Formulation and Evaluation of Berberine HCl as Niosomal Drug Delivery System

 

Pooja S. Awate*, Tejashree P. Pimple, Jeeja F. Pananchery, Ashish S. Jain

Shri D. D. Vispute College of Pharmacy and Research Center, Panvel-410206, Dist - Raigad (M.S), India.

*Corresponding Author E-mail: poojjaawate95@gmail.com.

 

ABSTRACT:

Non-ionic surfactant based vesicles known as niosomes. Vesicular system are lamellar structure, which delivery both the drug (hydrophobic and hydrophilic), encapsulated into interior hydrophilic compartment and outer lipid layer respectively. Berberine HCl noisome gel formulation show anti-microbial activity. Berberine HCl is an isoquinoline alkaloid which shows anti- microbial activity on various bacteria and fungi. The formulation of Berberine HCl noisome was prepared by using thin-film hydration technique by using different concentration of non-ionic surfactant span60 and cholesterol with optimized various process variables. The optimized gel formulation of niosomes was characterized for entrapment efficiency, particles size, transmission electron microscopy, zeta potential and in-vitro drug release study. The stability study was performed at various temperature.

 

KEYWORDS: Berberine HCl, Niosome, Lamellar, Encapsulated.

 

 

 

INTRODUCTION:

In 1909, Paul Ehrlich initiated the development for target delivery. Niosomes were first discovered by handjanivila in 1979. The biologic origin of phospholipid vesicles or liposomes, prepared with variety of phospholipids were first described by British Hematologist Alec Douglas Bangham.The first report of non-ionic surfactant vesicles came from the cosmetic incorporating the drug into noisome for better targeting of the drug at appropriate tissue destination is widely accepted by researchers.

 

Non-Ionic surfactant based vesicles known as niosome. Non-ionic are less irritation power. Niosome are lamellar structures microscopic in size. The surfactant molecules trend to orient themselves in such a way that the hydrophilic ends of the non-ionic surfactant point outwards, while hydrophobic ends face each other to form the bilayer.

 

Vesicular systems are noval means of delivering drug in controlled manner to enhance bioavailability and to get therapeutic effect over a longer period of time. Vesicular systems are lamellar structures made up of amphiphilic molecules surrounded by an aqueous compartment. Vesicular systems useful for the delivery of both drug (hydrophobic and hydrophilic) which are encapsulated into the interior hydrophilic compartment and the outer lipid layer respectively. They have longer shelf life, stability and ability to delivery drug at target site in controlled or sustained manner which enchance bioavailability. Non-ionic are used due to enhance solubility, to increase bioavailability, fluidity and permeability of poorly water soluble drugs.

 

Berberine Hydrochloride is a quaternary protoberberine isoquinoline alkaloid derived from the root and stem bark of plant such as hydrastis Canadensis (goldenseal), Berberisaristata (treetumeric), Berberis vulgaris (berberry) Family: Berberidaceae. Berberine HCl, the major ingredient of these herbs possesses potent anti-microbial activity against various bacteria. Berberine HCl is damage the integrity of bacterial membrane and affect the metabolic activity which also inhibits the synthesis of protein and DNA, cause to bacteria to die[3].

 

Orally administration of berberine HCl cause poor bioavailability and increasing dose often elicits gastro-intestinal side effects. Topical drug delivery has a lot of advantage over conventional dosage form and controlled release delivery system it also avoid first pass metabolism, improve the patient compliance, stability. Thus to improve the antimicrobial effect of berberine HCl, niosomal topical gel of berberine HCl was formulated and studied.

 

MATERIAL AND METHODS:

Chemical and reagents:

Material and chemicals was are of analytical grade and manufactured and supplied from different sources. Berberine HCl was purchased from Yucca Enterprises, Mumbai. Span 60, cholesterol, chloroform, methanol, Disodium hydrogen phosphate and sodium phosphate, carbopol 934 was purchased from Research-Lab Fine chem Industries, Mumbai, India.

 

PERFOMULATION STUDIES:

Performulation study is the first stage before begins the drug development. Performulation studies characterize the physical and chemical properties of the drug molecule in order to develop safe, effective and stable formulation. To establish the compatibility with excipients, stability and store to ensure their quality.

 

Ultraviolet Visible (UV-Vis) Spectrophotometery:

Preparation of standard stock solution of drug (Methanol and phosphate buffer pH 6.8):

Weight accurately 10mg of Berberine HCL and transfer in two different flask of 100ml. In first flask, dissolve drug in 2ml of methanol and make up the volume with methanol. In second flask, dissolve drug in 2ml of phosphate buffer pH 6.8 and make up the volume with phosphate buffer 6.8 to obtain the concentration of 100 ppm. This solution was used as standard stock solution.

