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48 pages, 1556 KiB  
Review
Extemporaneous Compounding, Pharmacy Preparations and Related Product Care in the Netherlands
by Herman J. Woerdenbag, Boy van Basten, Christien Oussoren, Oscar S. N. M. Smeets, Astrid Annaciri-Donkers, Mirjam Crul, J. Marina Maurer, Kirsten J. M. Schimmel, E. Marleen Kemper, Marjolijn N. Lub-de Hooge, Nanno Schreuder, Melissa Eikmann, Arwin S. Ramcharan, Richard B. Lantink, Julian Quodbach, Hendrikus H. Boersma, Oscar Kelder, Karin H. M. Larmené-Beld, Paul P. H. Le Brun, Robbert Jan Kok, Reinout C. A. Schellekens, Oscar Breukels, Henderik W. Frijlink and Bahez Garebadd Show full author list remove Hide full author list
Pharmaceutics 2025, 17(8), 1005; https://doi.org/10.3390/pharmaceutics17081005 - 31 Jul 2025
Viewed by 259
Abstract
Background/Objectives: In many parts of the world, pharmacists hold the primary responsibility for providing safe and effective pharmacotherapy. A key aspect is the availability of appropriate medicines for each individual patient. When industrially manufactured medicines are unsuitable or unavailable, pharmacists can prepare [...] Read more.
Background/Objectives: In many parts of the world, pharmacists hold the primary responsibility for providing safe and effective pharmacotherapy. A key aspect is the availability of appropriate medicines for each individual patient. When industrially manufactured medicines are unsuitable or unavailable, pharmacists can prepare tailor-made medicines. While this principle applies globally, practices vary between countries. In the Netherlands, the preparation of medicines in pharmacies is well-established and integrated into routine healthcare. This narrative review explores the role and significance of extemporaneous compounding, pharmacy preparations and related product care in the Netherlands. Methods: Pharmacists involved in pharmacy preparations across various professional sectors, including community and hospital pharmacies, central compounding facilities, academia, and the professional pharmacists’ organisation, provided detailed and expert insights based on the literature and policy documents while also sharing their critical perspectives. Results: We present arguments supporting the need for pharmacy preparations and examine their position and role in community and hospital pharmacies in the Netherlands. Additional topics are discussed, including the regulatory and legal framework, outsourcing, quality assurance, standardisation, education, and international context. Specific pharmacy preparation topics, often with a research component and a strong focus on product care, are highlighted, including paediatric dosage forms, swallowing difficulties and feeding tubes, hospital-at-home care, reconstitution of oncolytic drugs and biologicals, total parenteral nutrition (TPN), advanced therapy medicinal products (ATMPs), radiopharmaceuticals and optical tracers, clinical trial medication, robotisation in reconstitution, and patient-centric solid oral dosage forms. Conclusions: The widespread acceptance of pharmacy preparations in the Netherlands is the result of a unique combination of strict adherence to tailored regulations that ensure quality and safety, and patient-oriented flexibility in design, formulation, and production. This approach is further reinforced by the standardisation of a broad range of formulations and procedures across primary, secondary and tertiary care, as well as by continuous research-driven innovation to develop new medicines, formulations, and production methods. Full article
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16 pages, 577 KiB  
Review
Personalized Neonatal Therapy: Application of Magistral Formulas in Therapeutic Orphan Populations
by Wenwen Shao, Angela Gomez, Alejandra Alejano, Teresa Gil and María Cristina Benéitez
Pharmaceutics 2025, 17(8), 963; https://doi.org/10.3390/pharmaceutics17080963 - 25 Jul 2025
Viewed by 340
Abstract
This review explores the potential of magistral formulas (MFs) as a viable option to meet the needs of neonates, given the lack of adequate therapies for this vulnerable group. The scientific literature on medicines available for neonates is limited. The physiological differences between [...] Read more.
