Agilent Technologies Enhancer Cell User manual

Agilent Enhancer Cell
Operator’s Manual

Notices
Manual Part Number
70-9072 Rev B
February 2020
Copyright
© Agilent Technologies, Inc. 2020
No part of this manual may be
reproduced in any form or by any means
(including electronic storage and retrieval
or translation into a foreign language)
without prior agreement and written
consent from Agilent Technologies, Inc.
as governed by United States and
international copyright laws.
Agilent Technologies, Inc.
3501 Stevens Creek Blvd.
Santa Clara, CA 95052 USA
Warranty
The material contained in this document
is provided “as is,” and is subject to being
changed, without notice, in future
editions. Further, to the maximum extent
permitted by applicable law, Agilent
disclaims all warranties, either express or
implied, with regard to this manual and
any information contained herein,
including but not limited to the implied
warranties of merchantability and fitness
for a particular purpose. Agilent shall not
be liable for errors or for incidental or
consequential damages in connection
with the furnishing, use, or performance
of this document or of any information
contained herein. Should Agilent and the
user have a separate written agreement
with warranty terms covering the
material in this document that conflict
with these terms, the warranty terms in
the separate agreement shall control.
Technology Licenses
The hardware and/or software described
in this document are furnished under a
license and may be used or copied only in
accordance with the terms of such
license.
Restricted Rights Legend
U.S. Government Restricted Rights.
Software and technical data rights
granted to the federal government
include only those rights customarily
provided to end user customers. Agilent
provides this customary commercial
license in Software and technical data
pursuant to FAR 12.211 (Technical Data)
and 12.212 (Computer Software) and, for
the Department of Defense, DFARS
252.227-7015 (Technical Data -
Commercial Items) and DFARS
227.7202-3 (Rights in Commercial
Computer Software or Computer
Software Documentation).
Safety Notices
CAUTION
A CAUTION notice denotes a
hazard. It calls attention to an
operating procedure, practice, or
the like that, if not correctly
performed or adhered to, could
result in damage to the product or
loss of important data. Do not
proceed beyond a CAUTION
notice until the indicated
conditions are fully understood
and met.
WARNING
A WARNING notice denotes a
hazard. It calls attention to an
operating procedure, practice, or
the like that, if not correctly
performed or adhered to, could
result in personal injury or death.
Do not proceed beyond a
WARNING notice until the
indicated conditions are fully
understood and met.

Enhancer Cell Operator’s Manual 3
Content
1 Introduction 5
Assembly Components 8
Unpacking Your Enhancer Cell Assembly 9
2 Operation 11
Membrane Selection Information for the Enhancer Cell 14
Ideal Characteristics for a Membrane 14
Examples of Membranes Used for In Vitro Release Tests 14

Content
4 Enhancer Cell Operator’s Manual
This page was intentionally left blank, except for this message.

Enhancer Cell Operator’s Manual 5
1Introduction
Assembly Components 8
Unpacking Your Enhancer Cell Assembly 9

1Introduction
6 Enhancer Cell Operator’s Manual
The Enhancer Cell Assembly, designed for research, quality control, and product
development laboratories, is a PTFE cell with adjustable volume and a screw cap
to retain the skin or artificial membrane. The assembly can be used with any
dissolution tester and is available with 4.0, 2.0, or 0.5 cm² surface area. Using the
Paddle-over-Enhancer-Cell method (see Figure 3, “Paddle over Enhancer Cell,” on
page 7) provides release rates comparable to Franz Cell technology. It provides
release rate data for quality control of topicals using readily available dissolution
apparatus, including 200 mL or standard 900 mL dissolution vessels.
The alignment tool (see Figure 1, “Enhancer Cell Assembly,” on page 6) is used to
hold the membrane in place and ensure the washer is centered properly while
using the adjustment tool to set the volume with the adjustment plate. When
purchasing more than one Enhancer Cell Assembly, one alignment tool is
required per size. The adjustment tool is universal and fits all sizes. Both the
alignment tool and the adjustment tool are required and must be ordered
separately. The Enhancer Cell Assembly does not include the vessel, paddle, or
membrane / skin.
Figure 1. Enhancer Cell Assembly
*not provided—for illustrative purposes only.
Retaining Ring
Washer
Membrane or Skin *
Adjustment Plate
with O-ring Cell Body R
Alignment Tool
Adjustment Tool

1Introduction
Enhancer Cell Operator’s Manual 7
Figure 2. Enhancer Cell Assembly Surface Areas
Figure 3. Paddle over Enhancer Cell
0.5 cm² 2 cm² 4 cm²

