Excipients and solutions for RECTAL

Pharmaceuticals VAGINAL
Human and Veterinary applications ROUTES
(excluding Food producing animals)
May 02, 2012

Precedence
Pharmacopeias Market ref (1)
of use

DMF

Handbook
USP/NF

FDA IIG
Trade name Grades Definition

JP/JPE
Examples

EP
R V
(not exhaustive)

k
INTERESTERIFIED SUPPOSITORY BASES
SUPPOCIRE / JAPOCIRE STANDARD TYPE
Rectal references (worldwide),
SUPPOCIRE STANDARD A, AM, B, BM, CM, D, DM Hard Fat EP/NF/JPE/Ch. P. Q Q Q Q Q Q Q Q Vaginal references (worldwide)

SUPPOCIRE
S OC STANDARD
S Rectal references (worldwide),
AS2, BS2 Hard Fat EP/NF/JPE/Ch. P. Q Q Q Q Q Q Q Q
GRADE S2 Vaginal references (worldwide)

SUPPOCIRE STANDARD Hard Fat EP pending/NF/JPE Q Rectal references (worldwide),

AIML, AML, BML Q Q Q Q Q Q Q
GRADE L (with additive: Lecithins) pending Vaginal references (worldwide)

SUPPOCIRE STANDARD Hard Fat EP pending/NF/JPE/Ch. P. Q Rectal references (worldwide),

AS2X, BS2X, CS2X Q Q Q Q Q Q Q
GRADE S2X (with additive: Polysorbate 65) pending g
Vaginal references ((worldwide))

ESTERIFIED SUPPOSITORY BASES

SUPPOCIRE / JAPOCIRE N TYPE
NA, NA 0, NA 15, NAI 25, NAI Rectal references (worldwide),
SUPPOCIRE N Hard Fat EP/NF/JPE/Ch. P. Q Q Q Q Q Q Q Q
25 A, NAI 50, NB Vaginal references (worldwide)

NAS 40, NAS 50 Hard Fat EP/NF/JPE Q Q Q Q Q Q Q Rectal references (worldwide)

SUPPOCIRE N Q
NAS 55 Hard Fat EP pending/NF/JPE Q Q Q Q Q Q Rectal references (worldwide)
GRADE S pending

NAIS 10, NAIS 90 Hard Fat Q Q Q Q Rectal references (worldwide)

SUPPOCIRE N Hard Fat EP pending/NF/JPE Q

NAL, NBL Q Q Q Q Q Q Rectal references (worldwide)
GRADE L (with additive: Lecithins) pending

SUPPOCIRE N Hard Fat EP pending/NF/JPE Q

NCX Q Q Q Q Q Q Rectal references (worldwide)
GRADE X (with additive: Polysorbate 65) pending

AMPHIPHILIC SUPPOSITORY BASES

SUPPOCIRE P TYPE

SUPPOCIRE P AP, BP Saturated polyglycolysed glycerides Q Q Q Q Rectal references (worldwide)

The different grades of SUPPOCIRE and JAPOCIRE can have different regulatory status, please consult the document RDS (Regulatory data sheet), to have additional information
on the regulatory status of these products. 1
 Excipients and solutions for RECTAL
Pharmaceuticals VAGINAL
Human and Veterinary applications ROUTES
(excluding Food producing animals)
May 02, 2012

Precedence
P d
Pharmacopeias Market ref (1)
of use

DMF

Handbo
USP/N

FDA IIG
Trade name Definition Form

JP/JPE
Examples

EP
R V
((not exhaustive))

NF

ook
E

G
BASE FOR PESSARIES

Mixture of: Hard fat EP/NF/JPE

OVUCIRE WL 2944 Pellets Q Q Q Q Q /
( d) Gl
(and) Glyceroll monooleate
l t (T
(Type 40) EP/NF

Mixture of: Hard fat EP/NF/JPE (and) Ethoxylated

OVUCIRE WL 3264 Pellets Q Q Q Q Q /
fatty alcohols (Ceteth-20, Steareth-20) EP/NF

Mixture of: Hard fat EP/NF/JPE (and) Glyceryl

OVUCIRE 3460 ricinoleate (and) Ethoxylated fatty alcohols Pellets Q Q /
(Ceteth-20, Steareth-20) EP/NF
OTHER EXCIPIENTS FOR RECTAL AND VAGINAL APPLICATIONS (LIST NON EXHAUSTIVE FOR OTHER EXCIPIENTS, PLEASE REFER TO THE TOPICAL
ROUTE)
Oral ref (EU, USA, India, Asia),
Oleoyl macrogol-6 glycerides EP / Q Topical ref (EU, USA, India, Asia, RoW),
LABRAFIL M1944CS Liquid Q Q Q Q Q Q Vaginal/rectal ref (EU, USA, RoW), Nasal ref
Oleoyl polyoxyl-6 glycerides NF (O, T, etc)
(EU), Veto injectable (EU)

Linoleoyl macrogol-6 glycerides EP / Oral ref (worldwide), Topical ref (EU, USA,
Q
LABRAFIL M2125CS Liquid Q Q Q Q Q Q RoW), Vaginal/rectal ref (EU),
Linoleoyl polyoxyl-6 glycerides NF (O) Inhalation ref (EU)

Lauroyl macrogol
macrogol-66 glycerides EP / Semi-solid Q Vaginal/rectal ref (EU,
(EU USA
USA, India),
India)
LABRAFIL M2130CS Q Q Q Q Q Q
Lauroyl polyoxyl-6 glycerides NF in block (O, T, etc) Topical ref (EU, RoW)

Mixture of: PEG-6 stearate NF/JPE (and)

Semi-solid Q Topical ref (EU, USA, Asia, RoW),
TEFOSE 63 Ethylene glycol palmitostearate EP/NF/JPE (and) Q Q Q Q Q Q
in block (T, etc) Vaginal/rectal ref (EU, USA, Asia, RoW
PEG-32 stearate NF/JPE

2
 Excipients and solutions for RECTAL
Pharmaceuticals VAGINAL
Human and Veterinary applications ROUTES
(excluding Food producing animals)
May 02, 2012

Legend
d

(1) Market ref: Pharmaceutical ref disclosed in this section are in the public domain and so are not considered as confidential information
information.
For any additional info about these ref, please consult the document Tox and safety overview.

For any additional info about the regulatory status of these products, please consult the document Regulatory datasheet (RDS).

PHARMACOPEIA OTHER ref

EP: European Pharmacopoeia DMF: Drug master file. Gattefoss excipients have registered Type IV DMFs
USP-NF: US Pharmacopeia national formulary with the US FDA and Type III DMFs with Health Canada. Submission in other
JP: Japanese Pharmacopeia countries is possible upon request.
JPE: Japanese Pharmaceutical Excipient IIG: FDA Inactive ingredient guide. The ref listed in this table are not
Ch. P.: Chinese Pharmacopoeia exhaustive, please consult the FDA IIG website to have the full list of ref.
Handbook: Handbook, of pharmaceutical excipients

MARKET REFERENCES
EU: European Union
RoW: Rest of the world
ME: Middle East
ME: