Poster presented at the 10th World Biomaterials Congress. Montreal, Canada, 17-22 May 2016N/

Bozukova, Dimitriya

Galante, Raquel

Oliveira, Andreia

Saramago, Benilde

Serro, A. P.

Topete, Ana

English

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Effect of sterilization on drugs and lenses for ophthalmic applications Ana Topete1, Andreia Oliveira1, Raquel Galante1,2,*, Dimitriya Bozukova3, Benilde Saramago1, A.P. Serro1,4 1Centro de Química Estrutural, Instituto Superior Técnico - Universidade de Lisboa, Lisboa, Portugal 2Departamento de Farmácia, Faculdade de Ciências Farmacêuticas - Universidade de São Paulo, São Paulo, Brasil 3PhysIOL, s.a., Science Park 4, Allée des Noisetiers,4031 , Liège, Belgium 4Centro De Investigação Interdisciplinar Egas Moniz, Instituto Superior de Ciências da Saúde Egas Moniz, Costa da Caparica, Portugal Steam and γ-radiation at 5 kGy seem to be promising methods for terminal sterilization of drugs and lenses. Next stage of this work is to study the drug release behavior before and after sterilization. [1] Terryn H, Maquille a, Houeelevin C, Tilquin B.. Int. J. Pharm. 2007;343(1-2):4-11.  [2] Maquille A, Jiwan JLH, Tilquin B.. Int. J. Pharm. 2008;349(1-2):74-82.  To Fundação para a Ciência e a Tecnologia for funding through projects UID/QUI/ 00100/2013 and M-ERA.NET/0005/2012 and to Eng. Paula Matos from CTN for the gamma irradiation. Sterilization conditions Steam Pressure  (60 min, 121oC and 1 bar) Gamma radiation (3 doses: 5, 15 and 25 kGy) DRUGS   Diclofenac • Aqueous solution     (NaCl 0.9%) • Powder • Aqueous solutions (NaCl 0.9%) • Aqueous solutions (NaCl 0.9%) + 5% mannitol Ketorolac Moxifloxacin Levofloxacin LENS   SCL Acuvue®Oasys® • Samples in aqueous solution (NaCl 0.9%) 1-Day Acuvue®TruEye® IOL Poly(meth)acrylic hydrogel Hydrophilic acrylate (26% water uptake)   The drugs sterilized with steam did not suffer degradation.    The γ-radiation led to different results depending on the form of presentation of the drugs:      Powders did not degrade at any dose;     Mannitol at 5% did not prevent the degradation of drugs as was suggested by the literature [1].   The γ-radiation doses of 15 kGy and 25 kGy degraded all drugs. So, these doses were abandoned.   At 5 kGy, the antibiotics did not present significant degradation in solution, while the anti-inflammatories suffered degradation at both doses, being diclofenac the most affected.  Steam sterilization did not affect significantly the materials transmittance.   γ-radiation sterilization led to a small decrease in transmittance of poly(meth)acrylic hydrogel. 1. Effect of sterilization on the drugs Figure 3. Swelling ratio at 36oC, before and after sterilization. *raquelgalante@usp.br 1st step Effect of sterilization on drugs Drug degradation (HPLC) 2nd step Effect of sterilization on lenses Transmittance (UV-Vis spectroscopy) Swelling ratio (36oC) Wettability (captive bubble method) Figure 4. Wettability before and after sterilization. Figure 2. Transmittance (UV-Vis spectroscopy) before and after sterilization. 2. Effect of sterilization on lenses Figure 1. Relative concentration of Diclofenac (A), Ketorolac (B), Moxifloxacin (C) and Levofloxacin (D), before and after sterilization, determined by HPLC.  Steam sterilization did not affect significantly the swelling behavior of the materials.   The γ-radiation sterilization enhanced the swelling behaviour of Acuvue®Oasys®. INTRODUCTION The most dramatic complication of intraocular lenses (IOLs) implantation is endophthalmitis, an infection caused by bacteria that may occur in the post-surgical period. The use of drug-loaded IOLs to prevent this problem has been regarded with great interest. Drug-loaded soft contact lenses (SCLs) also seem to constitute a promising vehicle for drug delivery that can be used in the treatment of a vast number of pathologies of the anterior part of the eye. However, these devices still do not exist in the market.  IOLs and SCLs sterilization is mandatory to fulfill strict microbiological safety requirements. However, the effects of sterilization procedures on drug-loaded hydrogels, including changes on the intrinsic properties of the materials, on the drug activity and drug release behavior, are mostly unknown.  This work aims to contribute for the clarification of the effects of different methods of sterilization on drugs and lenses for ophthalmic applications.  METHODS RESULTS CONCLUSIONS REFERENCES ACKNOWLEDGEMENTS 02550751005 15 25 5 15 25 5 15 25Nosteril.Steam kGyGR (Aqueoussolution)kGyGR (Aqueous solution with Mannitol)kGyGR (Powder)Relative concentration (%) Sterilization conditions Diclofenac 02550751005 15 25 5 15 25 5 15 25Nosteril.Steam kGyGR (Aqueoussolution)kGyGR (Aqueous solution with Mannitol)kGyGR (Powder)Relative concentration (%) Sterilization conditions Ketorolac 02550751005 15 25 5 15 25 5 15 25Nosteril.Steam kGyGR (Aqueoussolution)kGyGR (Aqueous solution with Mannitol)kGyGR (Powder)Relative concentration (%) Sterilization conditions Moxifloxacin 02550751005 15 25 5 15 25 5 15 25Nosteril.Steam kGyGR (Aqueoussolution)kGyGR (Aqueous solution with Mannitol)kGyGR (Powder)Relative concentration (%) Sterilization conditions Levofloxacin A B C D 020406080100Acuvue®Oasys® 1-DayAcuvue®TruEye®Poly(meth)acrylichydrogelHydrophilic acrylate(26% water uptake)%SR equlibrium No sterilization Steam sterilization 5 kGy GR0204060Acuvue®Oasys® 1-DayAcuvue®TruEye®Poly(meth)acrylichydrogelHydrophilicacrylate (26%water uptake)Contact angle (o) No sterilization Steam sterilization 5 kGy GR Steam sterilization slightly decreased the wettability of both commercial SCLs and  increased that of hydrophilic acrylate (26% water uptake).   γ-radiation sterilization decreased the wettability  of all materials with the exception  of  hydrophilic acrylate (26% water uptake), where a slight increase was observed. 020406080100380 480 580 680Transmittance (%) λ (nm) 020406080100380 480 580 680Transmittance (%) λ (nm) 020406080100380 480 580 680Transmittance (%) λ (nm) 020406080100380 480 580 680Transmittance (%) λ (nm) Acuvue®Oasys® 1-Day Acuvue®TruEye® Hydrophilic acrylate (26% water uptake) Poly(meth)acrylic hydrogel 2.1. Transmittance 2.2. Swelling 2.3. Wettability No sterilization Steam sterilization 5 kGy GR

Effect of sterilization on drugs and lenses for ophthalmic applications

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Effect of sterilization on drugs and lenses for ophthalmic applications

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