1Introduction
8 Enhancer Cell Operator’s Manual
Assembly Components
The Enhancer Cell Assembly consists of the following components (see
Figure 1, “Enhancer Cell Assembly,” on page 6):
•Retaining ring – secures the membrane or skin sample to the cell body and
ensures full contact with the sample.
•Washer – provides a leak-proof seal between the membrane, retaining ring,
and cell body.
•Membrane (not provided) – retains the sample in the sample
compartment. Usually an artificial membrane although some tests use
skin samples.
•Adjustment plate – allows control of the volume of the reservoir within the
cell body. This threaded part can be placed at the appropriate height for
each test and can be completely removed for easy cleaning. A Viton O-ring
prevents leakage.
•Cell body – provides a variable depth reservoir for the sample (semisolid,
solution, suspension, or emulsion) being tested.
Two additional tools are required to properly use the Enhancer Cell Assembly and
must be ordered separately:
•Adjustment tool – to move the adjustment plate.
•Alignment tool – to ensure the membrane is in proper contact with the
sample and the washer is properly centered.
This product is warranted to be free from manufacturing defects at the time of
delivery. Please report any problems upon receipt of merchandise to an Agilent
Customer Care Center. Contact information can be found www.agilent.com
under your country using the Contact Us link.

1Introduction
Enhancer Cell Operator’s Manual 9
Unpacking Your Enhancer Cell Assembly
1Carefully remove the Enhancer Cell Assembly.
2Ensure all of the following items were shipped with your Enhancer Cell:
If any item is damaged or missing, contact the Dissolution Systems Service
Department or your local Agilent representative for replacements.
•Enhancer Cell Assembly Operator’s Manual
•Retaining ring
•Washer
•Adjustment plate with O-ring
•Cell body
•Included if purchased separately:
•Adjustment tool
•Alignment tool

1Introduction
10 Enhancer Cell Operator’s Manual
This page was intentionally left blank, except for this message.

Enhancer Cell Operator’s Manual 11
2Operation
Membrane Selection Information for the Enhancer Cell 14

2Operation
12 Enhancer Cell Operator’s Manual
To use the Enhancer Cell Assembly, follow these steps:
1Using empty dissolution vessels and empty Enhancer Cell Assemblies, set the
appropriate paddle height. The recommended distance from the top of the
cell to the bottom of the paddle is 25 mm.
2Ensure the Viton O-ring is in place on the adjustment plate.
3Insert the adjustment plate into the cell body. Ensure the slot on the bottom of
the adjustment plate is oriented toward the bottom of the cell body.
4Using the adjustment tool, carefully screw the adjustment plate into the cell
body until the reservoir formed at the top is the approximate volume
necessary for the test.
5Fill the reservoir with the sample to be tested. Ensure the reservoir is filled to
the top in order to minimize the possibility of an air bubble forming between
the sample surface and the underside of the membrane. For semisolids, a
uniform surface can be obtained with the aid of a laboratory spatula.
6Place the membrane over the top of the sample compartment. It should be
large enough that the edges overlap the top of the cell body (between 2.5 and
2.8 cm). Ensure the membrane is free of wrinkles (which can occur if the
membrane is too large).
7Place the washer on top of the membrane, positioning it over the top edge of
the cell body. Place the retaining ring onto the cell body and carefully screw it
on the body until it just touches the washer. Do not fully tighten at this point.
8Carefully insert the end of the alignment tool with the indented edges into the
retaining ring until it is level and evenly seated. This process ensures the
washer is properly centered and presses the membrane tight against the
sample in the reservoir to prevent bubbles.
9With the alignment tool still in place, insert the adjustment tool in the
adjustment plate. Tighten the retaining ring until it is hand tight while giving a
slight clockwise turn with the adjustment tool. Remove the alignment and
adjustment tools.
NOTE
Always use care when disassembling, assembling or tightening
any part of the Enhancer Cell Assembly. The PTFE parts are
delicate and could be damaged by extreme force.
NOTE
Use only the special adjustment tool designed for use with the
adjustment plate. Using another type of tool or screwdriver may
damage the adjustment plate.

2Operation
Enhancer Cell Operator’s Manual 13
10 Carefully place the completed assembly into the bottom of the dissolution
vessel, with the membrane facing up. Add the appropriate preheated medium
and begin the test.

2Operation
14 Enhancer Cell Operator’s Manual
Membrane Selection Information for the
Enhancer Cell
Ideal Characteristics for a Membrane
Minimize resistance to drug transport
•High porosity
•Minimal thickness
•No drug binding
Examples of Membranes Used for In Vitro Release
Tests
•Regenerated cellulose (Dialysis membrane)
•Silastic membrane - polydimethyl siloxane
•Fluoropore FHLP hydrophobic membrane
•Ethylene vinyl acetate (Cotrans 9702)
•Skin (human, rat, rabbit, porcine, mouse)
•Cuprophan
•Carbosil
•Polysulfone

www.agilent.com
© Agilent Technologies, Inc. 2020
70-9072 Rev B February 2020
In This Book
•Chapter 1 Introduction
•Chapter 2 Operation