Preparation of medicines for children – A hierarchy of classification

Ernest, Terry B.; Craig, Jo; Nunn, Anthony J; Salunke, Smita; Tuleu, Catherine; Breitkreutz, Jörg; Alex, Rainer; Hempenstall, John

doi:10.1016/j.ijpharm.2012.05.070

Cited by 51 publications

(34 citation statements)

References 11 publications

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“…Namun demikian, praktik tersebut dilakukan oleh tenaga kesehatan yang ditunjuk serta sesuai dengan standar standar peracikan obat sehingga reprodusibilitas dan keamanannya terjamin. 16 Di Indonesia, praktik peracikan OAT menjadi bentuk sediaan puyer tidak melanggar regulasi yang ada, peracikan OAT diperbolehkan selama dilakukan terpisah untuk masing-masing obat.…”

Section: 16unclassified

Acceptability of Anti‑Tuberculosis Compounded Medicines at a Hospital in Bandung

Widyastiwi

Sugihartina

Pamudjo

2017

Indones J Clin Pharm

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AbstrakDi berbagai rumah sakit di Indonesia, praktik peracikan Obat Anti Tuberkulosis-Kombinasi Dosis Tetap (OAT-KDT) untuk anak dalam bentuk sediaan puyer masih dilakukan sampai saat ini. Meskipun memiliki masalah pada stabilitas dan kualitas sediaan, praktik peracikan puyer OAT tetap dilakukan sebagai upaya individualisasi dosis dan memudahkan pemberian obat pada pasien anak, sehingga diharapkan mampu meningkatkan daya terima pasien terhadap OAT. Daya terima pasien terhadap obat memiliki dampak yang signifikan terhadap kepatuhan yang akhirnya memengaruhi keberhasilan terapi. Penelitian ini bertujuan untuk mengetahui daya terima sediaan puyer racikan OAT dan keberhasilannya di salah satu rumah sakit di Bandung dan dilakukan pada bulan Maret hingga November tahun 2015. Desain penelitian adalah potong lintang dan sampel diambil dengan cara accidental sampling. Kriteria inklusi adalah pasien anak usia 0-14 tahun dengan diagnosis tuberkulosis dan menerima sediaan puyer racikan OAT. Data dikumpulkan melalui wawancara terpimpin menggunakan kuesioner tertutup yang tervalidasi dan reliabel mengenai penerimaan pasien ditinjau dari segi kepraktisan, rasa, dan bau obat. Responden adalah orang tua pasien anak sebanyak 50 orang. Hasil penelitian menunjukkan sediaan puyer racikan OAT diterima baik oleh 40,0% pasien, cukup diterima oleh 52,0% pasien, dan kurang diterima oleh 8% pasien. Faktor usia memengaruhi penerimaan pasien terhadap sediaan puyer racikan (r=0.338). Keberhasilan terapi dicapai oleh 94,6% pasien dengan lama pengobatan 6-9 bulan. Penelitian ini menghasilkan kesimpulan bahwa penggunaan sediaan puyer racikan dapat diterima baik oleh pasien dengan tingkat keberhasilan terapi yang tinggi. Sediaan puyer racikan merupakan bentuk sediaan yang disarankan untuk pasien anak karena dapat meningkatkan daya terima pasien anak terhadap OAT-KDT.Kata kunci: Daya terima, keberhasilan terapi, Obat Anti Tuberkulosis, puyer racikan Acceptability of Anti-Tuberculosis Compounded Medicines at a Hospital in Bandung AbstractIndonesian government has provided anti-TB drugs as a fixed-dose combination to eradicate tuberculosis. For pediatric patients with swallowing problems, compounded medicine is a common solution despites its stability and quality problems. Compounded medicine prescribing is intended to improve patient acceptability of medicine. Patient acceptability, especially in pediatric, will play a significant role to increase patient's adherence, and in a bigger picture, affect its efficacy. This study was aimed to determine the acceptability level of compounded medicines and its therapy outcomes at a hospital in Bandung. This study was conducted with a cross-sectional design using accidental sampling method. Inclusion criteria were pediatric patients aged 0-14 years who have diagnosed tuberculosis and received compounded medicines. Study was held in March until November 2015 at a hospital in Bandung. A valid and reliable questionnaire was provided as an instrument to interview respondents about practicality, taste, and a sme...

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Section: 16unclassified

Acceptability of Anti‑Tuberculosis Compounded Medicines at a Hospital in Bandung

Widyastiwi

Sugihartina

Pamudjo

2017

Indones J Clin Pharm

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“…Thus, these orodispersible pellets combine the advantages of both solid and liquid dosage forms and also provide technological advantages over granules, powders etc. The EMA reflection paper also proposed to consider the modification of standard technologies in the development of preferred pediatric dosage forms (EMA, 2006;Ernest et al, 2012;Slavkova and Breitkreutz, 2015). Thus, these orodispersible pellets were prepared using the technique of ExtrusionSpheronization that offers pellets with high drug loading, avoiding the coating step and is relatively economical as compared to other pelletization techniques (Ghebre- Sellassie, 1989;Erkoboni, 2003;Poddar et al, 2016;Tatavarti and Kesisoglou, 2015;Vervaet et al, 1995).…”

