A Novel Paracetamol 1,000 mg Sustained Release Formulation vs Conventional Paracetamol 500 mg Formulation in Patients with Fever and Pain: A Randomized Noninferiority Trial

Ghosh, Santanu; Patel, Jigar; Patel, Hiren; Pandya, Nilay U.; Naik, S. Vinod; Patel, Hetal

doi:10.1111/pme.12047

Cited by 3 publications

(1 citation statement)

References 8 publications

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“…Besides immediate release (IR) formulations for oral use, such as tablets, oral suspensions and effervescent tablets, there are modified-release (MR) formulations of paracetamol available as well. In the literature, depending on the authors, MR formulations are sometimes also referred to as prolonged-release (PR), slow-release/sustained-release, controlled-release, delayed or extended-release (ER) formulations, and they were developed to ensure longer duration of action and pain relief 2–4…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of modified-release paracetamol for acute and chronic pain: a systematic review protocol

2019

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IntroductionParacetamol (acetaminophen) is widely used for management of mild-to-moderate pain and reduction of fever. It is available as immediate release (IR) and modified-release (MR) formulation. In 2017, European Medicines Agency recommended a suspension of marketing of MR paracetamol in the European Union. Benefit-risk balance of these products has been assessed as negative as data showed that existing procedures for overdose management may not be efficient. Since MR paracetamol is still available in other countries (Australia and USA) and there is no available systematic review (SR) of efficacy and safety of MR paracetamol in the literature, we have decided to perform one to evaluate available data from randomised clinical trials (RCTs).Methods and analysisUsing predefined search criteria, we will search EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform to identify RCTs evaluating efficacy and safety of MR paracetamol alone in any dose or duration for any pain. Participants are defined as adults and adolescents (over 12 years). Primary efficacy outcomes will be pain intensity, pain relief and sleep. Primary safety outcomes will be the number of patients experiencing any (serious) adverse event, the number of patients withdrawn due to adverse events and the number of patients with gastrointestinal and hepatic adverse events. Data analysis will be subdivided based on different clinical syndromes. Meta-analysis will be conducted if possible. Cochrane risk of bias (RoB) tool with seven dimensions will be used to assess RoB of individual studies.Ethics and disseminationThis SR will include only data collected from trial reports; therefore, an ethical approval will not be sought. We will publish the protocol and our findings in peer-reviewed journals.PROSPERO registration numberNCT42018115769.

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Section: Introductionmentioning

confidence: 99%

Efficacy and safety of modified-release paracetamol for acute and chronic pain: a systematic review protocol

2019

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Deriving harmonised permitted daily exposures (PDEs) for paracetamol (acetaminophen) CAS #: 103-90-2

Gromek

Hawkins

Bernier

et al. 2020

Regulatory Toxicology and Pharmacology

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Modified Release of Acetaminophen from Matrix Tablet Formulations: Influence of Tablet Geometry

Vlachou

Siamidi

Konstantinou

et al. 2024

LDDD

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Background: Acetaminophen (APAP) or otherwise called paracetamol is a widely used over-the-counter, analgesic (common conditions treated include headaches, backache, toothache, muscle aches, arthritis, sore throat etc.) and antipyretic drug. It can be administered orally, in the form of a tablet (plain, effervescent, orodispersable, etc.) or liquid, rectally in the form of suppository or by injection (intravenously or intramuscularly). It is well absorbed orally with a plasma elimination half-life ranging from 1 to 4 h. The modified release oral formulation can prolong its therapeutic effects by maintaining APAP average plasma concentrations. Objective: In the context of this work, two APAP formulation tablets with different geometries were produced from standard pharmaceutical excipients, to investigate the role of altered tablet geometry in modified oral drug delivery. Methods: APAP tablets were prepared by direct compression, using hydroxypropyl methylcellulose (HPMC K15M), polyvinylpyrrolidone (PVP, MW: 55,000) and magnesium stearate, as ingredients. The release profiles were probed in aqueous dissolution media (pH 1.2 and 6.8), to simulate the conditions in the gastrointestinal tract, in a United States Pharmacopeia (USP) dissolution paddle apparatus II and analyzed using a ultraviolet (UV) spectrophotometer (λmax = 244 nm). Results: The results indicated that the tablets were within the acceptable range of all evaluation parameters (tablet dimensions, drug content, weight variation, and breaking force) as defined by the international standards stated in the US Pharmacopoeia. The dissolution results showed that the APAP’s release profile was controlled by the tablets’ different geometries and specifically the surface area (SA) and the surface area/volume (SA/V) ratio of the different tablets. The tablets with smaller SA/V ratios and SA showed slower drug release, indicative of a modified release motif. Conclusion: Altered tablet geometry plays an important role in APAP modified oral drug delivery.

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A Novel Paracetamol 1,000 mg Sustained Release Formulation vs Conventional Paracetamol 500 mg Formulation in Patients with Fever and Pain: A Randomized Noninferiority Trial

Abstract: Both the formulations of paracetamol were clinically and statically equivalent. Paracetamol 1,000 mg SR formulation is noninferior to conventional paracetamol 500 mg tablets.

Cited by 3 publications

References 8 publications

Efficacy and safety of modified-release paracetamol for acute and chronic pain: a systematic review protocol

Efficacy and safety of modified-release paracetamol for acute and chronic pain: a systematic review protocol

Deriving harmonised permitted daily exposures (PDEs) for paracetamol (acetaminophen) CAS #: 103-90-2

Modified Release of Acetaminophen from Matrix Tablet Formulations: Influence of Tablet Geometry

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