PBBM has been used for: a) calculation of a bioequivalence safe space for capsule formulation and tablets, b) informing of the definitive bioequivalence study (P011) with a target tablet formulation selection designed to be bioequivalent to the capsule formulation, c) selection of a deliberately slower release tablet formulation (beyond f2 similarity criteria) designed to widen the dissolution knowledge space, d) help select the clinically relevant specification and the dissolution bioequivalence safe space. PBBM data inputs, model development, validation, and application using data from several independent clinical studies are described. Predictive errors for Cmax and AUC were < 25%. The z-factor for dissolution data modeling is described for QC (Quality Control) method(s). The molnupiravir bioequivalence safe space or knowledge space widening is described. The value of the wider dissolution space includes increased potential flexibility with scale-up and post approval changes (SUPAC), including adding or changing a site for a high-volume drug product such as molnupiravir. PBBM is not only important in the development of drug products aiding formulation selection, but can also be a key component toward regulatory flexibility and approval of clinically relevant specifications, such as when the clinical knowledge space has been widened through inclusion of a slow-release variant, as was done for the relative bioavailability study for molnupiravir.

PMID 42260257
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PubMedInternational journal of biological macromolecules2026-06-09

Double encapsulation with porous starch and cellulose: A strategy for enhanced probiotic protection in microcapsules and tablets.

Na Guoqi G, Zou Minxin M, Kong Lu L, Hu Xiufa X et al.

Maintaining probiotic viability during tablet manufacturing and storage remains a critical challenge in functional food development. In this study, a double-layer microencapsulation system was developed using porous starch (PS) as the core carrier and cellulose derivatives (microcrystalline cellulose, MCC; hydroxypropyl cellulose, HPC; and hydroxypropyl methylcellulose, HPMC) as coating materials to enhance probiotic protection and tableting performance. Among the formulations, PS-HPMC presented the highest encapsulation efficiency, which was ascribed to the formation of a compact coating structure. The double-layer microcapsules significantly improved the stress resistance of Lactobacillus plantarum. In particular, the PS-HPMC system showed viability losses of 0.07 log CFU/g under acidic conditions and 1.97 log CFU/g under bile salt treatment, and it retained a survival rate of 44.09% after tablet compression. In vitro gastrointestinal digestion revealed a controlled release profile of probiotics, which followed the Korsmeyer-Peppas model. A viable count of 6.67 log CFU/g was maintained after digestion, demonstrating effective protection of probiotics during gastrointestinal transit. In addition, PS-HPMC tablets preserved 10.80 ± 0.02 log CFU/g after 30 days of storage at 4 °C, and the predicted shelf life based on the first-order kinetic model reached 202.6 days, indicating the double-layer structure enhanced storage stability and prolonged shelf life. The prepared tablets also exhibited satisfactory mechanical strength and disintegration properties. Overall, the cellulose-coated porous starch system effectively enhanced the viability and stability of probiotics in solid dosage forms, providing a promising strategy for the development of functional foods.

PMID 42259418
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PubMedPakistan journal of pharmaceutical sciences2026-06-09

Formulation and in-vitro characterization of okra mucilage-based controlled release hydrogels.

Khaliq Mriba M, Irfan Siddique Muhammad M, Soomro Samreen S, Tariq Mamoona M et al.

Certain drugs at therapeutic doses can cause gastrointestinal toxicity, which controlled-release formulations help to address. Natural polymers are widely used in drug delivery due to their non-toxic, biodegradable, and biocompatible properties. Okra mucilage powder (OMP) is especially promising because of its strong gelling ability and pH-sensitive behavior. This study aimed to develop OMP-based hydrogels for the controlled release of methotrexate (MTX) over extended periods via free-radical polymerization. Acrylic acid (AA) was used as the monomer with OMP and gelatin as polymers, N, N-methylene bis-acrylamide (MBA) as the crosslinker, and ammonium persulfate (APS) as the initiator. SEM analysis revealed a porous, rough structure that facilitates MTX loading. Thermal stability and chemical compatibility were confirmed by TGA and FTIR analyses. The hydrogels exhibited pH-dependent swelling, with the highest at pH 7.4 and the lowest at pH 1.2. Formulation OG3 with increased gelatin (1.6%) and MBA (0.6%) showed the best stability and controlled release (r²=0.996). Drug release followed the Korsmeyer-Peppas model (r²≥0.996), demonstrating successful development of stable, pH-responsive hydrogels for MTX delivery.

