INDICES> propranolol for infant (2)

[David Woods <david.woods@stonebow.otago.ac.nz>]

INDICES> propranolol for infant (2)
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Hello Jo,

This information is from my CD ROM eMixt. See www.pharminfotech.co.nz.co.nz
for more information. Note you could give the injection orally for such a
small dose.Hope this helps.



Formulation in Pharmacy Practice   2nd Edition

----------------------------------------------------------------------------

PROPRANOLOL

Formula   Notes   References   Home Page
Propranolol is soluble in water and alcohol with a bitter taste.
Injections have a pH of 2.8 - 3.5.
Solutions of propranolol hydrochloride have optimum stability at about pH 3
and decomposition is rapid at alkaline pH.
Oral liquids are commercially available in some countries.

Formula A is based on manufacturer's recommendations and stability
studies.1  Formula B is a simpler alternative based on published stability
studies1,2,4 and evaluation of the literature.

Formula A

Propranolol Oral Liquid

Propranolol tablets qs
Sodium carboxymethylcellulose 1  g
Sodium citrate 0.21  g
Citric acid monohydrate 0.28  g
Syrup BP 25  mL
Parabens 0.1  %
Water to   100  mL

Expiry:  30 days

Storage:  Refrigerate.  Protect from light.

Shake well before use


Formula B

Propranolol Oral Liquid 5mg per mL

Propranolol tablets 40mg 12.5
Citric acid monohydrate 1  g
Parabens 0.1  %
Syrup or Glycerol 40  mL
Water to   100  mL

Expiry:  30 days

Storage:  Refrigerate.  Protect from light.

Shake well before use






NOTES
The extraction of propranolol hydrochloride from Inderal® tablets and
probably other brands is pH dependent being most efficient at low pH.2
Filtering out tablet excipients without acid extraction may remove
significant amounts of propranolol.  In the above formulations tablets
should be ground and mixed with some of the citric acid in solution to
improve extraction.
Sodium benzoate 0.1 - 0.2% could be used instead of parabens.
Other Formulations

A 1mg per mL oral liquid prepared from propranolol tablets and Roxane®
diluent was reported to be stable for four months at refrigerated or room
temperature in amber glass bottles.3
A 0.5mg per mL oral liquid prepared from tablets or injection in a base of
syrup, sodium benzoate 0.1% and citric acid was reported to be stable for
at least six months at 25°C in amber glass bottles.4
Due to the lack of microbial testing and evaluation of stabilty under in
use conditions, a maximum expiry date of 30 days is recommended for these
formulations.

REFERENCES
Ahmed GH, Stewart PJ, Tucker IG.  The stability of extemporaneous
paediatric formulations of propranolol hydrochloride.  Aust J Hosp Pharm
1988; 18 (5): 312-8.
Ahmed GH, Stewart PJ, Tucker IG.  Extraction of propranolol hydrochloride
from crushed tablets.
Aust J Hosp Pharm 1987; 17 (2): 95-8.
Henry DW, Repta AJ, Smith FM, White SJ.  Stability of propranolol
hydrochoride suspension compounded from tablets.  Am J Hosp Pharm 1986; 43:
1492-5.
Gupta VD, Stewart KR.  Stability of propranolol hydrochloride suspension
and solution compounded from injection or tablets.  Am J Hosp Pharm 1987;
44: 360-1.



Formulation in Pharmacy Practice
2nd Edition  © 2001 PharmInfoTech www.pharminfotech.co.nz/emixt.htm
ISBN 0-473-07577-6





David Woods
Lecturer/Drug Information Consultant,
School of Pharmacy
University of Otago
PO Box 913
DUNEDIN
NEW ZEALAND
00 64 3 479 7034 (fax)
00 64 3 479 5052 (phone)
025 271 7720 (mobile)
david.woods@stonebow.otago.ac.nz



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