Perbandingan Povidone-Iodine Versus Savlon Untuk Pembersihan Pra-Kateterisasi Dan
23805 Role of Povidone Poster VIS v2 - Diomed … role of povidone poster.pdf · The role of the...
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Please turn over for poster summary. This poster was presented at the 23 rd EADV Congress in October 2014, Amsterdam, The Netherlands. The role of the excipient povidone in an advanced gel formulation specially designed for the treatment of dry skin conditions J.Gallagher 1 , P. Rosher 1 , D. Mohammed 1 , G. Oliveira 1 , M. Lane 2 1 Dermal Laboratories Ltd, Hitchin, UK 2 School of Pharmacy, UCL, London, UK 0 10 20 30 40 % Weight Loss 50.0 30.0 Target Relative Humidity (%) Figure 1. DVS data measuring evaporative loss over 3 hours at three relative humidities 10.0 50 60 70 DELP DELP NO PVP DIPC Figure 2. Cryo-SEM images of DELP and DELP with no PVP DELP gel Figure 3. Cryo-SEM images of DELP and DIPC DELP gel with no PVP DELP gel DIPC cream Results and Discussion Significant differences (p<0.05) in weight loss over time were observed between the DELP gels with and without PVP (Figure 1). At all three RHs, the PVP-containing gel lost less weight compared with the identical gel without PVP. This weight loss is most likely formulation water, and the differences cannot be accounted for by the slightly higher water content of DELP without PVP. This indicates that the PVP helps to bind water into the structural matrix. In addition, both gels lost significantly less weight compared with the DIPC emollient cream. The cryo-SEM images suggested microstructural differences between DELP gel with and without PVP (Figure 2). Carbopol gels have been reported to form “honeycombed” polymeric structures when observed under cryo-SEM 1 , which is evident here. The spherical structures are most likely oil droplets dispersed within the gel structure and stabilised by the polymer network. With the PVP, the polymeric network appears to be tighter and the oil droplets are smaller. The tighter polymer network observed in the PVP- containing formulation may explain the reduced weight loss in Figure 1 – owing to evaporating formulation water having to diffuse through a more resistant/tighter microstructural matrix. Mag 8000x Mag 10000x The cryo-SEM images obtained for the DIPC cream formulation show a relatively dense network of ‘lamellar’ microstructures (Figure 3). In contrast to DELP formulations, the oily phase in this oil in water cream is not clearly distinguished. In a previous clinical study comparing DELP (with PVP) and DIPC applied twice daily, DELP achieved significantly longer-lasting and better cumulative skin hydration and was generally preferred by subjects 2 . The observed structural differences between these two products, and the propensity for DELP gel to hold onto formulation water, may be contributing factors to the superior in vivo performance of DELP gel. Conclusion The results of this study show that PVP significantly improves the water holding capacity of DELP, possibly by changing the gel’s microstructure. This may help explain DELP’s substantial, and long lasting, emolliency observed in vivo. 1 Kim J.Y., Song J.Y., Lee, E.J. and Park S.K. (2003). “Rheological properties and microstructures of carbopol gel network system” Colloid & Polymer Science 281(7): 614-623 2 Gallagher J., Rosher P., Walker J. and Hart V.A. (2012). “An in vivo comparison of two commercially available topical emollients in the UK, DELP gel and DIPC cream “ presented at the 70 th Annual Meeting of the American Academy of Dermatology, San Diego, USA. Doublebase Dayleve and Diprobase are Trade Marks Emollient Doublebase Dayleve™ Gel (DELP) comprising a high level of oils and the humectant glycerol, plus the film-forming agent povidone (PVP), is commonly prescribed in the UK for the treatment of dry skin conditions, such as eczema and psoriasis, when substantial and long-lasting emolliency is needed. The aim of this study was to investigate the role of PVP in this formulation by comparing the evaporative retention and microstructure of DELP with and without PVP. An alternative emollient cream, Diprobase Cream™ (DIPC), was included as a comparator. Introduction Materials & Methods Gravimetric investigation • Dynamic Vapour Sorption (DVS) was used to measure mass changes (evaporative loss) of the formulations over 3h at three relative humidities (RH) of 50%, 30% and 10% and a fixed temperature of 32°C ± 0.5°C. • Three replicates comprising standardised amounts were used for each formulation. • Data were collected and analysed using DVS software (v 3.01 Surface Measurements Systems). Statistical analysis was performed using t-Test to compare the means. Microstructural investigation • The microstructural properties of the formulations were observed using cryo- Scanning Electron Microscopy (SEM), using a FEI Quanta 200 F microscope, operated under routine SEM conditions (ultra-high vacuum; Field Emission), and augmented with a PP3000T cryo preparation chamber by Quorum Technologies. • The formulations were mounted on a brass specimen holder and plunge frozen in liquid nitrogen slush. The frozen specimen was fractured inside the cryo preparation chamber with a remotely controlled blade, followed by partial sublimation to remove all the water from the samples (8 and 10 min at -95°C and -100°C) and surface sputtering with platinum (5-10 mA for 30 seconds). Acknowledgment • Cryo-SEM sample preparation and imaging were performed by Mr David McCarthy, Experimental Officer at the Electron Microscopy Unit, School of Pharmacy, UCL, UK.
