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Pharmacies
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support necessary to succeed in
this rapidly changing industry.
Contents
SaltStable LS
Advanced™
by Humco
Compounding
SaltStable LS Advanced™
is an extension and
enhancement of
SaltStable Lo™.
SaltStable
LS Advanced™
Transdermal Study
New
Transdermal Study
STUDY
Evaluation of the Percutaneous Absorption of Ketamine HCl +
Gabapentin + Clonidine HCl + Baclofen, In SaltStable LS Advanced™,
Into Human Skin, In Vitro, Using the Franz Skin Finite Dose Model
Using Humco’s SaltStable LS Advanced™
the study was designed to evaluate the
percutaneous absorption pharmacokinetics
of ketamine HCl, gabapentin, clonidine HCl
and baclofen. Absorption was measured in
human epidermal cultures, in vitro, using
the finite dose technique and Franz Diffu-
sion Cells. The four drugs were selected
due to their frequent use in compounding
topical pain formulations along with
compounding multiple actives in
one formulation.
The formula was tested on standardized sections with Salt Stable LS,
transdermal compounding base, for the percutaneous absorption of
ketamine HCl, gabapentin, clonidine HCl and baclofen over a 48-hour
dose period. At pre-selected times after dose application, the dermal
receptor solution was removed in its entirety, replaced with fresh
receptor solution, and an aliquot saved for subsequent analysis. High
Performance Liquid Chromatography (HPLC) analyzed the samples.
RESULTS
Humco’s SaltStable LS Advanced™ is proven to deliver multiple drugs
beyond the stratum corneum, simultaneously into and through the
human skin after a single dose in the base. The absorption profiles in-
dicate a rapid penetration to a peak flux for gabapentin occurring at ap-
proximately 4 hours after dose application, and for baclofen occurring at
approximately 8 hours after dose application. The absorption profiles
indicate a steady penetration to a peak flux for ketamine HCl occurring
at approximately 12 hours after dose application, and for clonidine HCl
occurring at approximately 32 hours after dose application.
Study
Just Completed
SaltStable LS
Advanced™ Proven
to Deliver 8 Drugs
Simultaneously*!
Contact Us for Details
The Most
Scientifically
Advanced
Product on
the Market
Today!
Ketamine HCl ................................5%
Gabapentin ..................................10%
Clonidine HCl ............................ 0.2%
Baclofen ..........................................2%
SaltStable
LS Advanced™ ............. qs 100%
TESTED FORMULA
ADDITIONAL FORMULAS TESTED
Baclofen .............................................2%
Bupivacaine HCl ...........................1%
Cyclobenzaprine HCl ..................2%
Diclofenac Na .................................5%
Gabapentin........................................6%
Ibuprofen ............................................3%
Ketamine HCl .................................10%
Pentoxifylline ..................................3%
SaltStable
LS Advanced™ .................q.s. 100%
Diclofenac Na .................................5%
Ibuprofen ............................................3%
Pentoxifylline ..................................3%
Verapamil HCl ...............................10%
SaltStable
LS Advanced™ .................q.s. 100%
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page 31
page 33
Pharmacy
Compounding
Policy & Procedure
by R.J. Hedges &
Associates
At R.J. Hedges & Associates,
we make a commitment to
our clients.
OptiFill Provides
a Comprehensive
Technology Solution
for Complex
Fulfillment Challenges
tailored to market segment and
individual client needs, optiFill
is a highly configurable family of
technologies. no two installations
are identical.
Are you prepared for the upcoming FDA Compounding Regulations?
Do you have a Compounding Policy and Procedure Manual?
Do you have your compounding lab set up correctly?
R.J. Hedges & Associates’ Pharmacy Compounding Program provides your pharmacy with
up to date policies and procedures for non-sterile compounding that follows the standards
of the USP <795>, USP <797>, Pharmacy Accreditation Compounding Board (PCAB™) and
the Food and Drug Administration.
R.J. Hedges & Associates Pharmacy Compounding Policy and
Procedure Program includes:
• Easy to read and follow Policies and Procedures
• Regulatory Compliance
• Personnel Management for hiring and specific position responsibilities
• Facility and Equipment Management
• OSHA rules and regulations for chemical and
compounding preparation
- Bloodborne Pathogen Plan
- Hazard Communication Plan
• Compounding Recordkeeping
• Beyond-Use Dating Procedures
• Product Safety, Labeling and Shipping
• Patient Education
• Total Quality Management (TQM)
• Computer Based Training Videos
For Orders or More Information:
Phone: 724-357-8380 | Email: info@rjhedges.com | Web: www.RJHedges.com
Pharmacy
Compounding Policy
and Procedure Program
“Your ComplianCe experts for
todaY and tomorrow”™
Pharmacy Compounding
Program
Order Your
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page 35
page 37
USP BET Compliant
Endotoxin Testing
for Compounding
Pharmacies by Associates
of Cape Cod, Inc.
Associates of Cape Cod, Inc. (ACC)
is an industry innovator and global
supplier of endotoxin and glucan
detection products and services.
Testing For Endotoxins?
Reference:
1Bacterial Endotoxins Test. Chapter <85>. USP 35, p. 88-92, 2011, United States Pharmacopeial Convention,
Rockville, MD, USA.
Incubating Kinetic Tube Reader
Pyros Kinetix® Flex
USP BET Requirements
Tube Readers
A. Sample solution (without added endotoxin), ≥ 2 replicates
B. Sample solution with endotoxin added to give a concentration
P
from the middle of the standard curve, ≥ 2 replicates
C. At least three standard endotoxin concentrations,
≥ 2 replicates of each
D. Water for BET (negative controls), ≥ 2 replicates
For fully USP BET1 compliant
endotoxin tests, use ACC’s new
Pyros Kinetix® Flex
USP Bacterial Endotoxins Test1 Requirements for Photometric
Quantitative Techniques (Test for Interfering Factors/Test Procedure)
Associates of Cape Cod, Inc. offers a USP
BET1 compliant endotoxin testing system!
888.395.2221 • www.acciusa.com
FREEDOMRXINC.COM • 877.839.8547
Knowledge. Support. Supply.
Freedom Pharmaceuticals
Our name speaks for itself. Freedom... Freedom to choose. Freedom to compound. Freedom you deserve. Freedom
Pharmaceuticals provides you with the highest quality pharmaceutical products and services available and gives
you the personalized customer service your pharmacy requires.
Freedom Pharmacy Support Services (FPSS)
FPSS offers comprehensive pharmacy compounding support, providing the knowledge, tools, and counsel needed
to make compounding pharmacies prosper.
CPCSI - Insurance/Third-Party Support, Guidance & Consulting
Our consultants consist of Lawyers, Pharmacists and former PBM Auditors that work together to teach your
pharmacy how to properly bill third parties for compounded prescriptions.
page 45
page 47
Pain-free Data Solutions
from InfoWerks Data
Services, Inc.
InfoWerks provides an unmatched
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We also deliver this—the same kind
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as amazed one company
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“
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• Best-in-Class Pharmacy Data Conversions
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• Specialized Printing Services
Start making your pharmacy data services management pain-free.
Go to infowerks.com or call Jef at 702-429-3751.
page 39
Trade Show
& Meeting
Calendar
page 40-43
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