This review explores the potential of magistral formulas (MFs) as a viable option to meet the needs of neonates, given the lack of adequate therapies for this vulnerable group. The scientific literature on medicines available for neonates is limited. The physiological differences between neonates and adults make it difficult to formulate these medicines. In addition, there are a variety of difficulties in conducting research on neonates: few clinical trials are performed, and there is frequent use of unauthorized medicines. Pharmacokinetics in neonates was investigated in comparison to adults, and different aspects of the absorption, distribution, metabolism, and excretion were observed. One of the main problems is the different pharmacokinetics between the two populations. It is necessary to promote and allow research related to pediatric drug design, approve a specific authorization for use in age-appropriate dosage forms, and improve the quality and availability of information on drugs. This study focused on the MFs typically used for pediatrics, specifically for neonates, analyzing the pharmaceutical forms currently available and the presence of indications and dosage recommendations of the European Medicines Agency. Medications were classified according to therapeutic group, as antihypertensives, corticosteroids, and antiepileptics. The use of off-label medicines remains high in neonatal intensive care units and in primary healthcare, besides in the preparation of MFs by pharmacists. The shortage of medicines specifically designed and approved for neonates is a serious problem for society. Neonates continue to be treated, on numerous occasions, with off-label medicines. Studies and research should be expanded in this vulnerable population group. Full article
(This article belongs to the Section Pharmaceutical Technology, Manufacturing and Devices)
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15 pages, 741 KiB  
Article
Development of Nifedipine Phytantriol-Based Cubosomes and In Vitro Simulation of Administration Through Pediatric Feeding Tubes
by Lorena Almeida Lima, Euler Eduardo Lisboa de Moura, Schauana Freitas Fraga, Renata Vidor Contri and Irene Clemes Külkamp-Guerreiro
Pharmaceutics 2025, 17(7), 828; https://doi.org/10.3390/pharmaceutics17070828 - 25 Jun 2025
Viewed by 388
Abstract
Background/Objectives: This study focused on developing an organic solvent-free formulation of phytantriol-based cubosomes for nifedipine delivery. It assessed the physicochemical properties and in vitro administration performance in pediatric nasogastric tubes and preliminarily evaluated toxicity in a brine shrimp lethality model. Methods: The nanocarrier [...] Read more.
Background/Objectives: This study focused on developing an organic solvent-free formulation of phytantriol-based cubosomes for nifedipine delivery. It assessed the physicochemical properties and in vitro administration performance in pediatric nasogastric tubes and preliminarily evaluated toxicity in a brine shrimp lethality model. Methods: The nanocarrier formulation was characterized in terms of the particle size and drug release properties and was compared with extemporaneous formulations prepared using nifedipine tablets in flow rate tests through pediatric feeding tubes. The recovery efficiency was evaluated across different tube sizes and rinsing volumes. A preliminary toxicity study was conducted using a brine shrimp lethality model. Results: Compared with nifedipine tablets, the nanocarrier formulation demonstrated favorable physicochemical properties, including controlled release and superior flow rates, in the pediatric tubes. Full recovery of the nifedipine content was achieved with the nanocarrier formulation, whereas extemporaneous formulation of the nifedipine recovery depended on the tube dimensions and rinsing protocols. Conclusions: Compared with the traditional formulations, the nanocarrier formulation represents a promising alternative for administering nifedipine via pediatric feeding tubes, offering an enhanced administration recovery. Full article
(This article belongs to the Special Issue Customized Pharmaceutics: Innovations for Diverse Populations)
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25 pages, 2811 KiB  
Review
68Ga Extemporaneous Preparations in Radiopharmacy
by Marzia Rizzello, Anna Pacelli, Maria Domenica De Bari, Annalisa Cutrignelli, Rosa Maria Iacobazzi, Antonio Lopalco and Nunzio Denora
Pharmaceutics 2025, 17(7), 802; https://doi.org/10.3390/pharmaceutics17070802 - 20 Jun 2025
Viewed by 670
Abstract
Gallium-68 (68Ga) radiopharmaceuticals are increasingly used in nuclear medicine due to their rapid production capabilities and exceptional specificity in molecular imaging applications. Several of these tracers have demonstrated remarkable clinical efficacy across various oncological conditions, including prostate cancer, neuro-endocrine tumours, and [...] Read more.