 

Determination of λmax of drug (Methanol and phosphate buffer pH6.8):

Pipette out 1ml of the standard stock solution in 10ml volumetric flask from respective flask and make up the volume with methanol and phosphate buffer 6.8 separately. Scan the sample between wavelength 200nm to 400nm and determine the λmax.

 

Plotting of calibration curve of drug (Methanol and phosphate buffer 6.8):

From the standard stock solution, series of dilution were made by pipetted out 0.3, 0.6, 0.9, 1.2 and 1.5ml and transfer into 10ml volumetric flask, make up the volume with methanol to obtain 3, 6, 9, 12 and 15ppm solution respectively. Absorbance wasmeasured at 348nm by using UV-Vis Spectrophotometer. This experiment was performed in triplicate and calibration curve was plotted in order to check the linearity. Same procedure follows for phosphate buffer pH 6.8.

 

Drug-Excipients Compatibility Study by Fourier Transform Infra-Red (FTIR) Spectroscopy:

FTIR spectrum of Berberine HCl and all excipients are taken individually and mixture of Berberine HCl and excipients were recorded and the compatibility of the Berberine HCl with excipients were also recorded.

 

Optimization of Niosomes[4,5]:

Optimization techniques are used in pharmaceutical industry before preparation of formulation. This is first step under taken by using independent variable on process variables which could affect the preparation and different characteristics of niosomes. It is mathematical programming for selection of best variable from some sets of variables. Optimization was done for selecting entrapment efficiency of drug and particle size of niosomes during manufacturing process.

 

Effect of variables on the formulation:

Volatile organic solvent:

Different solvents were used such as methanol, ethanol, chloroform were tired and observe that the berberine HCl and excipients solubility in all solvents and problem related with solvents and the combination of the solvents were also observe.

 

Hydrating medium:

Phosphate buffered (pH 6.8) used as hydrating medium were tried.

 

Solvents and Medium volume:

Volume of solvents and hydrating medium should be added according to solubility of drug, excipients and film formation.

 

Effect of variables on the process:

Temperature:

Temperature effect on berberine HCl, excipients, film formation and its stability were observe by performing the experiment at different temperature such as 30oC, 60oC, 70oC and also at room temperature.

 

Rotational speed of flask:

Rotational speed of the flask was adjusted at different rpm to observe the uniformity of film. Film formation depends on the rotational speed of flask.

 

Hydration time:

Hydration also done at different time period and effect on the film was observed.

 

Sonication time:

Niosomal dispersion was sonicated on bath sonicator at different time. Sonication convert MLVs into decrease size of vesicles and particle size.

 

Preparation of Niosomes (By Thin Film Hydration Method) [6]:

·       After optimization of formulation variables and process variables and selection of excipients for preparation of niosomes. Niosomes were prepared by thin film hydration technique (rotary flash evaporatory).

·       Weight accurately berberine HCl, Cholesterol, Span60 in different proportion as shown in table no.1 and transfer in beaker to dissolve in 10ml volatile organic solvent (Chloroform) and transfer to 250 ml round bottom flask after dissolving.

·       The assembly of rotary flash evaporator are setup and mixture of solvent was evaporated under vacuum of up to 400mm Hg at a temperature 600C.To get a thin film, dry and smooth lipid was obtained.

·       It was kept in desiccators for complete removal of organic solvent.

·       The dried layer was hydrated by phosphate buffer pH6.8 with gentle shaking and resulted into the formation of niosomal dispersion.

 

 

Table no. 1: Formulation table of Berberine HCl Niosomes

Sr. No

Formulation code

Berberine HCl (mg)

Span 60: Cholesterol

Speed (rpm)

Hydration time (min)

1.

F1

50

1:1

60

50

2.

F2

50

2:1

60

50

 

F3

50

3:1

60

50

4.

F4

50

3:2

60

50

5.

F5

50

3:2

70

60

6.

F6

50

3:1

70

60

7.

F7

50

2:1

70

60

8.

F8

50

1:1

70

60

 

 

 

Separation of unentraped material:

By Dialysis Method:

Dialysis bag is used to separate the unwanted material and free unentraped drug from niosome dispersion. The dispersion was put into the dialysis bag which has to sealed from both the ends. The sealed bag was suspended into a beaker containing dialysis medium such as phosphate buffer pH 6.8 and which is constantly stirred by magnetic stirrer until all free material and unwanted material is remove from dispersion of niosome.

