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Article ; Online: Marketing authorisations for unmet medical needs: A critical appraisal of regulatory pathways in the European Union.

Manellari, Sara / Musazzi, Umberto M / Rocco, Paolo / Minghetti, Paola

2023 Volume 642, Page(s) 123193

Abstract: For unmet medical needs, the European Union has established fast-track regulatory pathways for ensuring patients' access to essential treatments. It is the case of the Conditional Marketing Authorisation (CMA) and the Authorisation under "Exceptional ... ...

Abstract	For unmet medical needs, the European Union has established fast-track regulatory pathways for ensuring patients' access to essential treatments. It is the case of the Conditional Marketing Authorisation (CMA) and the Authorisation under "Exceptional Circumstances" (EXC), which can be granted even if the clinical part of a medicinal product's dossier is not yet complete. The article aims to discuss the peculiarity of such regulatory pathways and assess the impact of their application on products' market access and penetration. A review of the regulatory history of medicines authorised with EXC or CMA has been performed on European Institutional databases (e.g., EMA portal, Union Register). Excluding vaccines, 71 CMAs and 51 EXCs were granted in the EU from 2002 and 2006, respectively, to 2022. Most CMAs have been released for the treatment of different types of tumours, while most of EXCs for alimentary tract and metabolism diseases, especially in the paediatric population, addressing unmet medical needs. Therefore, both regulatory pathways are effective for placing on the market essential medicines, preserving the initial positive benefit-risk balance. However, on average, CMAs are converted into "normal" authorisations only after a time which is significantly longer than the provided one-year renewal period, suggesting that such a regulatory pathway is still far from optimized.
MeSH term(s)	Child ; Humans ; European Union ; Drug Approval ; Neoplasms ; Marketing ; Risk Assessment
Language	English
Publishing date	2023-06-30
Publishing country	Netherlands
Document type	Review ; Journal Article
ZDB-ID	428962-6
ISSN	1873-3476 ; 0378-5173
ISSN (online)	1873-3476
ISSN	0378-5173
DOI	10.1016/j.ijpharm.2023.123193
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Article: Considerations on D-mannose Mechanism of Action and Consequent Classification of Marketed Healthcare Products.

Scaglione, Francesco / Musazzi, Umberto M / Minghetti, Paola

Frontiers in pharmacology

2021 Volume 12, Page(s) 636377

Abstract: Urinary tract infections (UTIs) are very common disorders that affect adult women. Indeed, 50% of all women suffer from UTIs at least one time in their lifetime; 20-40% of them experience recurrent episodes. The majority of UTIs seems to be due to ... ...

Abstract	Urinary tract infections (UTIs) are very common disorders that affect adult women. Indeed, 50% of all women suffer from UTIs at least one time in their lifetime; 20-40% of them experience recurrent episodes. The majority of UTIs seems to be due to uropathogenic
Language	English
Publishing date	2021-03-02
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2021.636377
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Article ; Online: Equivalence assessment of creams with quali-quantitative differences in light of the EMA and FDA regulatory framework.

Volontè, Paola / Musazzi, Umberto M / Arnaboldi, Luca / Ortenzi, Marco A / Casiraghi, Antonella / Cilurzo, Francesco / Minghetti, Paola

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

2024 Volume 195, Page(s) 106726

Abstract: EMA and FDA are upgrading guidelines on assessing the quality and the equivalence of topically applied drug products for developing copies of originator products and supporting post-marketing variations. For topical products having remarkably similar ... ...

Abstract	EMA and FDA are upgrading guidelines on assessing the quality and the equivalence of topically applied drug products for developing copies of originator products and supporting post-marketing variations. For topical products having remarkably similar composition, both EMA and FDA accept the equivalence on the bases of the comparison of rheological properties and in vitro drug release constant (k) and skin permeation flux (J) values, instead of clinical studies. This work aims to evaluate the feasibility to expand this approach to variations of the composition of complex semi-solid preparations. Ibuprofen (IB) creams at two different strengths (i.e., 1 % and 10 %) were used as a model formulation. Two formulative changes were performed: (a) the addition of the humectant to simulate a minor post-marketing variation; (b) the substitution of the emulsifying system to simulate a major one. These variations impacted only in 1 % IB formulations where both the equivalences of rheological data and J-values failed. At the highest concentration, the presence of IB crystals broke down the differences in rheological patterns and lead the IB thermodynamic activity at the maximum figuring out an overlapping of the J-values. Such data suggest the combination of these studies, which are thought mainly for the development of copies, could be also applied to the management of post-marketing variations that involve product composition.
MeSH term(s)	Skin/metabolism ; Skin Absorption ; Ibuprofen/metabolism ; Thermodynamics ; Rheology
Chemical Substances	Ibuprofen (WK2XYI10QM)
Language	English
Publishing date	2024-02-12
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1154366-8
ISSN	1879-0720 ; 0928-0987
ISSN (online)	1879-0720
ISSN	0928-0987
DOI	10.1016/j.ejps.2024.106726
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Zs.A 3705: Show issues

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Article ; Online: Feeding Next-Generation Nanomedicines to Europe: Regulatory and Quality Challenges.

