Table 2.

Physicochemical and microbiological parameters of the cream over 6 months: (A) Physical; (B) microbiological; (C) chemical stability of lidocaine and pH variation; (D) chemical stability of preservative components

(A)	N	D0		D7		D15		D30		D90		D180
		25°C	40°C	25°C	40°C	25°C	40°C	25°C	40°C	25°C	40°C	25°C	40°C
Colour	3	White	White	White	White	White	White	White	White	White	White	White	White
Odour	3	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil
Phases separation after centrifugation	3	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil
Average size of the emulsions±SD (µm)	3	14.23± 5.5	15.23±6.2	16.03±5.6	14.85±4.9	16.37±6.3	15.14±4.9	14.08±7.1	16.17±6.2	15.49±5.4	17.13±4.4	15.42±6.8	16.36±5.9

(B)	N	D0		D7		D15		D30		D90		D180
		25°C	30°C	25°C	30°C	25°C	30°C	25°C	30°C	25°C	30°C	25°C	30°C
Total aerobic micro-organism count (colony-forming units/10 mL)	3	<5	<5	<5	<5	<5	<5	<5	<5	<5	<5	<5	<5
Specified germs (Escherichia coli, Staphyloccocus aureus and Salmonella)	3	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil	Nil

(C)	N	D0		D7		D15		D30		D90		D180
		20°C	40°C	20°C	40°C	20°C	40°C	20°C	40°C	20°C	40°C	20°C	40°C
Lidocaine (CR) (m/m±SD) (%)	3	25.5±1.6	25.5±1.6	22.8±0.8	25.5±0.6	23.9±1.8	24.7±1.9	23.1±1.4	24.3±1.1	23.8±3.4	23.3±1.7	24.9±1.9	24.2±2.1
pH variation	3	4.79	4.79	4.86	4.87	4.84	4.9	4.87	5.02	5.1	5.2	5.5	5.5

(D)	N	D0		D7		D90				D180
		20°C	40°C	20°C	40°C	20°C		40 °C		20 °C		40°C
MB (Av±SD) (µg/mL)	3	7.76±0.18	7.76±0.18	–	–	–		–		7.46 ± 1.05		7.71±0.65
PB (Av±SD) (µg/mL)	3	1.59; 5.6	1.59; 5.6	–	–	–		–		1.43 ± 0.72		1.45±1.3
DU (Av±SD) (µg/mL)	3	15.33±2.8	15.33±2.8	–	–	–		–		14.55 ± 2.33		12.69±4.67

Av, Average; CR, cream drug product; D, day,