 

Evaluation of formulated Niosomes[7-9]:

Visual Appearance:

Niosomal dispersion was visually checked for its appearance, turbidity, flocculation and phase separation was also checked by placing the niosomal dispersion in transparent container.

 

Optical Microscopy:

Niosomal dispersion was observed under microscope to observe the shape of niosomal vesicles. A drop of dispersion was taken on glass slide and it was cover by cover slip. It was observed under 10X eye piece and 45X objective lens.

 

Entrapment Efficiency[8]:

Entrapment efficiency (EE%) is defined as the portion of the applied drug which is entrapped by the niosomes. Unencapsulated free drug can be removed from the niosomal solution using centrifugation by using dialysis method. After this step the loaded drug can be released from niosomes by destruction of vesicles. Niosomes can be destroyed with the addition of 0.1% Triton X-100 or 50% propanol to niosomal suspension. The loaded and free drug concentration can be determined by a UV spectrophotometer. The following formula is used to calculate the entrapment efficiency:

                                 Amount of entrapped drug

Entrapment =        ------------------------------------- X 100

Efficiency (EE%)     Total amount of added drug

 

Electron Microscopy:

Transmission electron microscopy (TEM) was used to determine the morphology of the niosomal vesicles. Few drops of optimized niosomal were deposited on a carbon-coated copper grid and examined under transmission electron microscope.

 

Size Dispersion, Poly Dispersity Index and Zeta potential Measurement:

Size Dispersion and Poly Dispersity Index (PDI) was determine by using Dynamic light scattering. Zeta potential of dispersion is measured by applying an electric field across the dispersion. Particles within the dispersion will migrate towards the electrode of opposite charge with a velocity proportional to the magnitude of the zeta potential.

 

In-vitro drug release studies[10]:

In-vitro drug release studies of Berberine HCl Niosomes gel were carried out using Franz diffusion cell. The receiver compartment contained phosphate buffer pH 6.8 and in upper compartment 0.250gm of formulation were spread uniformly on goat skin membrane. The receptor compartment containing phosphate buffer was continuously stirred with the help of magnetic stirrer and temperature was maintained at 370C ±1oC by circulating water continuously during experiment. Sample was withdrawn at suitable time intervals and replace with equal amounts of fresh phosphate buffer. Sample were analysed spectrophotometrically and the percent cumulative drug release was calculated.

 

Anti-microbial studies:

Minimum Inhibitory Concentration (MIC)[11]:

Minimum Inhibitory Concentration is the lowest concentration of anti-microbial agent that can inhibit the growth of micro-organisms after overnight incubation. In a series of six test tube of different micro-organism add sterile nutrient agar broth (10ml). Pipette out 0.1ml of culture add into each test tube according to test tube marked of micro-organism and pipette out 1ml from stock solution Berberine HCl of 100ppm solution, add into each test tube. Incubate test tube in incubator of Pseudomonas aeruginosa, Bacillus subtilis, Staphylococcus aureus at 35ᵒC for 24 - 48 hours and Candida albicansat 25ᵒC for 72 hours.

 

Cup-plate method [12]:

Cup-plate method was used to determine the anti-microbial activity of Berberine HCl, Berberine HCl Gel and Optimized Berberine HCl Niosomal Gel. Muller-Hinton agar was used as medium and petri plate, medium was sterilized in autoclave at 15psi, 1200 C for 15min. Micro-Organism used are same given in MIC. Medium was then pour in sterilized petri plate, 2-3drops of culture were added on solidified medium and spread by spread by spreader then well were made by sterile cork borer. Test solution and positive control (0.1ml) were added in respective borer. Petri plate were incubated at 370 C and Zone of inhibition was observed and measured.

 

Models for Drug Release Studies[13]:

1.     Zero Order Kinetic Model:

Zero order describes the system where the release rate of drug is independent of its concentration. The equation is

 

C=Co-Kot

 

Where,

C= Amount of drug release or dissolved. Co = Initial amount of drug in solution. Ko = Zero order rate constant.

t = Time.

 

For study of release kinetics, the graph plotted between % drug released verse time.

 

2.     First Order Kinetic Model:

First order describes the absorption and elimination of the drug, The drug release which follow the first order kinetic can be expressed by equation:

 

logC= logCo-Kt/2.30

 

Where,

Co= Initial concentration of drug. K =First order constant.t= Time.K/2.303= Slope of straight line.