Musazzi, Umberto M / Franzè, Silvia / Condorelli, Fabrizio / Minghetti, Paola / Caliceti, Paolo

Advanced healthcare materials

2023 Volume 12, Issue 30, Page(s) e2301956

Abstract: New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" ... ...

Abstract	New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.
MeSH term(s)	Humans ; Nanomedicine ; Artificial Intelligence ; Nanotechnology ; Europe
Language	English
Publishing date	2023-09-17
Publishing country	Germany
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2649576-4
ISSN	2192-2659 ; 2192-2640
ISSN (online)	2192-2659
ISSN	2192-2640
DOI	10.1002/adhm.202301956
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Zs.A 6966: Show issues

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Article ; Online: New regulatory strategies to manage medicines shortages in Europe.

Musazzi, Umberto M / Di Giorgio, Domenico / Minghetti, Paola

International journal of pharmaceutics

2020 Volume 579, Page(s) 119171

Abstract: Medicine shortages have been spreading in European countries. In many cases, the unavailability of medicinal products has a substantial impact on the capability of National Healthcare Systems in ensuring the continuity of care. Shortages originate from ... ...

Abstract	Medicine shortages have been spreading in European countries. In many cases, the unavailability of medicinal products has a substantial impact on the capability of National Healthcare Systems in ensuring the continuity of care. Shortages originate from multifactorial causes. In particular, they can be due to supply-related factors (e.g., manufacturing issues, regulatory issues, logistics, distribution) and demand-related ones (e.g., fluctuating drug demand, parallel market, tendering, price and reimbursement policies). However, some extraordinary geopolitical events (e.g., Brexit) may also affect medicines' availability. The capability of European Regulatory Authorities and other stakeholders, which are involved in the pharmaceutical distribution chain and the healthcare assistance services, to define suitable problem-solving strategies has been limited for years by the fragmentation of the European regulatory framework, starting from the lack of a univocal definition of a medicine shortage. Only in 2019, the EMA and HMA joint task force released the first harmonized "shortage" definition in the European Economic Area (EEA) and guidance on public communication. This manuscript aims to review the current European regulatory framework on medicine shortages. To support the activities of regulators, manufacturers and other healthcare professionals, an algorithm was also proposed to be used as a harmonized procedure to determine the shortage/unavailability impact on public health and to rationalize the problem-solving strategies adopted in all different settings.
MeSH term(s)	Drug and Narcotic Control/legislation & jurisprudence ; European Union ; Humans ; Pharmaceutical Preparations/supply & distribution ; Problem Solving
Chemical Substances	Pharmaceutical Preparations
Keywords	covid19
Language	English
Publishing date	2020-02-21
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	428962-6
ISSN	1873-3476 ; 0378-5173
ISSN (online)	1873-3476
ISSN	0378-5173
DOI	10.1016/j.ijpharm.2020.119171
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Article: Liver injury and dietary supplements: Does hydroxycitric acid trigger hepatotoxicity?

Zovi, Andrea / Langella, Roberto / Nisic, Andrea / Vitiello, Antonio / Musazzi, Umberto M

Journal of integrative medicine

2022 Volume 20, Issue 5, Page(s) 473–475

Abstract: Rising rates of obesity has increased the global use of herbal supplements intended to control weight. However, taking these preparations without appropriate medical supervision could increase the risk of manifestation of side effects, especially at the ... ...