Gallium-68 (68Ga) radiopharmaceuticals are increasingly used in nuclear medicine due to their rapid production capabilities and exceptional specificity in molecular imaging applications. Several of these tracers have demonstrated remarkable clinical efficacy across various oncological conditions, including prostate cancer, neuro-endocrine tumours, and cancers expressing fibroblast activation protein. Commercial kits allow the use of the standardised production protocol, but extemporaneous preparations are the economic and flexible alternatives, particularly within hospital-based radiopharmacy settings. However, such preparations need meticulous conformity to quality control measures and regulation to ensure safety and effectiveness. This review provides an analysis of current methodologies employed in 68Ga extemporaneous preparations and examines pertinent regulatory frameworks. Further clinical validation trials and technical advancement remain essential to facilitate the routine clinical practice’s widespread usage and long-term feasibility of such preparations. Full article
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18 pages, 1317 KiB  
Article
Stability Assessment of Furosemide Oral Suspension in Hospital Extemporaneous Preparations
by Fai Alkathiri, Omamah Eid, Njoud Altuwaijri, Rihaf Alfaraj, Eram K. Eltahir, Hend Alsabbagh, Shamma Bin Shoia, Mashal Aljead, Haya H. Alnufaie and Ghadah AlToum
Pharmaceuticals 2025, 18(7), 937; https://doi.org/10.3390/ph18070937 - 20 Jun 2025
Viewed by 542
Abstract
Background: Furosemide is a loop diuretic used extensively to treat adult and pediatric patients. In some hospitals, furosemide oral liquids are not available in stock, thus necessitating the extemporaneous preparation of the drug. This study evaluates the stability of on-the-spot formulations of furosemide [...] Read more.
Background: Furosemide is a loop diuretic used extensively to treat adult and pediatric patients. In some hospitals, furosemide oral liquids are not available in stock, thus necessitating the extemporaneous preparation of the drug. This study evaluates the stability of on-the-spot formulations of furosemide oral suspensions from crushed tablets evaluated in various vehicles: Dextrose 50%, Dextrose 70%, Ora-Sweet, and Ora-Plus over 60 days. This examination was prompted by the frequent shortage of certain excipients in the hospital, leading to the need to switch to Dextrose 50% or Dextrose 70% when Ora-Sweet and Ora-Plus are out of stock. Methods: The extemporaneous furosemide oral suspensions were prepared following the same compounding method used in the pharmacy. The suspensions were maintained at 4 °C in the refrigerator and assessed immediately and later, on days 7, 14, 30, and 60. The assessed parameters included visual appearance, redispersion time, sedimentation volume, and pH levels for stability analysis. We also examined the drug content, dissolution of the suspension, and microbiological stability. Results: Initial examinations indicated that Dextrose 50% and Ora-Plus maintained pH levels and stable appearances, while significant changes, mainly in appearance and redispersion time, indicated the instability of Dextrose 70%. Ora-Sweet showed fluctuations but stabilized by day 30. Dissolution studies demonstrated that Ora-Plus had dissolution characteristics superior to the other formulations, while Dextrose 50% showed declining dissolution percentages over time. Overall, the Ora-Plus vehicle showed superior stability (60 days), followed by Ora-Sweet (30 days), while Dextrose 70% and Dextrose 50% showed shorter stability durations of 14 and 7 days, respectively. The microbiological test results showed no microbial growth. Conclusions: This study demonstrates that the vehicle used in extemporaneous furosemide suspensions critically affects their stability and performance. Ora-Plus emerged as the most suitable vehicle, maintaining physical, chemical, and microbiological stability over 60 days, with consistent pH, redispersion, and dissolution behavior. Ora-Sweet showed intermediate stability (30 days), while Dextrose 50% and 70% exhibited early instability—7 and 14 days, respectively—marked by sedimentation, poor redispersibility, and declining drug release. These findings underscore the importance of vehicle selection and regular stability monitoring in compounded formulations to ensure therapeutic reliability and patient safety. Full article
(This article belongs to the Section Pharmaceutical Technology)
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13 pages, 1974 KiB  
Article
In Vitro Percutaneous Absorption of Permeation-Enhancing Estrogen Formulations
by Guiyun Song, Kendice Ip, Bruce Biundo, Maria Carvalho, A. J. Day, August S. Bassani, Hui Song, Benigno C. Valdez and Daniel Banov
Pharmaceuticals 2025, 18(4), 596; https://doi.org/10.3390/ph18040596 - 19 Apr 2025
Viewed by 861
Abstract
Background/Objectives: Hormone Replacement Therapy (HRT) is commonly prescribed to women in need to restore the deficiency of hormones. Estrogens, in particular estradiol (E2) and estriol (E3), are associated with side effects when given orally. As such, estrogen is topically applied on the [...] Read more.