PMID 42262204
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PubMedScientific reports2026-06-09

Explaining reported generative AI engagement in higher education: an extended TAM with ethical compatibility and reliance-based trust.

Liu Zhenyu Z, Fu Jing J, Cao Yanan Y, Khayatnezhad Sahar S

The rapid integration of generative artificial intelligence (AI) tools into higher education has intensified conversations regarding usefulness, ethical alignment, and responsible engagement. Unlike traditional technology acceptance studies that focus on initial use, this study examines AI use intensity among active university users. Building on an extended Technology Acceptance Model (TAM), the model incorporates AI-Alignment Construct, reliance-based trust in AI outputs, and normative alignment within academic contexts. Data were collected from 637 university students and analyzed using variance-based structural equation modeling. The results indicate that perceived usefulness remains the strongest predictor of AI use. Furthermore, reliance-based trust and AI-Alignment Construct demonstrate statistically significant correlations with engagement, whereas moderation hypotheses were not supported. These findings suggest that ethical and trust-related mechanisms operate primarily at the attitudinal alignment level rather than as boundary conditions within this cross-sectional framework. Moreover, the study contributes by repositioning TAM within a post-adoption engagement context and clarifying the bounded conceptualization of ethics and trust in AI-mediated learning environments. Practical implications emphasize calibrated AI integration, transparent governance, and assessment design aligned with academic integrity. Finally, the findings are associative in nature and should be interpreted within the methodological constraints of self-reported, cross-sectional data.

PMID 42259935
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PubMedCurrent neuropharmacology2026-06-09

A Preclinical Review on Novel μ Opioid Receptor Modulators as Potential Candidates for Opioid Use Disorder Treatment.

Jali Abdulmajeed M AM

OUD is a major worldwide health concern, with high rates of relapse and poor outcomes from existing treatments, including methadone, buprenorphine, and naltrexone. Recent preclinical research has revealed innovative immunotherapeutic and pharmacological approaches aimed at in-creasing safety and efficacy while reducing dependency and respiratory depression. The production of antibodies, anti-opioid immunotherapies, such as hapten-carrier-adjuvant conjugate vaccines block the penetration of opioids into the central nervous system and lessen their reinforcing effects without causing receptor-mediated toxicity. The Structure-based design and receptor modeling have developed remodeling of immunotherapy in the creation of novel μ-Opioid Receptor (MOR) modulators, including partial agonists and Positive Allosteric Modulators (PAMs). Novel modulators with varying efficacies at the MOR have shown promising therapeutic effects in several preclinical models (in vitro and in vivo) that are used to investigate abuse-related features. These novel modulators offer the benefits of MOR agonists, with fewer downsides than MOR agonists, partial agonists, and antagonists. G-protein biased signalling shows promise for separating analgesia from adverse effects like tolerance and dependence. Moreover, the Extended-release formulations and computational approaches have expedited the discovery of compounds with enhanced pharmacokinetic properties. This review shows how preclinical research on MOR modulators, particularly those with tunable intrinsic efficacy, may result in safer and more precisely focused treatments for opioid dependency while summarizing the available pharmacological choices for OUD. In order to better align experimental advancements with patient-centered therapeutic outcomes, future research should incorporate behavioral, molecular, and immunopharmacological approaches in addition to focusing on translational biomarkers, long-term safety profiling, sex-specific responses, and real-world effectiveness studies.

PMID 42261161
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