Abstract	Rising rates of obesity has increased the global use of herbal supplements intended to control weight. However, taking these preparations without appropriate medical supervision could increase the risk of manifestation of side effects, especially at the hepatic level. In literature, different cases of acute liver injury consequent to the use of food supplements containing Garcinia cambogia and hydroxycitric acid are reported. This letter aims to review the most recent literature that analysed the herb-induced liver disease due to the use of hydroxycitric acid, from the first alert coming from the European Food and Drug Administration in 2009, to the last recent European food alerts from 2020 to 2021. It is noteworthy that in some cases it demonstrated the relationship between hydroxycitric acid and hepatotoxicity. Therefore, there is a need to draw more attention to the relationship between a safe use and a more awareness in the intake of these supplements, to preserve the safety of the consumers who increasingly purchase food supplements, products that have only nutritive properties and are never curative.
MeSH term(s)	Anti-Obesity Agents/pharmacology ; Chemical and Drug Induced Liver Injury/drug therapy ; Chemical and Drug Induced Liver Injury/etiology ; Citrates ; Dietary Supplements/adverse effects ; Humans ; Plant Extracts/pharmacology
Chemical Substances	Anti-Obesity Agents ; Citrates ; Plant Extracts ; hydroxycitric acid (8W94T9026R)
Language	English
Publishing date	2022-05-30
Publishing country	Netherlands
Document type	Letter ; Review
ZDB-ID	2705612-0
ISSN	2095-4964
ISSN	2095-4964
DOI	10.1016/j.joim.2022.05.003
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Article ; Online: Old active ingredients in new medicinal products: is the regulatory path coherent with patients' expectations?

Minghetti, Paola / Musazzi, Umberto M / Casiraghi, Antonella / Rocco, Paolo

Drug discovery today

2020 Volume 25, Issue 8, Page(s) 1337–1347

Abstract: The rising costs of new medicinal products are a challenge to the economic sustainability of national healthcare systems in ensuring patients' access to therapies. European Union (EU) and US legislators have provided regulatory pathways aimed at ... ...

Abstract	The rising costs of new medicinal products are a challenge to the economic sustainability of national healthcare systems in ensuring patients' access to therapies. European Union (EU) and US legislators have provided regulatory pathways aimed at simplifying Marketing Authorization (MA) applications for new medicinal products in cases when safety and efficacy profiles can be derived from the data of already-marketed products. In this review, we discuss the different regulatory pathways towards the MA of new medicinal products containing old drug substances and intended to improve the therapeutic value of a treatment, to obtain a new therapeutic indication (drug repositioning), or to ensure the same therapeutic value of a reference product at lower costs.
MeSH term(s)	Drug Approval ; Drug Repositioning ; European Union ; Humans ; Marketing ; Motivation ; Therapeutic Equivalency
Language	English
Publishing date	2020-05-31
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1324988-5
ISSN	1878-5832 ; 1359-6446
ISSN (online)	1878-5832
ISSN	1359-6446
DOI	10.1016/j.drudis.2020.05.013
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Zs.A 4725: Show issues

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Article ; Online: Relevance of production method on the physical stability and in vitro biopharmaceutical performances of olanzapine orodispersible film.

Selmin, Francesca / Khalid, Garba M / Musazzi, Umberto M / Demartin, Francesco / Minghetti, Paola / Cilurzo, Francesco

International journal of pharmaceutics

2021 Volume 603, Page(s) 120697

Abstract: This study assessed the relevance of the preparation process, namely solvent casting and hot-melt ram printing, on the biopharmaceutical performances of olanzapine orodispersible films (ODF) made of maltodextrins. Beside the clinical rationale, ... ...

Abstract	This study assessed the relevance of the preparation process, namely solvent casting and hot-melt ram printing, on the biopharmaceutical performances of olanzapine orodispersible films (ODF) made of maltodextrins. Beside the clinical rationale, olanzapine was selected since it is subjected to polymorphism which impacts on its bioavailability. All ODF disintegrated in less than 3 min and showed content uniformity within the acceptable values. Dissolution testing in 3 mL of artificial saliva at pH = 6.8 evidenced that cast and printed ODF released after 5 min about 2% and 100%, respectively; at higher volume, a yellow precipitate was formed after disintegration of the cast ODF. At pH = 1.2, the t
MeSH term(s)	Administration, Oral ; Animals ; Biological Availability ; Biological Products ; Male ; Olanzapine ; Solubility ; Solvents
Chemical Substances	Biological Products ; Solvents ; Olanzapine (N7U69T4SZR)
Language	English
Publishing date	2021-05-11
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	428962-6
ISSN	1873-3476 ; 0378-5173
ISSN (online)	1873-3476
ISSN	0378-5173
DOI	10.1016/j.ijpharm.2021.120697
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Article ; Online: Extemporaneous printing of diclofenac orodispersible films for pediatrics.

Khalid, Garba M / Musazzi, Umberto M / Selmin, Francesca / Franzè, Silvia / Minghetti, Paola / Cilurzo, Francesco

Drug development and industrial pharmacy

2021 Volume 47, Issue 4, Page(s) 636–644

Abstract: Objective: The possible application of a hot-melt ram extrusion printing to the preparation of diclofenac orodispersible films (ODF) made of maltodextrin was studied focusing the attention on the effects of taste-masking agents (i.e. namely mint, ... ...