Section: Introductionmentioning

confidence: 99%

Novel orodispersible compositions of nutraceuticals prepared by the technology of extrusion-spheronization

2017

J App Pharma Sci

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European Medicines Agency (EMA) characterized liquid formulations as most appropriate for pediatric population but this includes drawbacks of lesser stability, more shelf space and dosing error in comparison to solid oral dosage forms. Orodispersible systems hold great promise for children as they are easy to administer, do not require additional water, are difficult to spit out, stable, thus combining advantages of solid and liquid oral dosage forms. The aim of the present research was development of orodispersible pellets of Calcium and Cholecalciferol, as nutraceuticals using the technology of Extrusion -Spheronization. Calcium deficiency is manifested in the bones and teeth of all young animal species, including humans. Effects include stunted growth, poor quality bones and teeth, bone malformation. The experimental work included optimization of the extrusion -spheronization processing parameters and choice of excipients, which critically affected the product quality to produce orodispersible pellets. The developed orodispersible pellets had satisfactory quality control parameters and formed soft palatable mass on contact with salivary fluid which could be easily swallowed. The in vitro dissolution studies indicated rapid release of active and the pellets were found to be stable. An additional advantage of these orodispersible pellets is sprinkling over soft food, juices etc for food fortification prior to administration. Key words:Orodispersible pellets, Calcium and Cholecalciferol, Extrusion -Spheronization, pediatric. INTRODUCTIONIn 2008, a WHO expert forum reviewed the existing pediatric formulations and attempted to identify future research needs to improve the development of preferred dosage forms for children. Previous references of EMA such as 'Reflection paper: formulations of choice for the pediatric population' characterized liquid formulations as most appropriate for young pediatric population (birth to eight years). Large volume doses may be inconvenient for both patient and care -giver. The reflection paper also encouraged oral multiparticulates in administering drugs to pediatrics aged 2-16 years (EMA, 2006;Batchelor et al., 2015). These can be dosed directly into the * Corresponding Author E-mail: purnima.amin @ yahoo.co.in mouth of the pediatric patient or by mixing the prescribed dose with a small amount of soft food or with a drink prior to administration. Formulations can be provided in a bottle with dosing scoop or single-dose sachets. They may also be supplied in the form of capsules, the contents of which can be sprinkled onto food. The reflection paper also discussed that orodispersible dosage forms hold great promise for children as they are easy to administer, do not require additional water and as long as dispersion is rapid, are difficult to spit out and could provide a range of dosages appropriate for use in younger children (EMA, 2006;Kristensen, 2012). The need for a multidisciplinary approach to pediatric medicines was highlighted and the potential of a ʹplatformʹ solid dosag...

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“…Approximately 80 % of all commercially available medications are not labeled for use in pediatrics, leading to unlicensed use of adult formulations for pediatric purposes (Osuntokun 2006). This 'off-label' use of medicines for pediatrics is on the rise often involving manipulation of the dosage forms intended for adult use at the point of administration to pediatrics, e.g., cutting tablets; segmenting transdermal patches; and diluting liquid dosage forms (Ernest et al 2012;Mason et al 2012). Current practice of manipulation of adult dosage forms is not supported by scientific evidence and is risky due to unpredictable pharmacokinetic and clinical outcomes (Tuleu and Breitkreutz 2013).…”

Section: Introductionmentioning

confidence: 99%

Excipients in Pediatric Formulations: Biopharmaceutical and Toxicological Considerations

Vangara¹,

Yellepeddi

2015

Excipient Applications in Formulation Design and Drug Delivery

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Excipients are commonly used in pharmaceutical formulations for a variety of applications such as solubility and stability enhancement, taste-masking, tablet compaction, etc. Excipients are also used in the preparation of pediatric formulations for purposes similar to that of adult formulations. However, excipients that are used in adult formulations may not be suitable for the development of formulations for pediatric use due to toxicity concerns. Toxicity of excipients in pediatric populations is mainly due to rapid developmental changes, slower metabolism and elimination, and varied organ and body composition. For example, solvents such as ethanol and propylene glycol that are commonly used in pediatric formulations as solubility enhancers, showed life-threatening adverse events. Therefore, it is apparent that the use of excipients in pediatric formulations requires additional risk assessment by practitioners to avoid potential toxicity issues. Regulatory agencies in the United States of America and Europe are working together to create and maintain a database of Safety and Toxicity of Excipients for Pediatrics (STEP). The purpose of this book chapter is to review the role of excipients and their toxicity in pediatric formulations along with strategies to mitigate the potential risks of toxicity associated with their use in pediatric patients.

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Preparation of medicines for children – A hierarchy of classification

Cited by 51 publications

References 11 publications

Acceptability of Anti‑Tuberculosis Compounded Medicines at a Hospital in Bandung

Acceptability of Anti‑Tuberculosis Compounded Medicines at a Hospital in Bandung

Novel orodispersible compositions of nutraceuticals prepared by the technology of extrusion-spheronization

Excipients in Pediatric Formulations: Biopharmaceutical and Toxicological Considerations

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