 

The data obtained are plotted as log % drug remain verses time.

 

3.     Higuchi Model:

Higuchi model of optimizied noisome gel was obtained by following equation:

 

Q= KH t1/2

 

Where,

Q= Cumulative amount of drug released in time t.KH= Higuchi dissolution constant.

 

The data obtained are plotted as %drug release versus square root of time.

 

4.     Korsmeyer-peppas Model:

Korsmeyer-peppas model of optimiziedniosome gel was obtained by following equation:

 

Log (Mt/M∞) = logKKP+nlog t

 

Where,

Mt is the amount of drug released at time t.

M∞ is the amount of drug released after the time ∞.

n is the diffusional exponent or drug release exponent.

KKP is the Korsmeyer-peppas release rate constant.

In Korsmeyer-peppas model, log% drug release verse log time was plotted.

 

Stability study [14]:

The stability of niosomes can be evaluated by determining mean vesicle size, size distribution, and entrapment efficiency over several month storage periods at different temperatures. During storage the niosomes are sampled at regular intervals of time and the percentage of drug which is retained into the niosomes is analyzed by UV spectroscopy. The stability study of formulation can be performed as per International Council for Harmonisation (ICH) guidelines.

 

RESULT AND DISCUSSION:

Identification and Confirmation of Drug:

Organoleptic properties:

Berberine HCl was found to be yellow solid powder.

 

Drug solubility:

Berberine HCl is sparingly soluble in methanol, slightly soluble in ethanol, very slightly in water and soluble in phosphate buffer pH6.8.

 

 

 

Ultraviolet Visible (UV-Vis) Spectrophotometry:

 

Figure No.1: UV-Vis spectra of Berberine HCl

 

After studying the UV spectra of Berberine HCl, it was found that it showed maximum absorbance at 348nm.

 

Fourier Transform Infra-Red (FTIR) Spectroscopy:

 

Figure no.2: IR spectra of Berberine HCl

 

Table no. 2: IR spectrum peaks of Berberine HCl

Peaks (cm-1)

Groups

Type of Vibration

Frequency (cm-1)

1269.16

O-C

Ether

1300-1000

1498.69,1377

C-H

-CH3 (bend)

1450 and 1375

1220.94

C-N

Amine

1350-1000

1604.77

C=C

Alkene

1680-1600

650,721,827

C-H

Aromatic(out-of-plane-bend)

600-690

962.48, 916.19

C-H

Alkene (out-of-plane)

1000-650

 

 

 

Performulation Study:

Ultraviolet Visible (UV-Vis) Spectrophotometry

Spectrometric scanning and determination of λmax of Berberine HCl (in methanol and phosphate buffer pH 6.8):

 

Figure no.3: UV-Vis spectra of Berberine HCl (in methanol)

 

Figure no.4: UV-Vis spectra of Berberine HCl (in phosphate buffer pH6.8)

 

 

UV-Vis spectrum analysis of Berberine HCl showed highest peak at 348nm which is considered as maximum absorbance (λmax) for Berberine HCl and solvent was methanol and phosphate buffer pH 6.8.

 

Plotting of calibration curve of Berberine HCl (in methanol):

The concentration from 3ppm to 15ppm of Berberine HCl in methanol was selected for calibration curve. The value of R2 was found to be 0.999 indicating the relation of drug concentration and absorbance was linear in selected range.

 

Table no.3: Observation table of calibration curve of Berberine HCl (in methanol)

Concentration (ppm)

Absorbance (at 348)

0

0

3

0.171

6

0.355

9

0.532

12

0.694

15

0.873

Number of observation= 3

 

Figure no.5: Calibration curve of Berberine HCl (in methanol)

 

 

Plotting of calibration curve of Berberine HCl (in phosphate buffer pH6.8):

The concentration from 3 ppm to 15 ppm of Berberine HCl in phosphate buffer pH6.8 was selected for calibration curve. The value of R2 was found to be 0.999 indicating the relation of drug concentration and absorbance was linear in selected range.

 

Table no.4: Observation table of calibration curve of Berberine HCl (in phosphate buffer pH6.8)

Concentration (ppm)

Absorbance (at 348)

0

0

3

0.171

6

0.376

9

0.568

12

0.777

15

0.950

Number of observation= 3

 

Figure no.6: Calibration curve of Berberine HCl (in phosphate buffer pH6.8)

 

Drug-Excipient Compatibility Study by Fourier Transform Infra-Red (FTIR) Spectroscopy:

IR spectrum of Berberine HCl, excipients and correlation between them indicating that the drug was compatible with the formulation excipients was recorded by FTIR and the data of the drug with excipients suggested that there is no interaction between the Berberine HCl and all excipients.