Background/Objectives: Hormone Replacement Therapy (HRT) is commonly prescribed to women in need to restore the deficiency of hormones. Estrogens, in particular estradiol (E2) and estriol (E3), are associated with side effects when given orally. As such, estrogen is topically applied on the skin for the delivery of the hormone. The objective of this in vitro study is to evaluate the percutaneous absorption of compounded estradiol 0.06% and bi-est E3/E2 0.1%/0.06% in aqueous and anhydrous proprietary permeation-enhancing bases, in comparison with the commercially available estradiol transdermal gel (ESTROGel®). Methods: The In Vitro Permeation Test (IVPT) was used and validated for the objectives of this study. The strength of estradiol/estriol in five test formulations was determined using Ultra Performance Liquid Chromatography (UPLC). Results: ESTROGel exhibited a rapid increase in the rate of skin absorption of estradiol within 0.5 h post-application. This peak was followed by a rapid decline in flux within 4 h, and then a slower decline by 16 h post-application. The initial rapid increase for ESTROGel was much faster than the rate of the four test compounded formulations, which each exhibited a slow and steady increase in the rate of skin absorption of estradiol with a peak flux within 6 h, and a steady absorption within 16 h of application. Conclusions: The compounded bases facilitated a steady percutaneous absorption of estradiol, without quick peaking or declining, which is one of the desired characteristics in HRT. Compounding pharmacists and practitioners may consider estradiol compounded formulations as a viable option for hormone delivery to patients. Full article
(This article belongs to the Topic Personalized Drug Formulations)
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14 pages, 3645 KiB  
Article
Toward the Optimal Choice of Gelled Vehicles for Oral Drug Administration in Dysphagic Patients
by Serena Logrippo, Roberta Ganzetti, Matteo Sestili, Diego Romano Perinelli, Marco Cespi and Giulia Bonacucina
Pharmaceutics 2025, 17(2), 251; https://doi.org/10.3390/pharmaceutics17020251 - 14 Feb 2025
Viewed by 709
Abstract
Background/Objectives: Thickened waters are commonly used for dysphagic patients to ensure hydration, facilitate safer swallowing, and administer oral therapies, yet their impact on drug dissolution remains unclear. This study aims to investigate how thickening agents, viscosity, and solid oral dosage form (SODF) [...] Read more.
Background/Objectives: Thickened waters are commonly used for dysphagic patients to ensure hydration, facilitate safer swallowing, and administer oral therapies, yet their impact on drug dissolution remains unclear. This study aims to investigate how thickening agents, viscosity, and solid oral dosage form (SODF) formulations influence drug release in gelled vehicles. Methods: Twelve commercially available thickened waters, including both ready-to-use products and powders for extemporaneous preparation, were used to disperse crushed sodium pravastatin tablets. The resulting preparations were evaluated for their rheological properties and dissolution performance. Results: Thickened water products vary in consistency, with starch-based thickeners providing more consistent results than gum-based ones. Pravastatin release profiles closely matched the original tablets with starch thickeners, while gum-based thickeners showed greater variability, primarily influenced by viscosity. Conclusions: These findings emphasize the importance of selecting the appropriate thickening agent for controlling drug release in thickened water products, highlighting the need to balance patient compliance with the potential impact on drug release during product development. Full article
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13 pages, 1536 KiB  
Article
Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma
by Chiara Lacassia, Annalisa Cutrignelli, Flavia Maria la Forgia, Sergio Fontana, Antonio Lopalco, Nunzio Denora and Angela Assunta Lopedota
Pharmaceutics 2025, 17(1), 83; https://doi.org/10.3390/pharmaceutics17010083 - 10 Jan 2025
Cited by 1 | Viewed by 980
Abstract
Background/Objectives: Since 2008, following clinical studies conducted on children that revealed the ability of the β-adrenergic antagonist propranolol to inhibit capillary growth in infantile hemangiomas (IHs), its oral administration has become the first-line treatment for IHs. Although oral propranolol therapy at a [...] Read more.
Background/Objectives: Since 2008, following clinical studies conducted on children that revealed the ability of the β-adrenergic antagonist propranolol to inhibit capillary growth in infantile hemangiomas (IHs), its oral administration has become the first-line treatment for IHs. Although oral propranolol therapy at a dosage of 3 mg/kg/die is effective, it can cause systemic adverse reactions. This therapy is not necessarily applicable to all patients. Topical skin applications could help maintain a high drug concentration at local sites and also represent a characteristically easy method of administration for pediatric patients. Because no topical propranolol dosage forms are commercially available, such formulations may be prepared at hospitals and pharmacies. Methods: In the present study, we identified a simple method for preparing topical propranolol hydrochloride formulations at 1% w/w with five commercial ready-to-use bases and evaluated the pharmaceutical profiles. The physical stability of the extemporaneous formulations was predicted by performing an accelerated centrifuge test and assessed by visual inspection after one month storage at 25 °C. The chemical stability of the drug in the five formulations was assessed by using a high-performance liquid chromatography (HPLC) method. In vitro drug-release and permeability experiments were conducted through synthetic membranes and the outer pavilion of a pig’s ear by utilizing Franz-type diffusion cells. Results: The results indicated that the release of the drug was significantly influenced by the internal structure and physicochemical properties of each base. Conclusions: Specifically, the formulations prepared with the hydrophilic bases could be easily prepared and yield satisfactory results, representing a potential effective therapy for IHs in pediatric patients. Full article
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20 pages, 2143 KiB  
Article
Thermosensitive In Situ Ophthalmic Gel for Effective Local Delivery and Antifungal Activity of Ketoconazole Nanoparticles
by Chutima Chaiwut, Sarin Tadtong, Puriputt Akachaipaibul, Jutamas Jiaranaikulwanitch, Sudarshan Singh, Siriporn Okonogi, Dwi Marlina Syukri and Chuda Chittasupho
Gels 2025, 11(1), 13; https://doi.org/10.3390/gels11010013 - 27 Dec 2024
Cited by 4 | Viewed by 1387
Abstract
Fungal keratitis is a severe ocular infection caused by pathogenic fungi, leading to potential vision loss if untreated. Current antifungal treatments face limitations such as low solubility, poor corneal penetration, and limited therapeutic options. This study aimed to develop a thermosensitive in situ [...] Read more.
Fungal keratitis is a severe ocular infection caused by pathogenic fungi, leading to potential vision loss if untreated. Current antifungal treatments face limitations such as low solubility, poor corneal penetration, and limited therapeutic options. This study aimed to develop a thermosensitive in situ gel incorporating ketoconazole nanoparticles (NPs) to enhance drug solubility, stability, and antifungal activity. Ketoconazole NPs were prepared using the solvent displacement method, achieving a particle size of 198.25 ± 27.51 nm, encapsulation efficiency of 94.08 ± 0.51%, polydispersity index of 0.42 ± 0.08, and a positive zeta potential value of +10.08 ± 0.19 mV. The NPs exhibited sustained zero-order release kinetics. The optimized NPs were incorporated into a poloxamer-based in situ gel, demonstrating a gelation temperature of 34.67 ± 0.58 °C and the shortest gelation time. The formulation provided a 5-fold increase in solubility and a 10-fold improvement in drug release compared to pure ketoconazole. Stability studies confirmed the gel retained its physicochemical and rheological properties for three months under various storage conditions. The in situ gel showed sustained release, effective antifungal activity against Malassezia furfur, and good tolerability, suggesting it as a promising alternative for treating fungal keratitis with improved bioavailability and patient compliance. Full article
(This article belongs to the Special Issue Recent Advances in Gels Engineering for Drug Delivery (2nd Edition))
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14 pages, 4946 KiB  
Article
Pediatric Orally Disintegrating Tablets (ODTs) with Enhanced Palatability Based on Propranolol HCl Coground with Hydroxypropyl-β-Cyclodextrin
by Marzia Cirri, Paola A. Mura, Francesca Maestrelli, Simona Benedetti and Susanna Buratti
Pharmaceutics 2024, 16(11), 1351; https://doi.org/10.3390/pharmaceutics16111351 - 23 Oct 2024
Cited by 2 | Viewed by 1958
Abstract
Background: Propranolol, largely prescribed as an antihypertensive and antiarrhythmic drug in pediatrics, is characterized by a bitter taste and an astringent aftertaste. Currently, the therapy requires crushing of tablets for adults and their dispersion in water many times a day, leading to loss [...] Read more.