Abstract	Objective: The possible application of a hot-melt ram extrusion printing to the preparation of diclofenac orodispersible films (ODF) made of maltodextrin was studied focusing the attention on the effects of taste-masking agents (i.e. namely mint, licorice-mint, and sucralose) and an opacifier (titanium dioxide [TiO Significance: This is a proof-of-concept of the feasibility to print ODF loaded with a thermosensitive drug substance by hot-melt technologies. Methods: Diclofenac sodium (DNa) ODF made of maltodextrin (dextrose equivalent (DE) = 6 ) plasticized with glycerol were prepared by hot-melt extrusion printing. ODF were characterized for disintegration time, drug content, and solid state, Results: After the preparation, no variation in drug solid state was evident and the formation of impurity A of DNa was detected, even if it remained below the Pharmacopoeia (Ph. Eur.) limits (< 0.2%). Only the addition of DNa significantly improved the ODF tensile properties: the tensile strength increased from 0.17 ± 0.03 MPa (placebo ODF) to 2.21 ± 0.54 MPa ( Conclusion: Hot-melt printing can be suitable to prepare palatable ODF loaded with bitter thermosensitive drugs.
MeSH term(s)	Child ; Diclofenac ; Drug Compounding ; Humans ; Pediatrics ; Printing, Three-Dimensional ; Solubility ; Tensile Strength
Chemical Substances	Diclofenac (144O8QL0L1)
Language	English
Publishing date	2021-04-07
Publishing country	England
Document type	Journal Article
ZDB-ID	751874-2
ISSN	1520-5762 ; 0363-9045
ISSN (online)	1520-5762
ISSN	0363-9045
DOI	10.1080/03639045.2021.1908335
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Article ; Online: 3D printed mucoadhesive orodispersible films manufactured by direct powder extrusion for personalized clobetasol propionate based paediatric therapies.

Racaniello, Giuseppe Francesco / Pistone, Monica / Meazzini, Chiara / Lopedota, Angela / Arduino, Ilaria / Rizzi, Rosanna / Lopalco, Antonio / Musazzi, Umberto M / Cilurzo, Francesco / Denora, Nunzio

International journal of pharmaceutics

2023 Volume 643, Page(s) 123214

Abstract: The aim of this work is the development and production by Direct Powder Extrusion (DPE) 3D printing technique of novel oral mucoadhesive films delivering Clobetasol propionate (CBS), useful in paediatric treatment of Oral Lichen Planus (OLP), a rare ... ...

Abstract	The aim of this work is the development and production by Direct Powder Extrusion (DPE) 3D printing technique of novel oral mucoadhesive films delivering Clobetasol propionate (CBS), useful in paediatric treatment of Oral Lichen Planus (OLP), a rare chronic disease. The DPE 3D printing of these dosage forms can allow the reduction of frequency regimen, the therapy personalization, and reduction of oral cavity administration discomfort. To obtain suitable mucoadhesive films, different polymeric materials, namely hydroxypropylmethylcellulose or polyethylene oxide blended with chitosan (CS), were tested and hydroxypropyl-β-cyclodextrin was added to increase the CBS solubility. The formulations were tested in terms of mechanical, physico-chemical, and in vitro biopharmaceutical properties. The film showed a tenacious structure, with drug chemical-physical characteristics enhancement due to its partial amorphization during the printing stage and owing to cyclodextrins multicomponent complex formation. The presence of CS enhanced the mucoadhesive properties leading to a significant increase of drug exposure time on the mucosa. Finally, the printed films permeation and retention studies through porcine mucosae showed a marked retention of the drug inside the epithelium, avoiding drug systemic absorption. Therefore, DPE-printed films could represent a suitable technique for the preparation of mucoadhesive film potentially usable for paediatric therapy including OLP.
MeSH term(s)	Animals ; Swine ; Clobetasol ; Drug Delivery Systems/methods ; Powders ; Pharmaceutical Preparations ; Printing, Three-Dimensional ; Drug Liberation
Chemical Substances	Clobetasol (ADN79D536H) ; Powders ; Pharmaceutical Preparations
Language	English
Publishing date	2023-07-08
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	428962-6
ISSN	1873-3476 ; 0378-5173
ISSN (online)	1873-3476
ISSN	0378-5173
DOI	10.1016/j.ijpharm.2023.123214
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