 

Figure no.7: IR spectra of Berberine HCl and Excipients

 

Table no.5: IR spectrum peaks of Berberine HCl and Excipients

Peaks (cm-1)

Groups

Types of Vibration

Frequency

(cm-1)

1608.63

C=C

Alkene

1608

1450

-CH3

Alkane(bend)

1450

1269.16, 1222.87, 1103.92, 1031.92

C-O

Carboxylic acid

1300-1000

655.80, 599.80, 545.85, 464.84

C-H

Aromatic(out-of-plan-bend)

900-690

918.12, 817.82,

721.38

C-H

Alkene(out-of-plan-bend)

1000-650

 

Optimization:

Effect of variables on the formulation:

Volatile organic solvent:

Different solvents such as methanol, ethanol, and chloroform were tried. The problem was associated with solvent or combination of solvents observed was insolubility. In chloroform, span 60 and cholesterol were soluble.

 

Hydrating medium:

Phosphate buffered (pH 6.8) used as hydrating medium was found to be suitable for hydration.

 

Solvent and medium volume:

Volume of solvents and hydrating medium should be added according to solubility of drug, excipients and film. Excess volume increase evaporation and time it may affect improper film formation.

 

Effect of variables on the process:

Temperature:

Temperature can also cause stability problem on drug, excipients, film formation. Proper temperature was selected 60oC, 70oC.

 

Rotational speed of flask:

Uniformity of film depends and its thickness depends on the rotational speed of the flask. Speed 120rpm was found to be adequate for formation of film and to produce thick film.

 

Hydration time:

Hydration time half hour until milky niosomal dispersion and over hydration can cause disruption of vesicles.

 

Sonication time:

Niosomal dispersion was sonicated by bath sonicator for different time period. Uniform vesicles were formed when niosomal dispersion was sonicated for 10 min. when sonicated time was increase niosomes vesicles damaged.

 

Evaluation of Niosomes:

Visual Appearance:

Niosomal dispersion was visually checked for its appearance, turbidity, flocculation and phase separation was also checked by placing the niosomal dispersion in transparent container. Formulation F1, F2, F3, F4, F5, F6, F7 and F8 was formulated. Optimized formulation F6 shows no turbidity, flocculation and phase separation.

 

Optical Microscopy:

Surface morphology was studied by optical microscopy. The morphology of the optimized formulation was observed. The optical micrographs showed vesicles with uniform spherical shape of batch F6.

 

Figure No.8: Niosomal suspension (F6)

 

Entrapment Efficiency:

Entrapment efficiency of optimized formulation F6 was found be 88±0.09%.

 

Electron Microscopy:

Transmission electron microscopy (TEM) was used to determine the morphology of the niosomal vesicles.

 

Figure No. 9: Transmission electron microscopy of optimized niosomal Formulation (F6)

 

Size Distribution and Poly Dispersity Index (PDI):

 

Figure No.10: Size Distribution and Poly Dispersity Index (PDI) of F6 formulation

 

Vesicle size and size distribution of optimized formulation (F5) were determined by light scattering method using Zeta sizer (Zeiss). The mean vesicle diameter was found to be 2509.4nm and size distribution curve confirms the normal size distribution of the vesicles.

 

Zeta potential Measurement

 

Figure No.11: Zeta potential of niosome (F6)

 

Zeta potential of formulation (F6) was determine by using Zeta-sizer. Zeta potential was found to be 0.5mV.

 

In-vitro Diffusion Study:

In-vitro Diffusion Study of optimized niosomal Gel was carried by using Franz diffusion cell using goat membrane as diffusion membrane and phosphate buffer pH6.8 as a medium. The % drug release of Berberine HCl niosomal gel and Berberine HCl Gel was found to be 87.91 and 78.15 over period of 4hours30min. Graphically comparison of % drug diffusion of Berberine HCl niosomal gel and Berberine HCl Gel was shown in figure no.12 and table no.6.