Transcript of 23805 Role of Povidone Poster VIS v2 - Diomed … role of povidone poster.pdf · The role of the...
Please turn over for poster summary.
This poster was presented at the 23rd EADV Congress in October 2014, Amsterdam, The Netherlands.
The role of the excipient povidone in an advanced gel formulation speciallydesigned for the treatment of dry skin conditions
J.Gallagher1, P. Rosher1, D. Mohammed1, G. Oliveira1, M. Lane2
1Dermal Laboratories Ltd, Hitchin, UK2School of Pharmacy, UCL, London, UK
0
10
20
30
40
% W
eig
ht L
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% W
eig
ht L
oss
50.0 30.0Target Relative Humidity (%)
Figure 1. DVS data measuring evaporative loss over 3 hours at three relative humidities
10.0
50
60
70 DELP DELP NO PVP DIPC
0
10
20
30
40
50.0 30.0Target Relative Humidity (%)
Figure 1. DVS data measuring evaporative loss over 3 hours at three relative humidities
10.0
50
60
70 DELP DELP NO PVP DIPC
Figure 2. Cryo-SEM images of DELP and DELP with no PVP
DELP gel
Figure 3. Cryo-SEM images of DELP and DIPC
DELP gel with no PVPDELP gel
DIPC cream
Results and DiscussionSignifi cant differences (p<0.05) in weight loss over time were observed between the DELP gels with and without PVP (Figure 1). At all three RHs, the PVP-containing gel lost less weight compared with the identical gel without PVP. This weight loss is most likely formulation water, and the differences cannot be accounted for by the slightly higher water content of DELP without PVP. This indicates that the PVP helps to bind water into the structural matrix. In addition, both gels lost signifi cantly less weight compared with the DIPC emollient cream.
The cryo-SEM images suggested microstructural differences between DELP gel with and without PVP(Figure 2). Carbopol gels have been reported to form “honeycombed” polymeric structures when observed under cryo-SEM1, which is evident here. The spherical structures are most likely oil droplets dispersedwithin the gel structure and stabilised by the polymer network. With the PVP, the polymeric networkappears to be tighter and the oil droplets are smaller. The tighter polymer network observed in the PVP-containing formulation may explain the reduced weight loss in Figure 1 – owing to evaporating formulation water having to diffuse through a more resistant/tighter microstructural matrix.
Mag 8000x
Mag 10000x
The cryo-SEM images obtained for the DIPC cream formulation show a relatively dense network of‘lamellar’ microstructures (Figure 3). In contrast to DELP formulations, the oily phase in this oil in watercream is not clearly distinguished.
In a previous clinical study comparing DELP (with PVP) and DIPC applied twice daily, DELP achieved signifi cantly longer-lasting and better cumulative skin hydration and was generally preferred by subjects2. The observed structural differences between these two products, and the propensity for DELP gel to hold onto formulation water, may be contributing factors to the superior in vivo performance of DELP gel.
ConclusionThe results of this study show that PVP signifi cantly improves the water holding capacity of DELP, possibly by changing the gel’s microstructure. This may help explain DELP’s substantial, and long lasting, emolliency observed in vivo.
1Kim J.Y., Song J.Y., Lee, E.J. and Park S.K. (2003). “Rheological properties and microstructures of carbopol gel network system” Colloid & Polymer Science 281(7): 614-6232Gallagher J., Rosher P., Walker J. and Hart V.A. (2012). “An in vivo comparison of two commercially available topical emollients in the UK, DELP gel and DIPC cream “ presented at the 70th Annual Meeting of the American Academy of Dermatology, San Diego, USA. Doublebase Dayleve and Diprobase are Trade Marks
Emollient Doublebase Dayleve™ Gel (DELP) comprising a high level of oils and the humectant glycerol, plus the fi lm-forming agent povidone (PVP), is commonly prescribed in the UK for the treatment of dry skin conditions, such as eczema and psoriasis, when substantial and long-lasting emolliency is needed.