Background: Propranolol, largely prescribed as an antihypertensive and antiarrhythmic drug in pediatrics, is characterized by a bitter taste and an astringent aftertaste. Currently, the therapy requires crushing of tablets for adults and their dispersion in water many times a day, leading to loss of dosing accuracy, low palatability, and poor compliance for both patients and caregivers. Objectives: This work aimed to exploit cyclodextrin complexation by cogrinding to develop orally disintegrating tablets (ODTs) endowed with reliable dosing accuracy, good palatability and safety, ease of swallowability, and ultimately better compliance for both pediatric patients and caregivers. Results: Different formulation variables and process parameters were evaluated in preparing ODTs. The technological and morphological characterization and disintegration tests were performed according to official and alternative tests to select the ODT formulation based on the drug Hydroxypropyl-β-cyclodextrin (HPβCD) coground complex form containing Pearlitol® Flash as the diluent and 8% Explotab® as the superdisintegrant, which demonstrated the highest % drug dissolution in simulated saliva and acceptable in vitro palatability assessed by the electronic tongue, confirming the good taste-masking power of HPβCD towards propranolol. Conclusions: Such a new dosage form of propranolol could represent a valid alternative to the common extemporaneous preparations, overcoming the lack of solid formulations of propranolol intended for pediatric use. Full article
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15 pages, 3504 KiB  
Article
Liquid- and Semisolid-Filled Hard Gelatin Capsules Containing Alpha-Lipoic Acid as a Suitable Dosage Form for Compounding Medicines and Dietary Supplements
by Jelena Jovičić-Bata, Nemanja Todorović, Veljko Krstonošić, Ivan Ristić, Zorana Kovačević, Milana Vuković and Mladena Lalić-Popović
Pharmaceutics 2024, 16(7), 892; https://doi.org/10.3390/pharmaceutics16070892 - 4 Jul 2024
Cited by 1 | Viewed by 2627
Abstract
Liquid-filled hard gelatin capsules may have pertinent advantages both for therapeutic effect and extemporaneous preparations of medicines. Alpha lipoic acid is a substance used in medicines and dietary supplements and there is a need for creating an appropriate formulation which would be suitable [...] Read more.
Liquid-filled hard gelatin capsules may have pertinent advantages both for therapeutic effect and extemporaneous preparations of medicines. Alpha lipoic acid is a substance used in medicines and dietary supplements and there is a need for creating an appropriate formulation which would be suitable for each individual patient or consumer. Based on its biopharmaceutical and physical chemical characteristics, eight different capsule formulations were designed and characterized. Silicon dioxide was added to form a semisolid content and prevent leakage. The formulation filled with alpha lipoic acid solution in polyethylene glycol 400 showed the best performance. Although the addition of silicon dioxide to the formulation with polyethylene glycol 400 led to a change in both flow character and viscosity, the release rate did not show a statistically significant decrease (more than 85% of content was released after 5 min testing). Applied technique is a simple and an appropriate approach for compounding and could be used for other substances with similar properties. Full article
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28 pages, 16246 KiB  
Article
Automated Non-Sterile Pharmacy Compounding: A Multi-Site Study in European Hospital and Community Pharmacies with Pediatric Immediate Release Propranolol Hydrochloride Tablets
by Niklas Sandler Topelius, Farnaz Shokraneh, Mahsa Bahman, Julius Lahtinen, Niko Hassinen, Sari Airaksinen, Soumya Verma, Ludmila Hrizanovska, Jana Lass, Urve Paaver, Janika Tähnas, Catharina Kern, Frederic Lagarce, Dominic Fenske, Julia Malik, Holger Scherliess, Sara P. Cruz, Mattias Paulsson, Jan Dekker, Katja Kammonen, Maria Rautamo, Hendrik Lück, Antoine Pierrot, Stephanie Stareprawo, Marija Tubic-Grozdanis, Stefanie Zibolka, Uli Lösch, Martina Jeske, Ulrich Griesser, Karin Hummer, Andreas Thalmeier, Anna Harjans, Alexander Kruse, Ralph Heimke-Brinck, Karim Khoukh and Fabien Brunoadd Show full author list remove Hide full author list
Pharmaceutics 2024, 16(5), 678; https://doi.org/10.3390/pharmaceutics16050678 - 17 May 2024
Cited by 11 | Viewed by 3697
Abstract
Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and [...] Read more.
Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend® excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies. Full article
(This article belongs to the Section Pharmaceutical Technology, Manufacturing and Devices)
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16 pages, 4555 KiB  
Article
Development and Implementation of an Ultraviolet-Dye-Based Qualification Procedure for Hand Washing and Disinfection to Improve Quality Assurance of Pharmacy Preparations and Compounding, Especially in Cleanrooms: A Pilot Study
by Catharina W. J. Knol, Paul H. Stob and Herman J. Woerdenbag
Pharmacy 2024, 12(3), 73; https://doi.org/10.3390/pharmacy12030073 - 25 Apr 2024
Viewed by 2998
Abstract
Even though, nowadays, most medicines are manufactured industrially, patients may have medical needs that can only be met by a tailor-made approach. This requires the availability of pharmacy preparations made under Good Manufacturing Practice (GMP) conditions. An efficient hand hygiene practice is essential [...] Read more.
Even though, nowadays, most medicines are manufactured industrially, patients may have medical needs that can only be met by a tailor-made approach. This requires the availability of pharmacy preparations made under Good Manufacturing Practice (GMP) conditions. An efficient hand hygiene practice is essential herewith, especially if sterile products that are prepared in a cleanroom are concerned. The effectiveness of hand washing and hand disinfection procedures greatly relies on adequate training. We carried out an observational cross-sectional pilot study aimed at optimizing hand hygiene training with objective and measurable quality assessments using an ultraviolet (UV) dye. Practical acceptance criteria for qualifying personnel through this method were set and evaluated. In total, 25 GMP-qualified cleanroom operators washed and disinfected their hands with UV dye hand wash lotion and UV dye hand alcohol, respectively. To obtain a proof-of-concept, the results were judged based on adherence to the WHO six-step protocol and associated acceptance criteria. Commonly missed areas were brought to light, and the influence of procedure duration was investigated. UV-dye-based assessments appeared to be more valuable in hand disinfection than in hand washing. In both procedures, the back of the hands and the thumbs were frequently missed. This underpins the need for enhanced and repeated education on hand washing and disinfection. Additionally, a dry skin gave rise to extra cleaning challenges. From this pharmacy practice pilot study with a focus on pharmaceutical product care, it may be concluded that the application of UV-dye-based assessments offers valuable insights for pharmacists to optimize hand hygiene, thereby increasing the safety of tailor-made medicines and on-site preparations. Full article
(This article belongs to the Section Pharmacy Practice and Practice-Based Research)
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14 pages, 1618 KiB  
Article
Mucoadhesive Budesonide Solution for the Treatment of Pediatric Eosinophilic Esophagitis
by Antonio Spennacchio, Antonio Lopalco, Giuseppe Francesco Racaniello, Annalisa Cutrignelli, Flavia Maria la Forgia, Sergio Fontana, Fernanda Cristofori, Ruggiero Francavilla, Angela Assunta Lopedota and Nunzio Denora
Pharmaceuticals 2024, 17(5), 550; https://doi.org/10.3390/ph17050550 - 24 Apr 2024
Cited by 3 | Viewed by 3008
Abstract
Eosinophilic Esophagitis is an antigen-mediated inflammatory disease characterized by thickening of the esophageal wall, leading to dysphagia, vomiting, reflux, and abdominal pain. This disease can be treated with a therapeutic approach ranging from diet to pharmacological therapy. Jorveza® (budesonide) and Dupixent® [...] Read more.
