Taste-masked quinine pamoate tablets for treatment of children with uncomplicated Plasmodium falciparum malaria

Kayitare, Egide; Vervaet, Chris; Mehuys, Els; Kayumba, Pierre Claver; Ntawukulilyayo, Jd; Karema, C; Bortel, Van; Remon, Jean Paul

doi:10.1016/j.ijpharm.2010.03.023

Cited by 7 publications

(8 citation statements)

References 35 publications

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“…Kayitare and colleagues 32 developed a low-dose, taste-masked, fast-dissolving quinine tablet suitable for children with uncomplicated malaria. After bioavailability testing in adult subjects, the taste-masked formulation was evaluated in 56 pediatric patients aged 6 to 59 months with palatability assessed through evaluation of dose administration-related AEs, specifically vomiting, gagging, or other signs of dysphagia, as well as willingness to take the full dose.…”

Section: Assessment Of Palatability In Oral Dosage Form Developmentmentioning

confidence: 99%

A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Squires

Lombardi

Sjostedt³

et al. 2013

Ther Innov Regul Sci

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Various limitations to this systematic review exist, primarily focused on the unavailability of published, early phase development data related to palatability. However, based on results of this review, palatability is often assessed in clinical trials of pediatric dosage forms through the utilization of 2 unvalidated, yet widely accepted, visual scales. There is no standard statistical methodology for analyzing the results of these scales or the cross-comparison of results across studies. Limited evidence regarding a correlation between palatability and treatment adherence in pediatric patients was identified.

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Section: Assessment Of Palatability In Oral Dosage Form Developmentmentioning

confidence: 99%

A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Squires

Lombardi

Sjostedt³

et al. 2013

Ther Innov Regul Sci

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“…The average scores for quality assessment were acceptable. Nineteen, 7, and 2 articles involved studies in children [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26], pregnant women [27][28][29][30][31][32][33], and elderly [34,35], respectively. The studies were conducted during 1982-2013 in 16 countries; 23, 2, and 3 studies in Africa, Asia, and Australia/Oceania, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…The studies were conducted during 1982-2013 in 16 countries; 23, 2, and 3 studies in Africa, Asia, and Australia/Oceania, respectively. Fourteen, 11, and 3 studies involved uncomplicated falciparum malaria [8][9][10][11][12][13][14][15][16][27][28][29][30][31], complicated falciparum malaria [17-25, 32, 33], and non-malaria [9,11,14], respectively.…”

Section: Resultsmentioning

confidence: 99%

“…The clinical efficacy of different dosage regimens and routes of administration in uncomplicated malaria was excellent with a 100% cure rate [8,9,[11][12][13][14][15][16]. It is noted that most articles reported 7-day [8, 9, 11-14] or 14-day [15,16], but not 42-day, cure rates as recommended by the World Health Organization (WHO) for the evaluation of clinical efficacy of drugs for P. falciparum treatment. Three out of the 9 articles reported 100% cure rates in complicated malaria [20,21,23].…”

Section: Therapeutic Relevancementioning

confidence: 99%

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Clinical pharmacokinetics of quinine and its relationship with treatment outcomes in children, pregnant women, and elderly patients, with uncomplicated and complicated malaria: a systematic review

Saeheng

Na‐Bangchang

2022

Malar J

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Background Standard dosage regimens of quinine formulated for adult patients with uncomplicated and complicated malaria have been applied for clinical uses in children, pregnant women, and elderly. Since these populations have anatomical and physiological differences from adults, dosage regimens formulated for adults may not be appropriate. The study aimed to (i) review existing information on the pharmacokinetics of quinine in children, pregnant women, and elderly populations, (ii) identify factors that influence quinine pharmacokinetics, and (iii) analyse the relationship between the pharmacokinetics and treatment outcomes (therapeutic and safety) of various dosage regimens of quinine. Methods Web of Sciences, Cochrane Library, Scopus, and PubMed were the databases applied in this systematic search for relevant research articles published up to October 2020 using the predefined search terms. The retrieved articles were initially screened by titles and abstracts to exclude any irrelevant articles and were further evaluated based on full-texts, applying the predefined eligibility criteria. Excel spreadsheet (Microsoft, WA, USA) was used for data collection and management. Qualitative data are presented as numbers and percentages, and where appropriate, mean + SD or median (range) or range values. Results Twenty-eight articles fulfilled the eligibility criteria, 19 in children, 7 in pregnant women, and 2 in elderly (14 and 7 articles in complicated and uncomplicated malaria, respectively). Severity of infection, routes of administration, and nutritional status were shown to be the key factors impacting quinine pharmacokinetics in these vulnerable groups. Conclusions The recommended dosages for both uncomplicated and complicated malaria are, in general, adequate for elderly and children with uncomplicated malaria. Dose adjustment may be required in pregnant women with both uncomplicated and complicated malaria, and in children with complicated malaria. Pharmacokinetics studies relevant to clinical efficacy in these vulnerable groups of patients with large sample size and reassessment of MIC (minimum inhibitory concentration) should be considered.

