Formulation in Pharmacy Practice - eMixt

Baclofen
 
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Properties
Baclofen has solubilities of 750mg per 100mL in water and 2.4mg per 100mL in ethanol.

Alternatives to compounding

Baclofen liquid (Lioresal®) is available in some countries.
Tablets or tablet fractions may disperse in water.

Compounded formulations
A New Zealand standardised formulation (10 mg/mL) is available Formula and Batch Sheet
This formula uses Ora-Blend/SF or Ora-Plus and Ora-Sweet/SF; 1:1 and is similar to formula A below.
Note: the standard strength for a compounded formulation in New Zealand is 10 mg/mL; the standard batch sheet should be used.


Formulas A and B are based on published studies.  Formula C is based on published stability information and may be used if the commercial suspending bases are not available or if a preparation with a syrup content lower than formula B is preferred.

 

Formula A2

Baclofen Suspension 10mg per mL
Baclofen tablets 10mg 120 
*Vehicle to   120  mL
* Vehicle
A 1:1 mixture of Ora Sweet and Ora Plus, or a 1:1 mixture of Ora Sweet SF and Ora Plus, or cherry syrup (cherry syrup concentrate diluted 1:4 with simple syrup).
Expiry:  30 days.
Stability:   These preparations are chemically stable for 60 days but microbial testing and stability under in use conditions were not evaluated.
Storage:  Refrigerate.  Protect from light.
Shake well before use.
Note
  1. The final pH of these formulations is 3.2 - 4.7.2
 

 

Formula B 1

Baclofen 5mg per mL
(NB in New Zealand please use standard formulation - see above)
Baclofen (Lioresal®) tablets 20mg 15 
Glycerol qs 
Syrup to   60  mL
Grind tablets, add sufficient glycerol to wet the powder and form a fine paste.  Gradually add syrup to volume.
Expiry:  30 days.
Storage:  Refrigerate.  Protect from light.
Shake well before use.
Notes
  1. If unpreserved syrup is used add 0.1% parabens.
  2. The formula was pleasant tasting with no after taste.
 

 

Formula C

Baclofen Liquid
 
Baclofen tablets qs 
Glycerol 20  mL
Syrup 10  mL
Methylcellulose 1% 50  mL
Parabens 0.1  %
*Citric acid qs 
Water to   100  mL
* If possible check the final pH.  If necessary add a small amount of citric acid (50 - 100mg) to bring the final pH approximately in the range 4 - 5.
Expiry:  30 days.
Storage:  Refrigerate.  Protect from light.
Shake well before use.
Note
  1. If the strength is less than 5 - 7.5mg per mL the baclofen should be in solution but a suspending agent is recommended as drug may be bound to insoluble excipients.  The drug's solubility in this system has not been evaluated.
 

 

References

  1. Johnson C.E., Hart S.M.   Stability of an extemporaneously compounded baclofen oral liquid.
    Am J Hosp Pharm 1993; 50: 2353-55.
  2. Allen L. V., Erickson M. A.  Stability of baclofen, captopril, diltiazem hydrochloride, dipyridamole, and flecainide acetate in extemporaneously compounded oral liquids. Am J Health-Syst Pharm 1996; 53 (Sep 15); 2179-2184.
  3. Stabilis database Baclofen
Formulation in Pharmacy Practice
Page Updated June 2014