Design and development of topical liposomal formulations in a regulatory perspective

Schlich, Michele; Musazzi, Umberto M.; Campani, Virginia; Franzè, Silvia; Lai, Francesco; Rosa, Giuseppe De; Sinico, Chiara

doi:10.1007/s13346-021-01089-z

Cited by 12 publications

(9 citation statements)

References 137 publications

(129 reference statements)

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“…One of the reasons for the small number of nanoformulations on the market is the lack of robust in vitro studies with confirmed in vitro/in vivo correlations that can be used instead of clinical studies [ 169 ]. Currently, the risk/benefit ratio of the topical nanoformulations is evaluated on a case-by-case basis because of the lack of harmonized quality standards and regulatory frameworks [ 169 ]. Since clinical trials are not required for cosmetics, there is also a lack of evidence to support the claimed efficacy of cosmetic nanoformulations.…”

Section: Discussionmentioning

confidence: 99%

Use of Retinoids in Topical Antiaging Treatments: A Focused Review of Clinical Evidence for Conventional and Nanoformulations

Milosheska¹,

Roškar

2022

Adv Ther

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Nowadays, numerous skincare routines are used to rejuvenate aging skin. Retinoids are one of the most popular ingredients used in antiaging treatments. Among the representatives of retinoids, tretinoin is considered the most effective agent with proven antiaging effects on the skin and can be found in formulations approved as medicines for topical treatment of acne, facial wrinkles, and hyperpigmentation. Other retinoids present in topical medicines are used for various indications, but only tazarotene is also approved as adjunctive agent for treatment of facial fine wrinkling and pigmentation. The most commonly used retinoids such as retinol, retinaldehyde, and retinyl palmitate are contained in cosmeceuticals regulated as cosmetics. Since clinical efficacy studies are not required for marketing cosmetic formulations, there are concerns about the efficacy of these retinoids.

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Section: Discussionmentioning

confidence: 99%

Use of Retinoids in Topical Antiaging Treatments: A Focused Review of Clinical Evidence for Conventional and Nanoformulations

Milosheska¹,

Roškar

2022

Adv Ther

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“…[ 7,8 ] For the aforementioned class of nanomedicines, references are available in the literature to further deepen the discussion of critical quality attributes and other regulatory requirements for assessing quality, efficacy, and safety profiles. [ 3,34 ]…”

Section: Regulatory Qualification Of Nanomedicine Productsmentioning

confidence: 99%

“…[30,31] The proper classification of nanomedicine products affects the development toward marketing authorization of a first-inhuman product, the management of its postmarketing modifications as well as the development of therapeutically equivalent copies at the time of patent expiration of the reference nanomedicine. [32][33][34] Indeed, due to the inherent complexity, the equivalence of NBCDs and nanomedicine products cannot be assessed, as it occurs for generics, based on pharmaceutical equivalence and bioequivalence. [3,5] On the one hand, there is still the need to expand the arsenal of validated methodologies for the characterization of nanomedicines.…”

Section: Nonbiological Complex Drugsmentioning

confidence: 99%

Feeding Next‐Generation Nanomedicines to Europe: Regulatory and Quality Challenges

Musazzi,

Franzè,

Condorelli

et al. 2023

Adv Healthcare Materials

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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.

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“…Liposomes are generally spherical vesicles containing single or multiple phospholipid bilayers and an aqueous core. Conventional liposomes tend to be rigid and unyielding, rendering it hard for them to penetrate the SC as whole [ 134 ]. The encapsulated therapeutics are mostly deposited in superficial skin layers, being released via the exchange of the lipid component between liposomes and the SC.…”

Section: Novel Pharmaceutical Strategies For Skin Penetrationmentioning

confidence: 99%

Novel Pharmaceutical Strategies for Enhancing Skin Penetration of Biomacromolecules

et al. 2022

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Skin delivery of biomacromolecules holds great advantages in the systemic and local treatment of multiple diseases. However, the densely packed stratum corneum and the tight junctions between keratinocytes stand as formidable skin barriers against the penetration of most drug molecules. The large molecular weight, high hydrophilicity, and lability nature of biomacromolecules pose further challenges to their skin penetration. Recently, novel penetration enhancers, nano vesicles, and microneedles have emerged as efficient strategies to deliver biomacromolecules deep into the skin to exert their therapeutic action. This paper reviews the potential application and mechanisms of novel skin delivery strategies with emphasis on the pharmaceutical formulations.

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Design and development of topical liposomal formulations in a regulatory perspective

Cited by 12 publications

References 137 publications

Use of Retinoids in Topical Antiaging Treatments: A Focused Review of Clinical Evidence for Conventional and Nanoformulations

Use of Retinoids in Topical Antiaging Treatments: A Focused Review of Clinical Evidence for Conventional and Nanoformulations

Feeding Next‐Generation Nanomedicines to Europe: Regulatory and Quality Challenges

Novel Pharmaceutical Strategies for Enhancing Skin Penetration of Biomacromolecules

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