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“…However, PTB is a highly soluble drug with a bitter taste, and thus effectively taste masking is critical to patient compliance, and it is also the first and foremost challenging task in the preparation of DPT. 7) In brief, in terms of PTB (a highly soluble drug with an extremely bitter taste), it is a big challenge to develop a tastemasked dispersible tablet (TPDPTs) suitable for industrial production. Here, economic complexation technology combined with direct tablet compression method has been developed to meet the requirements of TPDPTs: (1) TPDPTs should have optimal disintegration and good physical resistance (hardness); (2) low-cost, simple but practical preparation methods are preferred from a cost perspective.…”

mentioning

confidence: 99%

Design and Evaluation of an Economic Taste-Masked Dispersible Tablet of Pyridostigmine Bromide, a Highly Soluble Drug with an Extremely Bitter Taste

Tan

Zhang

et al. 2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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Pyridostigmine bromide (PTB) is a highly soluble and extremely bitter drug. Here, an economic complexation technology combined with direct tablet compression method has been developed to meet the requirements of a patient friendly dosage known as taste-masked dispersible tablets loaded PTB (TPDPTs): (1) TPDPTs should have optimal disintegration and good physical resistance (hardness); (2) a low-cost, simple but practical preparation method suitable for industrial production is preferred from a cost perspective. Physicochemical properties of the inclusion complex of PTB with beta-cyclodextrin were investigated by Fourier transformed infrared spectroscopy, differential scanning calorimetry and UV spectroscopy. An orthogonal design was chosen to properly formulate TPDPTs. All volunteers regarded acceptable bitterness of TPDPTs. The properties including disintegration time, weight variation, friability, hardness, dispersible uniformity and drug content of TPDPTs were evaluated. The dissolution profile of TPDPTs in distilled water exhibited a fast rate. Pharmacokinetic results demonstrated that TPDPTs and the commercial tablets were bioequivalent.Key words pyridostigmine bromide; taste-masked; dispersible tablet; inclusion complex; bioequivalence British Pharmacopoeia defined dispersible tablets (DPTs) as the uncoated tablets or film-coated tablets intended to be dispersed in water before administration giving a homogeneous dispersion. DPTs usually disintegrate within three minutes when put in a small amount (5 to 10 mL) of liquid (clean water or milk). It is easy for caregivers to prepare and easy for sick children to take.1-3) It is well established that DPTs may be a good dosage form of choice for geriatric, pediatric, bedridden, traveler, soldier, nauseous or non-complient patients. DPTs can also give a new lease of life to an existing drug for line extension or/and patenting new dosage form. Up to now, pharmaceutical companies have marketed various types of dispersible dosage forms, such as Afeksin ® by Actavis Ltd., Coartem ® by Novartis and Medicines, 1) Amotaks ® by Polfa Tarchomin SA. 4)Pyridostigmine bromide (PTB; C 9 H 13 BrN 2 O 2 ; molecular weight 261.12; very soluble; c log P −3.1; Fig. 1), also called 3-(dimethylcarbamyloxy)-1-methylpyridinium bromide, functions as a reversible competitive carbamate type of acetylcholinesterase inhibitor. PTB has been used to treat myasthenia gravis for many years.5) The indication for prophylaxis against intoxication with nerve agents (such as sarin and soman) has been recently approved by the U.S. Food and Drug Administration (FDA) and the French Drug Agency.6) So far, the formulations of PTB used clinically are the sugar-coated tablet, sustained release tablet, injection and syrup. DPT may be an appropriate alternative dosage form of PTB. However, PTB is a highly soluble drug with a bitter taste, and thus effectively taste masking is critical to patient compliance, and it is also the first and foremost challenging task in the preparation of DPT. 7) In brief, in ter...

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Taste-masked quinine pamoate tablets for treatment of children with uncomplicated Plasmodium falciparum malaria

Cited by 7 publications

References 35 publications

A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Clinical pharmacokinetics of quinine and its relationship with treatment outcomes in children, pregnant women, and elderly patients, with uncomplicated and complicated malaria: a systematic review

Design and Evaluation of an Economic Taste-Masked Dispersible Tablet of Pyridostigmine Bromide, a Highly Soluble Drug with an Extremely Bitter Taste

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