HPE Drug stability: What do we need to know? | Page 7

COOH
COOH
O
O
COOH
COOH
C
C
+
H 2 2 0 O
CH 3 3
OH
HO
O
0
CH 3 3
O
H
N
O
C
H
N
S
S
N
O
H 2 2 O
H
O
O
OH
OH
S
S
HN
OH
OH
O
O
OH
OH
O
O
HO
HO
••
HO
HO
HO
••
HO
HO
HO
HO
O
O
O
O
HO
HO
HO
OH
N
N
H
H
O
H
H H
H
O OH
OH
OH O
S
S
N
O
O
O
H
H 3 3 C
C
CH 3 3
CH
CH
CH 3
OH
OH
OH
OH
O
OH
OH
HO
HO
3
H 3 C
C
CH 3 3 H
CH
3
N
N
CH
CH 3 3
H
H
OH
OH
H
H H
H
O
O OH
OH
CONH
CONH 2
2
OH
OH
O
OH
OH
CONH
CONH 2
2
O
O
O
O
N
N
H
N
O
O
N
N
S
S
CH
CH 3 3
O
O
O
O
HO
HO
+
CH 3 3
CH
N
N
H
O
O
O
O
COOH
COOH
HO
HO
COOH
COOH
OH
OH
H
C
H
H 2 2 N
C
O
O
OH
OH
H
N
O
O
S
S
N
CH 3 3
CH 3 3
CH
COO
COO
- -
NH
NH 2 2
C
C
H
C
C
O
H
H
N
N
O
O
S
HN
NH
NH
CH C
O
Conclusions
The main aim of this article is to explain how
quality of a drug product changes with time and
how factors such as temperature, humidity, light
and storage conditions can affect the shelf-life.
The ultimate task is to enhance professional
confidence of hospital pharmacists and help
them to be well informed and to make decisions
regarding drug formulations and storage
conditions.
References
1 Bardin C et al. Guidelines for
the practical stability studies of
anticancer drugs: a European
consensus conference. Ann
Pharm Fr 2011;69(4):221–31.
2 NHS Specialist Pharmacy
Service. Standard Protocol
for Deriving and Assessment
of Stability, Part 1: Aseptic
Preparations (Small Molecules),
Edition 4, April 2017 (Yellow
Cover). www.sps.nhs.uk/articles/
CH 3 3
Penicillin
polymer
Penicillin
polymer
CH 3 3
COO - -
COO
H
H
N
N
O
O
S
N
N
CH 3 3
CH 3 3
CH
COO
COO - -
standard-protocol-for-deriving-
and-assessment-of-stability-
part-1-aseptic-preparations-
small-molecules/ (accessed
August 2019).
3 Yoshioka S, Stella V. Stability
of Drugs and Dosage Forms.
Kluwer Academic/Plenum
Publishers, New York; 2000.
4 Loftsson T. Drug Stability
for Pharmaceutical Scientists.
Elsevier – Academic Press,
Amsterdam; 2014.
5 Sinko P (Ed). Martin´s Physical
Pharmacy and Pharmaceutical
Sciences. Lippincott Williams &
Wilkins, Baltimore, MD; 2011.
6 Evomela (prescribing
information) 2017. www.evomela.
com/ (accessed August 2019).
7 Savello DR, Shangraw RF.
Stability of sodium ampicillin
solution in the frozen and liquid
states. Am J Hosp Pharm
1971;28:745-51.
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