Introduction

Bouwman-Boer, Yvonne; Fenton-May, V’Iain; Brun, Paul Le

doi:10.1007/978-3-319-15814-3_1

Cited by 12 publications

(21 citation statements)

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“…Either way, the chosen formulation determines the quality specifications and QC analysis of the medicinal product. The Dutch Pharmacists’ Association (KNMP) published a formulary handbook (also available in English) ( Bouwman-Boer et al, 2015a ) for the formulation, compounding and QC analysis of some of the most common dosage forms (i.e. orals, rectals, parentals, dermatics, oculars and nasals).…”

Section: Formulation Developmentmentioning

confidence: 99%

“…Limits need to be specified for critical production parameters (e.g., blending, apparatus, weighing, filtration, filling, volume control) and quality parameters (e.g., appearance, content, pH, (microbiological) impurities, uniformity) to ensure the quality of the medicinal product ( Bouwman-Boer et al, 2015b ). During the product validation the impact of critical parameters on product quality has to be studied and it should be assessed whether the specified limits are set accordingly ( Bouwman-Boer et al, 2015c ).…”

Section: Quality Control Of Medicinal Productmentioning

confidence: 99%

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Pharmacy Compounded Medicines for Patients With Rare Diseases: Lessons Learned From Chenodeoxycholic Acid and Cholic Acid

2021

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Patients with rare diseases are often confronted with the fact that effective medicines are unavailable or simply not being developed. This situation jeopardizes the health of a large population of vulnerable patients with rare diseases. Pharmacy compounded formulations can provide a safe alternative when authorized treatments are unavailable or unsuitable. Practical guidelines on how to develop and implement pharmacy compounded formulations for patients with rare diseases are limited. The aim of this article is to provide guidance for when and how to apply pharmacy compounded formulations for patients with rare diseases. This is illustrated with two challenging examples: the development and implementation of pharmacy compounding of 1) chenodeoxycholic acid (CDCA) capsules for patients with cerebrotendinous xanthomatosis (CTX) and 2) cholic acid (CA) capsules for patients with rare bile acid synthesis defects (BASD). All critical steps of the development of CDCA and CA capsules are explained and summarized in a practical guideline.

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Section: Formulation Developmentmentioning

confidence: 99%

Section: Quality Control Of Medicinal Productmentioning

confidence: 99%

Pharmacy Compounded Medicines for Patients With Rare Diseases: Lessons Learned From Chenodeoxycholic Acid and Cholic Acid

2021

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“…Another compound, benzalkonuim chloride, induces a slow, but irreversible, ciliotoxic effect. It also has the capacity to slow down CBF and disorganize the mucus structure through electrostatic interactions with anionic substances [ 172 ]. Mucociliary clearance constituted one of the extracellular barriers for gene transfer.…”

Section: Cellular Models For Gene Transfer Evaluationmentioning

confidence: 99%

Optimizations of In Vitro Mucus and Cell Culture Models to Better Predict In Vivo Gene Transfer in Pathological Lung Respiratory Airways: Cystic Fibrosis as an Example

et al. 2020

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The respiratory epithelium can be affected by many diseases that could be treated using aerosol gene therapy. Among these, cystic fibrosis (CF) is a lethal inherited disease characterized by airways complications, which determine the life expectancy and the effectiveness of aerosolized treatments. Beside evaluations performed under in vivo settings, cell culture models mimicking in vivo pathophysiological conditions can provide complementary insights into the potential of gene transfer strategies. Such models must consider multiple parameters, following the rationale that proper gene transfer evaluations depend on whether they are performed under experimental conditions close to pathophysiological settings. In addition, the mucus layer, which covers the epithelial cells, constitutes a physical barrier for gene delivery, especially in diseases such as CF. Artificial mucus models featuring physical and biological properties similar to CF mucus allow determining the ability of gene transfer systems to effectively reach the underlying epithelium. In this review, we describe mucus and cellular models relevant for CF aerosol gene therapy, with a particular emphasis on mucus rheology. We strongly believe that combining multiple pathophysiological features in single complex cell culture models could help bridge the gaps between in vitro and in vivo settings, as well as viral and non-viral gene delivery strategies.

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“… 8 The results from the section “Stability of apomorphine HCl in antioxidant solutions” supported this description where the yellow colored 50 μg/mL apomorphine HCl solution (in 0.1% SMB solution) was first observed on Day 11, Day 5, and Day 3 at 25°C, 32°C, and 37°C, respectively. Thus, we propose that the yellowish or brownish compound formation in 50 μg/mL apomorphine HCl in 0.1% AA solution or 0.1% AA plus 0.1% EDTA solution may be attributed to either the degradant(s) of AA 16 , 17 or a product of reactions between AA and apomorphine HCl. It could also be the phenanthrene degradation product of apomorphine reported by Udvardy et al 1 As expected, the rate of degradation of apomorphine HCl (in all antioxidant solutions) increased with temperature, as shown by Wilcox et al 9 previously.…”

Section: Discussionmentioning

confidence: 93%

Stability of apomorphine in solutions containing selected antioxidant agents

Ang¹,

Boddy²,

Liu³

et al. 2016

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Apomorphine in solution undergoes rapid autoxidation, producing greenish colored solutions, making it difficult to formulate as a stable pharmaceutical solution. To identify the optimum antioxidant agent/combination for apomorphine solution, a high performance liquid chromatography assay was used to study the stability of 50 μg/mL apomorphine HCI in 0.1% L-ascorbic acid (AA), 0.1% sodium metabisulfite (SMB), 0.1% EDTA, and in selected combinations at 25°C, 32°C, and 37°C over a period of 14 days. The stability of apomorphine HCl (10 mg/mL) in 0.1% AA solution and in 0.1% EDTA solution at 25°C and 37°C was also evaluated. Apomorphine HCI solution (50 μg/mL) in 0.1% AA plus 0.1% SMB solution retained 99.7% (at 25°C) and 95.9% (at 37°C) of the initial concentration, as 0.1% AA plus SMB solution minimized the reactive oxygen content in solution which, in turn, reduced the oxidation rate of apomorphine HCl, and there was no green coloration perceptible. Conversely, apomorphine HCl solution (50 μg/mL) in 0.1% SMB solution was unstable as only 0.53% (at 25°C) and 0.06% (at 37°C) of the initial concentration was retained after 14 days. All 10 mg/mL apomorphine HCl samples were stable in both studies. The initial concentration of apomorphine HCl solution markedly affected its rate of oxidation and discoloration. The addition of 0.1% AA to a current formulation of apomorphine HCl injection (Apomine®), which contains SMB as an antioxidant, was recommended as providing the most stable solution.

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Introduction

Cited by 12 publications

References 0 publications

Pharmacy Compounded Medicines for Patients With Rare Diseases: Lessons Learned From Chenodeoxycholic Acid and Cholic Acid

Pharmacy Compounded Medicines for Patients With Rare Diseases: Lessons Learned From Chenodeoxycholic Acid and Cholic Acid

Optimizations of In Vitro Mucus and Cell Culture Models to Better Predict In Vivo Gene Transfer in Pathological Lung Respiratory Airways: Cystic Fibrosis as an Example

Stability of apomorphine in solutions containing selected antioxidant agents

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