The aim of this study was to investigate the role of PVP in this formulation by comparing the evaporative retention and microstructure of DELP with and without PVP. An alternative emollient cream, Diprobase Cream™ (DIPC), was included as a comparator.
Introduction
Materials & Methods
Gravimetric investigation • Dynamic Vapour Sorption (DVS) was
used to measure mass changes (evaporative loss) of the formulationsover 3h at three relative humidities (RH) of 50%, 30% and 10% and a fi xed temperature of 32°C ± 0.5°C.
• Three replicates comprising standardised amounts were used for eachformulation.
• Data were collected and analysed using DVS software (v 3.01 Surface Measurements Systems). Statistical analysis was performed using t-Test to compare the means.
Microstructural investigation• The microstructural properties of the
formulations were observed using cryo- Scanning Electron Microscopy (SEM), using a FEI Quanta 200 F microscope, operated under routine SEM conditions (ultra-high vacuum; Field Emission), and augmented with a PP3000T cryo preparation chamber by Quorum Technologies.
• The formulations were mounted on a brass specimen holder and plunge frozen in liquid nitrogen slush. The frozen specimen was fractured inside the cryo preparation chamber with a remotely controlled blade, followed by partial sublimation to remove all the water from the samples (8 and 10 min at -95°C and -100°C) and surface sputtering with platinum (5-10 mA for 30 seconds).
Acknowledgment• Cryo-SEM sample preparation and
imaging were performed by Mr David McCarthy, Experimental Offi cer at the Electron Microscopy Unit, School of Pharmacy, UCL, UK.
23805_Role of Povidone Poster_VIS v2.indd 1 15/10/2014 11:05
The role of the excipient povidone in Doublebase Dayleve Gel – an enhanced gel formulation
Doublebase Dayleve Gel contains a high level of emollient oils and the humectant glycerol, plus the film-forming agent povidone (PVP). It is commonly prescribed in the UK for the treatment of dry skin conditions when long lasting protection is needed and the convenience of as little as twice daily application.
This study aimed to investigate the role of PVP in this formulation by comparing the evaporative retention and microstructure of Doublebase Dayleve Gel with and without PVP, with a comparator emollient cream.
The study summarised overleaf shows that PVP significantly improves the water holding capacity of Doublebase Dayleve Gel, which supports the substantial and long lasting emolliency observed in vivo.
Summary of Poster Overleaf:
• Dynamic Vapour Sorption (DVS) was used to measure mass changes (evaporative loss) of the formulations over 3h at three relative humidities (RH) of 50%, 30% and 10% and at a fixed temperature 32°C ± 0.5°C.
• Doublebase Dayleve Gel (with PVP) lost significantly (p<0.05) less weight compared with the identical gel without PVP at all three RHs. Both gels lost significantly less weight compared with the comparator emollient cream. This weight loss is most likely formulation water.
• Microstructural properties of the formulations were observed using cryo-Scanning Electron Microscopy (SEM). Under SEM the gel matrix can be seen as a “honeycombed” polymeric structure with evenly dispersed small oil droplets. The addition of PVP in the formulation appears to enhance the carbomer gel matrix to give a ‘tighter’ structure with smaller oil droplets.
• In contrast, the structure of the emollient cream is very different with no clearly distinguished oily phase.
Conclusion:
“The results of this study show that PVP significantly improves the water holding capacity of DELP, possibly by changing the gel’s microstructure. This may help explain DELP’s substantial, and long lasting, emolliency observed in vivo.”
PreSCribinG infOrmaTiOn.
Doublebase Dayleve™ Gelisopropyl myristate 15% w/w, liquid paraffin 15% w/w.Uses: Long lasting, highly moisturising and protective hydrating gel for dry skin conditions.
Directions: Adults, children and the elderly: Apply direct to dry skin morning and night, or as often as necessary.
Contra-indications, warnings, side-effects etc: Please refer to SPC for full details before prescribing. Do not use if sensitive to any of the ingredients. In the rare event of a reaction stop treatment.
Package quantities, nHS prices and ma number: 100g tube £2.65, 500g pump dispenser £6.29, PL00173/0199.
Legal category: P
ma holder: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR.
Date of preparation: December 2013.
‘Doublebase’ and ‘Dayleve’ are trademarks.
700851 DXX351/OCT14
adverse events should be reported. reporting forms and information can be found at www.mhra.gov.uk/yellowcard. adverse events should also be reported to Dermal.
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