Ghost-Pill-Buster: A Case Study of Intact Levetiracetam Extended-Release Tablets after Dissolution Testing

Sun, Dajun; Wen, Hu; Externbrink, Anna; Gao, Ziwen; Keire, David A.; Krauss, Gregory L.; Jiang, Wenlei

doi:10.1007/s40263-016-0332-9

Cited by 4 publications

(2 citation statements)

References 15 publications

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“…While there are once daily options, including extended‐release levetiracetam and zonisamide (Hasegawa et al, 2008; Heller et al, 2018), the large pill size of extended‐release levetiracetam and the capsule formulation of zonisamide may make administration difficult for cats that do not tolerate oral medications. Furthermore, unlike Qudexy®XR, the large extended‐release levetiracetam tablets must be swallowed whole in order to avoid compromising the extended release properties (Sun et al, 2016). Administration challenges may lead to fluctuations in plasma drug concentration and/or discontinuation of treatment.…”

Section: Introductionmentioning

confidence: 99%

The pharmacokinetics of single oral dose extended‐release topiramate and adverse effects after multi‐dose administration in healthy cats

Graham

Foss

Reinhart

et al. 2023

Vet Pharm & Therapeutics

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Topiramate is a broad-spectrum, second-generation antiseizure medication that has been available for the treatment of partial onset and generalized tonic-clonic seizures in the United States since 1996 (Chung, 2015;Wang et al., 2017) and has also been implicated as a first-line option for the treatment of migraine headaches (Silberstein, 2017;Silberstein et al., 2012). Topiramate's primary antiseizure mechanisms of action include blocking voltage-gated sodium channels and enhancing gamma-aminobutyric acid activity and may also include negatively modulating L-type calcium channels (Chung, 2015;Wang et al., 2017;Zhang et al., 2000). Aside from its antiseizure properties, topiramate's other mechanisms of action include antagonizing A-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)/kainite receptors and weakly inhibiting carbonic anhydrase II and IV isoenzymes (Wang et al., 2017). In addition to an immediate release formulation, there are two extended-release (XR) formulations, Trokendi XR® (TXR; Supernus Pharmaceuticals, Inc.)and Qudexy® XR (QXR; Upsher-Smith Laboratories, LLC), approved for human use. Qudexy® XR is manufactured in capsules that contain coated beads, which allow for slow-release of the medication over a 24-hour period. These capsules can be opened and sprinkled

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Section: Introductionmentioning

confidence: 99%

The pharmacokinetics of single oral dose extended‐release topiramate and adverse effects after multi‐dose administration in healthy cats

Graham

Foss

Reinhart

et al. 2023

Vet Pharm & Therapeutics

View full text Add to dashboard Cite

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“…[ 2 ] Sometimes the shell encasing this sustained release tablet fails to disintegrate leading to the passage of ‘Ghost pills,’ a term coined for such tablets appearing unchanged in faeces. [ 3 , 4 ] This may lead to severe anxiety and a sense of inadequate pain relief for the patient.…”

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confidence: 99%

Morphine Sustained Release Tablets Becoming Ghost Pill: A Palliative Conundrum

Garg

Gautam

Dhiraaj

2022

IJPC

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The Single‐Dose Pharmacokinetics of a Compounded Levetiracetam Formulation and Bioequivalence to a Commercial Formulation in Healthy Dogs

Paushter,

Foss,

Reinhart

et al. 2024

Vet Pharm & Therapeutics

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Levetiracetam (LEV) is an anti‐epileptic drug used extra‐label in dogs. Commercially available extended‐release formulations (LEV‐ER), administered twice daily, cannot be crushed or split, limiting their use in small dogs. A compounded LEV‐ER formulation (PO‐COMP) can purportedly be partitioned without loss of extended‐release properties. The aims of this study were to establish the pharmacokinetic parameters of PO‐COMP, divided at the tablet score, and determine the bioequivalence of partitioned PO‐COMP to an intact commercially available Food and Drug Administration‐approved human oral generic formulation of LEV‐ER (PO‐COMM). In a randomized crossover design, 12 healthy dogs received a single IV dose (30 mg/kg) of IV‐COMM, a single oral dose (500 mg) of intact PO‐COMM, or a single oral dose (500 mg) of partitioned PO‐COMP and underwent serial measurement of plasma LEV concentrations over 24 h. PO‐COMP was bioequivalent to PO‐COMM using the 90% confidence interval method for maximum concentration (−3.2% difference [CI −7.4% to −1.1%]) and area under the curve (−14.4% difference [CI −17.8% to 10.8%]). PO‐COMP may improve medication adherence and seizure control relative to immediate‐release LEV, which requires three times daily dosing. Efficacy studies of PO‐COMP are warranted.

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Ghost-Pill-Buster: A Case Study of Intact Levetiracetam Extended-Release Tablets after Dissolution Testing

Cited by 4 publications

References 15 publications

The pharmacokinetics of single oral dose extended‐release topiramate and adverse effects after multi‐dose administration in healthy cats

The pharmacokinetics of single oral dose extended‐release topiramate and adverse effects after multi‐dose administration in healthy cats

Morphine Sustained Release Tablets Becoming Ghost Pill: A Palliative Conundrum

The Single‐Dose Pharmacokinetics of a Compounded Levetiracetam Formulation and Bioequivalence to a Commercial Formulation in Healthy Dogs

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