Pharmaceutical composition comprising benzocaine with enhanced stability
A technology of benzocaine and stabilizer, applied in the field of pharmaceutical compositions, can solve the problems such as undesired synthesis of benzocaine derivatives
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Embodiment 1
[0068] Embodiment 1: preparation preparation
[0069] Four different tablet formulations were produced using the following ingredients:
[0070] Element
[g] Ingredients per 1000g
Sodium carboxymethyl cellulose
10.0
peppermint
5.0
Povidone K 25
10.0
20.0
Sodium Saccharinx 2 H2O
1.0
79.9
L-Lysine Monohydrate
0 / 1.5 / 3.0 / 10.0
872.7 / 870.7 / 869,2.7 / 859.2
Benzocaine
1.9
sum
1000g
[0071] Tablets of 1000 mg each are provided with the stated ingredients using the following method:
[0072] Sodium saccharin, benzocaine and povidone K25 were dissolved in 96% ethanol at room temperature to obtain drug solution 1.
[0073] Drug solution 1 was sprayed onto about 50% sorbitol in a fluidized bed system, and dried at 25-35° C. until ethanol evaporated to obtain dry material 1 .
[0074] The dry mass 1 was mixed with the remaining appro...
Embodiment 2
[0078] Embodiment 2: Analytical method
[0079] Analysis was performed using high pressure liquid chromatography (HPLC) according to Ph. Eur. 2.2.29.
[0080] The separation column is Kinetex C18, 150mm x 4.6mm. Eluent A was 20 mM sodium acetate in water, pH adjusted to 4.7 with acetic acid. Eluent B is acetonitrile. The applied gradient starts at 14 vol.-% eluent B and ends at 80 vol.% eluent B at a rate of about 1 ml / min. The injection volume was 15 μl.
[0081] Analysis was performed at 8°C by UV detection at 288nm and reference 400nm.
[0082] 0.5 g of the tablet of Example 1 was thoroughly dissolved in 50 ml of 25% acetonitrile. The control was a solution of 1.5 mg benzocaine in 100 ml 25% acetonitrile.
[0083] This control showed a peak at an elution volume of approximately 19 ml, which was determined to be undegraded benzocaine. Samples stored for 1 month showed additional peaks (B1 to B12) between elution volumes of 6.5 ml and 13 ml, with a distinct peak at 7.5...
Embodiment 3
[0084] Example 3: Results
[0085]
[0086] It was found that the presence of L-lysine monohydrate in a quantitative manner prevented the formation of impurities B1 to B12, especially of impurity B4, which was thought to represent the Maillard product of benzocaine with glucose.
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Abstract
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