Challenge of paediatric compounding to solid dosage forms sachets and hard capsules – Finnish perspective

Sivén, Mia; Kovanen, Satu; Siirola, Outi; Hepojoki, Tuomas; Isokirmo, Sari; Laihanen, N.; Eränen, Tiina; Pellinen, Jukka; Juppo, Anne

doi:10.1111/jphp.12648

Cited by 8 publications

(14 citation statements)

References 19 publications

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“…The typical methods for manipulating solid dosage forms are the splitting and crushing of tablets, opening of capsules and dispersing powder in liquid or food [4]. Drug administration through enteral feeding tubes is also related to the dispersion of solid dosage forms [5]. Recommendations considering the risk of physical blockage of the feeding tube as well as the chemical compatibility of a drug product with the tube material have been published by European Medicines Agency (EMA) in a guideline on pharmaceutical development of medicines for children [6].…”

Section: Introductionmentioning

confidence: 99%

A Focus Group Study about Oral Drug Administration Practices at Hospital Wards—Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children

et al. 2020

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Oral drug administration to pediatric patients is characterized by a lack of age-appropriate drug products and the off-label use of medicines. However, drug administration practices at hospital wards is a scarcely studied subject. The aim of this study was to explore the oral drug administration practices at pediatric hospital wards, with a focus on experiences and challenges faced, methods used to mitigate existing problems, drug manipulation habits, perceptions about oral dosage forms and future needs of oral dosage forms for children. This was a qualitative study consisting of focus group discussions with physicians, nurses and clinical pharmacists in a tertiary university hospital with the objective of bringing forward a holistic view on this research topic. These healthcare professionals recognized different administration challenges that were classified as either dosage form-related or patient-related ones. A lack of depot formulations developed especially for children as well as oral pediatric dosage forms of drug substances currently available as intravenous dosage forms was recognized. The preferred oral dosage forms were oral liquids and orodispersible tablets. Patient-centered drug administration practices including factors facilitating drug administration both at hospital wards and at home after patient discharge were identified. Among all healthcare professionals, the efficient cooperation in drug prescribing and administration as well as in educating the child’s caregivers in correct administration techniques before discharge and improving the overall discharge process of patients was emphasized. This study complements the prevalent understanding that new dosage forms for children of varying ages and stages of development are still needed. It also brings a holistic view on different aspects of oral drug administration to pediatric patients and overall patient-centered drug administration practices.

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Section: Introductionmentioning

confidence: 99%

A Focus Group Study about Oral Drug Administration Practices at Hospital Wards—Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children

et al. 2020

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“…Powders divided into individual doses have traditionally been packed in small waxed papers, but even though it is no longer used, this practice is still maintained. [54] It is important to consider that crushing a solid dosage form in a mortar represents a great risk factor in the obtaining of the regularity in particle size and the homogeneity of the drug in the powder and thus a safe administration. [55] Baudrit et al…”

Section: World Journal Of Pharmaceutical Researchmentioning

confidence: 99%

“…[54] The quality controls of the formulations are carried out, as part of good manufacturing practices. [37] It is believed that the stability of drug is guaranteed for a few days, but it is necessary for the papers to fulfill the packaging function provided by the pharmacopoeias.…”

Section: World Journal Of Pharmaceutical Researchmentioning

confidence: 99%

“…This pharmaceutical form is also prepared for medicament to be administered topically, [42] as in the case of potassium permanganate powder which dissolves to form a 0,1% solution used as antiseptic and antifungal. [58] Pediatric powder papers had some synonyms like: sachet papers, [54] small paper, envelopes, pediatric pieces of paper (papelillos or papelitos in Spanish).…”

Section: World Journal Of Pharmaceutical Researchmentioning

confidence: 99%

“…Although in this manufacture there were no individual powder weights to be placed on each paper, it would not be advisable to weigh amounts below 300 mg due to the increase in the weighing error that occurs when using an analytical balance of 0,0001 g. In this sense, Sivén et al [54] recommended an optimum powder mass of 300 mg or more to decrease the quantity of drug loss during preparation and increase drug recovery. Nevertheless, it is necessary to choice excipients that no interfere in patient condition.…”

Section: World Journal Of Pharmaceutical Researchmentioning

confidence: 99%

See 2 more Smart Citations

Quality Assessment in the Extemporaneous Pediatric Preparation of Powder Papers Containing Crushed Tablets of Spironolactone or Amiodarone

Carrillo¹,

Herrera²

2017

WJPR

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To elaborate the pediatric medicines the specifics of this population must be considered. Powder papers as extemporaneous formulations may be an option to provide dosing flexibility. The main objective of this research was to evaluate the quality of powder papers in its manual preparation stages and during the 60 days of storage. The results shown that a smaller than expected mass of tablets was distributed for the 40 papers at each formulation. The precision in the distribution performed by the crushed and pulverized tablet preparatory assistant reflected relative standard deviations ranging from 9 to 15%. On the start day, the uniformity of mass showed an inaccuracy reflected in several values outside the expected range, for all formulations. The accuracy of the tablets powder mass during storage at 60 days showed a ±10% of difference respect basal mass for papers with spironolactone 6,25 mg and the 15 and 75 mg amiodarone hydrochloride papers. For 10 mg of amiodarone hydrochloride formulation, random errors occurred outside the expected ranges at two sampling times. Powder adherence percentage was between the 10 and 20%. In conclusion, the preparation of four formulations in powder paper showed some errors which resulted in a significant loss of dose. A standardized operating procedure for the preparation of powder papers should be available taking into account the risk points of the manufacturing processes. It is advisable to enable the galenical section in hospital pharmacies and to have legislation regulating extemporaneous formulations in Costa Rica.

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Rational and irrational use of nonsterile compounded medications

McBane

Coon

Anderson

et al. 2019

J Am Coll Clin Pharm

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Nonsterile compounding is a fundamental component of pharmacy practice, and compounded medications are sometimes essential to optimize a patient's medication therapy. However, controversies surround the rational use of nonsterile compounded medications. Factors including drug cost and availability and the need for a precise dosage or unique formulation may provide a legitimate reason to prepare a compounded medication. Nonetheless, clinical pharmacists should ensure a rational basis for the use of such preparations. The relative paucity of data surrounding the regulation of these formulations, as well as that surrounding their promotion and production, complicates the evaluation of their safety and efficacy. This is especially true when compounded medications are used in special cases that already lack data for the use of commercially available products. Ethical issues also surround the rational use of these nonsterile compounded medications, including the absence of their proven safety and efficacy, the lack of regulation of promotional practices regarding their use, the pricing associated with them, the strategies needed to obtain third‐party coverage for them, and the limited standards in place for the actual production of compounded medications. Indeed, more evidence documenting the safety and efficacy of compounded medications is needed, together with standardization of formulations and better regulation of promotional practices and qualifications of compounding personnel. ACCP supports increased regulation of compounding to promote the appropriate use of these preparations.

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Challenge of paediatric compounding to solid dosage forms sachets and hard capsules – Finnish perspective

Cited by 8 publications

References 19 publications

A Focus Group Study about Oral Drug Administration Practices at Hospital Wards—Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children

A Focus Group Study about Oral Drug Administration Practices at Hospital Wards—Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children

Quality Assessment in the Extemporaneous Pediatric Preparation of Powder Papers Containing Crushed Tablets of Spironolactone or Amiodarone

Rational and irrational use of nonsterile compounded medications

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