Safety of Rectal LubricantsSafety of Rectal LubricantsSafety of Rectal Lubricants

David M Phillips PhDPopulation Council1230 York AveNew York, NY 10021

David M Phillips PhDPopulation Council1230 York AveNew York, NY 10021

MiceMiceMice• Can be infected by HSV-2

after vaginal or rectal challenge

• HSV-2 is a cofactor in HIV infection

• Visible symptoms of infection in 14 days

• Inexpensive• Easy to work with

• Can be infected by HSV-2 after vaginal or rectal challenge

• HSV-2 is a cofactor in HIV infection

• Visible symptoms of infection in 14 days

• Inexpensive• Easy to work with

Mouse Rectal ProtocolMouse Rectal ProtocolMouse Rectal Protocol

• Male mice• Withhold food 24 hours• Ketamine• 10 uL of test product• Wait 10 minutes• Inoculation of HSV-2• Observe for signs of infection (for

2 weeks)

• Male mice• Withhold food 24 hours• Ketamine• 10 uL of test product• Wait 10 minutes• Inoculation of HSV-2• Observe for signs of infection (for

2 weeks)

Comparison of FormulationsComparison of FormulationsComparison of Formulations

0 - 10% Infection Dose

0

10

20

30

40

50

60

70

80

90

100

PBS Gynol II KYPlus

Mic

e In

fect

ed (%

)

Human Rectal ProtocolHuman Rectal ProtocolHuman Rectal Protocol

• Baseline lavage• Insert product• Wait fifteen minutes• Rectal lavage

• Baseline lavage• Insert product• Wait fifteen minutes• Rectal lavage

ConclusionN-9 lubricants are not safe for rectal use

ConclusionConclusionNN--9 lubricants are not safe for rectal use9 lubricants are not safe for rectal use

QuestionWhat lubricants are or are not safe for

rectal use?

QuestionWhat lubricants are or are not safe for

rectal use?

AssaysAssaysAssays

• Cytotoxicity (in vitro)

• HSV-2 infection in mice

• Cell sloughing in mice

• Cytotoxicity (in vitro)

• HSV-2 infection in mice

• Cell sloughing in mice

Cytotoxicity (XTT Assay)Cytotoxicity (XTT Assay)Cytotoxicity (XTT Assay)

• Grow colorectal cells• Incubate with different

concentrations of test compound for 4 hours

• Measure number of live cells

• Grow colorectal cells• Incubate with different

concentrations of test compound for 4 hours

• Measure number of live cells

CytotoxicityCytotoxicityCytotoxicity

0

0.5

1

1.5

2

2.5

3

1% 2.5% 5% 10% 20%Control

% of Compound

Abs

orba

nce

(490

nm

)Carraguard Astroglide Control

CytotoxicityCytotoxicityCytotoxicity

1:330KY- Plus1:140Delube1:32Astroglide1:5Vagisil1:1Viamor

Non cytotoxic (1:1)CarraguardNon cytotoxic (1:1)Methylcellulose

Dilution (50% Cytotoxicity)Compounds

Rectal Mouse AssayRectal Mouse AssayRectal Mouse Assay

Rectal ProtectionRectal ProtectionRectal Protection

0

20

40

60

80

100

PBSCarr

agua

rdMeth

ylcell

ulose

Viamor

Vagisi

lAstr

oglid

e

Delube

KY Plus%

Mic

e Pr

otec

ted

Cell Sloughing in MiceCell Sloughing in MiceCell Sloughing in Mice

• Food withheld and ketamine• Insert product into rectum• Wait 15 min• Lavage rectum• Count sloughed cells

• Food withheld and ketamine• Insert product into rectum• Wait 15 min• Lavage rectum• Count sloughed cells

0.0E+00

1.0E+08

2.0E+08

3.0E+08

4.0E+08

5.0E+08

6.0E+08

7.0E+08

8.0E+08

9.0E+08

1.0E+09

PBS Methylcellulose Carraguard Vagisil Viamor Astroglide Delube KY-Plus

Num

ber o

f cel

ls/m

l

Epithelial Cells RecoveredEpithelial Cells RecoveredEpithelial Cells Recovered10

9

8

7

6

5

4

3

2

1

0

Num

ber

cells

/ml (

1 x

108 )

SummaryRanked in terms of Safety

SummarySummaryRanked in terms of SafetyRanked in terms of Safety

Compounds Cytotoxicity Rectal HSV-2 Enhancement

Rectal Sloughing

KY Plus ++++ ++++ ++++Delube ++++ ++++ ++++Astroglide ++ ++ ++Vagisil ++ ++ ++Viamor + ++ ++Carraguard - - -Methylcellulose - - -PBS - - -

ConclusionConclusionConclusion

• Using 3 assays: cytotoxicity, rectal challenge, and cell sloughing

• Lubricants for rectal use can be ranked in terms of rectal safety

• Hopefully this information will aid people in choosing a safe lubricant for rectal use

• Using 3 assays: cytotoxicity, rectal challenge, and cell sloughing

• Lubricants for rectal use can be ranked in terms of rectal safety

• Hopefully this information will aid people in choosing a safe lubricant for rectal use

Current WorkCurrent WorkCurrent Work• Currently assaying 13 additional sexual

lubricants• Next step – evaluating lubricants

commonly used in South and Central America

ThanksKristin Sudol

Robin Maguire

• Currently assaying 13 additional sexual lubricants

• Next step – evaluating lubricants commonly used in South and Central America

ThanksKristin Sudol

Robin Maguire