Eosinophilic Esophagitis is an antigen-mediated inflammatory disease characterized by thickening of the esophageal wall, leading to dysphagia, vomiting, reflux, and abdominal pain. This disease can be treated with a therapeutic approach ranging from diet to pharmacological therapy. Jorveza® (budesonide) and Dupixent® (dupilumab) are treatments for Eosinophilic Esophagitis approved by the European Medicines Agency in adults but not in children. Budesonide-based extemporaneous oral liquid suspensions could be prepared for pediatric use. The main limit of this formulation is that budesonide needs a longer residence time on the esophageal mucosa to solubilize and diffuse in it to exert its local anti-inflammatory effect. Herein, we propose the development of an extemporaneous mucoadhesive oral budesonide solution for the pediatric population. A liquid vehicle containing hydroxypropyl-beta-cyclodextrin as a complexing agent and carboxymethylcellulose sodium as a mucoadhesive excipient was used to prepare budesonide-based formulations. A stable solution at a concentration of 0.7 mg/mL was successfully prepared and characterized. The formulation showed rheological and mucoadhesive properties suitable for an Eosinophilic Esophagitis local prolonged treatment. In this way, pharmacists can prepare stable budesonide-based mucoadhesive solutions, providing both patients and physicians with a new therapeutic option for Eosinophilic Esophagitis pediatric treatment. Full article
(This article belongs to the Special Issue Development of Medicines for Rare Pediatric Diseases II)
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10 pages, 912 KiB  
Article
Application of Accelerated Predictive Stability Studies in Extemporaneously Compounded Formulations of Chlorhexidine to Assess the Shelf Life
by Olga González-González, M. Paloma Ballesteros, Juan J. Torrado and Dolores R. Serrano
Molecules 2023, 28(23), 7925; https://doi.org/10.3390/molecules28237925 - 4 Dec 2023
Cited by 3 | Viewed by 3875
Abstract
Industrially fabricated medicines have a well-defined shelf life supported by rigorous studies before their approval for commercialization. However, the shelf life of extemporaneous compounding topical formulations prepared at hospitals tends to be shorter, especially when no data are available to prove a longer [...] Read more.
Industrially fabricated medicines have a well-defined shelf life supported by rigorous studies before their approval for commercialization. However, the shelf life of extemporaneous compounding topical formulations prepared at hospitals tends to be shorter, especially when no data are available to prove a longer stability period. Also, the storage conditions are unknown in many circumstances. Accelerated Predictive Stability (APS) studies have been shown to be a useful tool to predict in a faster and more accurate manner the chemical stability of extemporaneously compounded formulations requiring a minimum amount of formulation, thereby reducing the chemical drug waste per study. Shelf life will be allocated based on scientific data without compromising drug efficacy or safety. In this work, the APS approach was applied to the commercially available Cristalmina® (CR) and an extemporaneously compounded formulation of chlorhexidine (DCHX). A different degradation kinetic was found between DCHX and CR (Avrami vs. zero-order kinetics, respectively). This can explain the different shelf life described by the International Council for Harmonisation of Technical Requirements Registration Pharmaceuticals Human Use (ICH) conditions between both formulations. A predicted stability for the DCHX solution was obtained from the extrapolation of the degradation rate in long-term conditions from the Arrhenius equation. The estimated degradation from the Arrhenius equation for DCHX at 5 °C, 25 °C, and 30 °C at 365 days was 3.1%, 17.4%, and 25.9%, respectively. The predicted shelf life, in which the DCHX content was above 90%, was 26.67 months under refrigerated conditions and 5.75 and 2.24 months at 25 and 30 °C, respectively. Currently, the Spanish National Formulary recommends a shelf life of no longer than 3 months at room temperature for DCHX solution. Based on the predicted APS and confirmed by experimental long-term studies, we have demonstrated that the shelf life of DCHX extemporaneously compounded formulations could be prolonged by up to 6 months. Full article
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