Critical appraisal of commercially available suspending vehicles for extemporaneous compounding of cardiovascular medicines: physical and chemical stability mini review

Thrimawithana, Thilini; D’Amore, Sebastian; Dib, Youseph; Firooz, Nazanin Fadavi; Fakhouri, Wafaa; Saeed, Athraa; Allahham, Ayman

doi:10.1080/10837450.2018.1526955

Cited by 4 publications

(5 citation statements)

References 20 publications

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“…Oral pediatric extemporaneous preparations are common especially in developing countries such as Kenya, Nigeria and Ethiopia. Stability studies have been performed on some of the pediatric formulations (Lin et al, 2021;Silva et al, 2020;Thrimawithana et al, 2018;Glass & Haywood, 2006). Results of a review on stability of 28 oral pediatric extemporaneous preparations in Ethiopia showed that most formulations were chemically, physically, and microbiologically stable and retained more than 90% of the initial content (Belayneh & Tessema, 2021).…”

Section: Quality Assurance Of Extemporaneous Preparationsmentioning

confidence: 99%

Extemporaneous Compounding: Prevalence, Risks and Quality Assurance

Vugigi

2023

AJPAM

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Extemporaneously compounded products are designed for an individual patient based on a licensed physician’s prescription in response to an identified need. Compounding provides medications for unique medical needs for which commercially manufactured products are unavailable. Compounding practice includes activities such as formulating, mixing, or repacking products. Extemporaneous preparations are not licensed by Drug Regulatory Authorities and hence, are not evaluated for quality, efficacy, and stability. Also, adverse event reporting is not mandatory for these products. The need for extemporaneous preparations is precipitated by a lack of commercially available products for all the medicines and dosage forms that are required by patients. Products intended for topical and pediatric use are the majority. Extemporaneous preparations are generally considered as high-risk products. Common risks of compounded products include calculation errors, microbial contamination, therapeutic failure, and adverse reactions. To reduce the risks, Drug Regulatory Authorities havedeveloped guidelines that describe the minimum standards to be followed when preparing for extemporaneous compounding to ensure product quality and fitness. A comprehensive assessment is performed to justify the need for these products. The preparation process should comply with all the Good Manufacturing Practices including design of compounding areas. Pharmacists performing compounding activities require appropriate knowledge, skills, and competence to undertake the task. The ingredients used in compounding are subject to pharmacopeial quality standards and should be sourced from approved vendors. The final compounded product in some countries is controlled as stipulated in the components standard. Extemporaneous compounding remains an important part of pharmacy practice. Comprehensive risk assessment, adherence to the prescribed manufacturing practices, and use of national formularies are necessary for quality assurance of these preparations.

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Section: Quality Assurance Of Extemporaneous Preparationsmentioning

confidence: 99%

Extemporaneous Compounding: Prevalence, Risks and Quality Assurance

Vugigi

2023

AJPAM

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“…An advantage of modern suspending bases would be the compounding technique and the stability provided by the manufacturer. This topic has also been considered by Thrimawithana et al, comparing the classical and modern suspending bases, and concluded that there are APIs for which traditional compounding was more suitable [115].…”

Section: Stability Study Designmentioning

confidence: 99%

Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient’s Safety—A Narrative Review

et al. 2023

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The development of safe and effective pediatric formulations is essential, especially in therapeutic areas such as pediatric cardiology, where the treatment requires multiple dosing or outpatient care. Although liquid oral dosage forms are considered the formulation of choice given the dose flexibility and acceptability, the compounding practices are not endorsed by the health authorities, and achieving stability can be problematic. The purpose of this study is to provide a comprehensive overview of the stability of liquid oral dosage forms used in pediatric cardiology. An extensive review of the literature has been performed, with a particular focus on cardiovascular pharmacotherapy, by consulting the current studies indexed in PubMed, ScienceDirect, PLoS One, and Google Scholar databases. Regulations and guidelines have been considered against the studies found in the literature. Overall, the stability study is well-designed, and the critical quality attributes (CQAs) have been selected for testing. Several approaches have been identified as innovative in order to optimize stability, but opportunities to improve have been also identified, such as in-use studies and achieving dose standardization. Consequently, the information gathering and the results of the studies can be translated into clinical practice in order to achieve the desired stability of liquid oral dosage forms.

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“…Captopril , [ 4 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 ] is an angiotensin I-converting enzyme inhibitor (ACE-I) indicated in the treatment of heart failure and hypertension [ 34 , 35 , 36 ]. It is a BCS class I agent and is freely soluble in water (160 mg/mL), although its stability is limited due to disulfide formation.…”

Section: The Next Wave Of Oral Liquid Formulation Development—formula...mentioning

confidence: 99%

“…Amiodarone is available in a 50 mg/mL intravenous injection, exhibits 0.72 mg/mL solubility in water, and is highly lipophilic. A 5 mg/mL formulation at pH = 4 with cherry flavoring has been suggested [ 33 ].…”

Section: The Next Wave Of Oral Liquid Formulation Development—formula...mentioning

confidence: 99%

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

Parrish

Ashworth²,

Löbenberg

et al. 2022

Pharmaceutics

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The purpose of this work was to evaluate the suitability of recent US Food and Drug Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms, and to propose lists of compounded nonsterile preparations (CNSPs) that should be developed as commercially available FDA-approved finished liquid dosage forms, as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and professionals are encouraged to continue to work together to improve the likelihood that patients will receive high-quality standardized extemporaneously compounded CNSPs and US-FDA-approved products.

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Critical appraisal of commercially available suspending vehicles for extemporaneous compounding of cardiovascular medicines: physical and chemical stability mini review

Cited by 4 publications

References 20 publications

Extemporaneous Compounding: Prevalence, Risks and Quality Assurance

Extemporaneous Compounding: Prevalence, Risks and Quality Assurance

Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient’s Safety—A Narrative Review

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

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