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Betamethasone dipropionate compounding for cutaneous T-cell lymphoma management
  1. Patrícia Trindade1,
  2. Alice Gelpi2,
  3. Ana Salgado1,
  4. Joana Marto1,
  5. Paula Machado3,
  6. Dinis Mateus1,
  7. Humberto Gonçalves1,
  8. M Fernanda Sachse4,
  9. António Melo Gouveia1,
  10. Helena Ribeiro2
  1. 1Department of Pharmacy, Instituto Português de Oncologia de Lisboa Francisco Gentil EPE, Lisbon, Portugal
  2. 2Department of Nanomedicine and Drug Delivery Systems, iMed.UL (Research Institute for Medicines and Pharmaceutical Sciences) Faculdadec de Farmácia da Universidade de Lisboa, Lisbon, Portugal
  3. 3ADEIM, Faculdade de Farmácia da Universidade de Lisboa, Lisbon, Portugal
  4. 4Dermatology Service, Instituto Português de Oncologia de Lisboa Francisco Gentil EPE, Lisbon, Portugal
  1. Correspondence to Helena Ribeiro, Department of Nanomedicine and Drug Delivery Systems, iMed.UL (Research Institute for Medicines and Pharmaceutical Sciences) Faculdadec de Farmácia da Universidade de Lisboa, Av. Prof. Gama Pinto, Lisboa 1649-003, Portugal; hribeiro{at}campus.ul.pt

Abstract

Background Primary cutaneous lymphomas (extranodular non-Hodgkin lymphomas) are rare (incidence 1:100 000). Mycosis fungoides is the most common cutaneous T-cell lymphoma (CTCL) subtype. Treatment options are based on the diagnosis and the stage of the disease. Skin-directed therapies are useful for the initial stages and include topical treatments such as corticosteroids. Betamethasone dipropionate (BD) is a synthetic glucocorticoid with high anti-inflammatory activity, potency and immunosuppressant effects. It is used for topical treatment of CTCL within the following dosage 0.025–0.1% (w/w). In the Portuguese market only one topical cream contains BD at 0.05% (w/w).

Objectives To develop a new and stable emulsion containing 0.1% of BD.

Methods To accomplish this aim, development, stability, in vitro release and clinical studies of a new topical water-in-oil emulsion containing BD 0.1% w/w were assessed for the topical treatment of CTCL.

Results The three batches prepared were physically, chemically and microbiologically stable over a period of 90 days. 40% of BD was released over 6 hours and evaluation of skin lesions showed a favourable clinical effect (less itching, less infiltration, fewer patches and a reduced area of plaque).

Conclusions The clinical results show the effective cutaneous improvement of skin barrier conditions during the study.

  • compounding topical emulsions,
  • betamethasone dipropionate
  • Cutaneous T-cells lymphomas
  • clinical studies
  • in vitro release
  • stability

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