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Data evaluating triamcinolone acetonide and triamcinolone hexacetonide loaded poly(δ-valerolactone-co-allyl-δ-valerolactone) microparticles.

ABSTRACT: Advanced drug delivery strategies can be used to enhance the therapeutic effectiveness of locally delivered corticosteroids. Poly(δ-valerolactone-co-allyl-δ-valerolactone) microparticles (PVL-co-PAVL MPs) were evaluated for delivery of two corticosteroids, triamcinolone acetonide and triamcinolone hexacetonide. PVL-co-PAVL MPs were prepared using a modified oil-in-water emulsification method, followed by a UV-initiated cross-linking process. The resulting PVL-co-PAVL MPs were purified with an excess amount of water and then acetone to remove residual surfactant, cross-linker, and catalyst before lyophilization. Triamcinolone acetonide and triamcinolone hexacetonide were independently loaded into the resulting PVL-co-PAVL MPs via a post-loading swelling-equilibrium method. The drug-loaded MPs were characterized in terms of drug loading (determined by high-performance liquid chromatography, HPLC), thermal properties (determined by differential scanning calorimetry, DSC), and in vitro drug release kinetics (with quantification of drug using HPLC) to better understand the suitability of PVL-co-PAVL MPs for delivery of corticosteroids. These data demonstrate the potential of PVL-co-PAVL MPs as a promising drug delivery platform for the sustained release of corticosteroids. Raw data have been made available on Mendeley Data. Additional details on PVL-co-PAVL MPs were previously reported [1].

SUBMITTER: Bao Z

PROVIDER: S-EPMC10025086 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Data evaluating triamcinolone acetonide and triamcinolone hexacetonide loaded poly(δ-valerolactone-co-allyl-δ-valerolactone) microparticles.

Bao Zeqing Z Jung Sungmin S Bufton Jack J Bannigan Pauric P Aguiar Dean J DJ Allen Christine C

Data in brief 20230301

Advanced drug delivery strategies can be used to enhance the therapeutic effectiveness of locally delivered corticosteroids. Poly(δ-valerolactone-co-allyl-δ-valerolactone) microparticles (PVL-co-PAVL MPs) were evaluated for delivery of two corticosteroids, triamcinolone acetonide and triamcinolone hexacetonide. PVL-co-PAVL MPs were prepared using a modified oil-in-water emulsification method, followed by a UV-initiated cross-linking process. The resulting PVL-co-PAVL ...[more]

PMID: 36950558

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Project description:BackgroundIntra-articular corticosteroids are commonly used for pain relief in patients with knee osteoarthritis. Simultaneous intra-articular corticosteroid (CS) knee injections may be beneficial for the ~80-90% of patients who present with, or develop, bilateral knee osteoarthritis, but concurrent injections may increase systemic CS exposure and data on safety/tolerability are lacking. Triamcinolone acetonide extended release (TA-ER) has shown decreased systemic triamcinolone acetonide exposure compared with traditional triamcinolone acetonide crystalline suspension (TAcs) after a single knee injection in patients with knee osteoarthritis. This phase IIa study was designed to assess the safety and systemic triamcinolone acetonide exposure following injections of TA-ER or TAcs into each knee of patients with bilateral knee osteoarthritis.MethodsPatients (⩾40 years) meeting American College of Rheumatology criteria for knee osteoarthritis in both knees received concurrent single intra-articular injections of TA-ER 32 mg or TAcs 40 mg into each knee (total: 64 mg and 80 mg, respectively) and were followed for 6 weeks. Safety was evaluated based on treatment-emergent adverse events (TEAEs). Blood samples for pharmacokinetic analysis were collected pre-injection, and at the following postinjection time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 h, and days 8, 15, 29, and 43.ResultsBaseline characteristics were balanced between patients randomly assigned to TA-ER (n = 12) or TAcs (n = 12). Both treatments were well tolerated with comparable TEAE profiles. Peak plasma triamcinolone acetonide concentrations (Cmax) were lower following bilateral TA-ER injections [geometric mean, 2277.7 pg/ml (95% CI, 1602.13-3238.04)] compared with bilateral TAcs injections [7394.7 pg/ml (2201.06-24,843.43)], with median times to Cmax (Tmax) of 4.5 and 6.5 h, respectively.ConclusionsIn patients with bilateral knee osteoarthritis, intra-articular injection of TA-ER into both knees was well tolerated. Consistent with pharmacokinetic profiles observed after a single knee injection, plasma triamcinolone acetonide concentrations were lower after bilateral TA-ER injections compared with the higher and more variable concentrations observed after bilateral TAcs injections.Clinicaltrialsgov identifierNCT03378076.

Dataset Information

Data evaluating triamcinolone acetonide and triamcinolone hexacetonide loaded poly(δ-valerolactone-co-allyl-δ-valerolactone) microparticles.

Publications

Data evaluating triamcinolone acetonide and triamcinolone hexacetonide loaded poly(δ-valerolactone-<i>co</i>-allyl-δ-valerolactone) microparticles.

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