 

Table no.6: % Drug Release of Berberine HCl Niosomal Gel (F6) and Berberine HCl Gel

Time (min)

% Drug Release of Berberine HCl Niosomal Gel (F6)

%Drug Release of Berberine HCl Gel

30

19.14±0.56

16.66±0.45

60

28.72±0.47

23.33±0.23

90

32.97±0.34

32.22±0.15

120

34.04±0.56

34.38±0.27

150

36.17±0.36

36.66±0.48

180

40.42±0.85

41.10±0.43

210

52.12±0.33

49.99±0.67

240

68.89±0.23

65.54±0.34

270

80.59±0.12

76.66±0.38

300

86.91±0.43

78.15±0.46

 

Figure no.12: Graphical Comparison of Berberine HCl Niosomal Gel of all Formulation and Berberine HCl Gel for % drug content

 

 

Antimicrobial Activity:

1.     Minimum Inhibitory Concentration (MIC):

Table no.7: Observation table of Minimum Inhibitory Concentration (MIC)

Bacterial culture

Concentration of Berberine HCl

 

1ppm

2ppm

3ppm

4ppm

5ppm

6ppm

Pseudomonas aeruginosa

Turbidity

turbidity

turbidity

turbidity

Slightly turbidity

Noturbidity

Candida albicans

Turbidity

turbidity

turbidity

turbidity

Slightly turbidity

No turbidity

Bacillus subtilis

Turbidity

turbidity

turbidity

turbidity

Slightly turbidity

No turbidity

Staphylococcus aureus

Turbidity

turbidity

turbidity

turbidity

 Slightly turbidity

 No turbidity

 

 

 

Figure No.13: Minimum Inhibitory Concentration (MIC)

A) Pseudomonas aeruginosa B) Staphylococcus aureus C) Candida albicans D) Bacillus subtilis

 

2.     Cup-plate method:

Table no.8: Zone of Inhibition

Bacterial culture

Zone of inhibition(mm)

Berberine HCl

Berberine HCl Niosomal Gel

Berberine HCl Gel

Pseudomonas aeruginosa

29±0.6

33±0.95

28±0.87

Candida albicans

28±0.96

35±0.45

30±1.05

Bacillus subtilis

30±0.59

31±1.02

26±0.68

Staphylococcus aureus

26±0.90

34±0.35

29±0.12

 

 

 

Figure No.14: Antimicrobial Activity of Berberine HCl, Berberine HCl Niosomal Gel, Berberine HCl Gel (F6)

A) Pseudomonas aeruginosa B) Candida albicans C) Bacillus subtilis D) Staphylococcus aureus.

 

 

Figure no.15: Graphical Representation of Different Kinetic model of Berberine HCl Niosomal (F6)

 

 

 

Models for Drug Release Studies:

The kinetic of drug release of optimized Niosomal gel formulation was found to be fitted in zero order model compare to other models on the basis of their highest regression coefficient. (Fig. 15).

 

Stability Study [14]:

The accelerated stability studies were performed according to ICH guidelines for 3 months and results were found to be stable in varying temperature. Stability study was carried out on optimized Niosome.

 

Table no.9: Stability study of Berberine HCl Niosome (F6) (Refrigeration temperature)

Period (months)

Storage condition

Parameters evaluated

Physical appearance

%Drug content

pH

0

5±3oC

Yellow

82.95%

7.41

1

5±3oC

Yellow

82.23%

7.25

2

5±3oC

Yellow

82.13%

7.33

3

5±3oC

Yellow

81.99%

7.31

Table no.10: Stability study of Berberine HCl Niosomal Gel (F6) (Room temperature)

Period

(months)

Storage condition

Parameter evaluated

Physical appearance

%Drug content

pH

0

25±2oC

Yellow

82.85%

7.21

1

25±2oC

Yellow

82.45%

7.30

2

25±2oC

Yellow

81.75%

7.32

3

25±2oC

Yellow

81.52%

7.42

 

ACKNOWLEDGEMENTS:

The corresponding author is thankful to Mrs. Jeeja F. Pananchery (Research Guide) and Dr. Ashish Jain (Principal) from Shri D. D. Vispute College of Pharmacy and Research Center, Panvel. India for valuable guidance and for providing excellent facilities to conduct the research.

 

CONFLICT OF INTEREST:

Authors declare that there is no conflict of interest.

 

CONCLUSION:

In present research work, Berberine HCl formulation was successfully prepared by thin film hydration method to observe the effect of Drug: non-ionic surfactant: Cholesterol on vesicle size and entrapmentefficiency. Niosomal gel were formulated of optimized ratio and evaluated for various parameters, so to get optimized drug release, efficiency and to improve the anti-bacterial activity, residence time, skin penetration.

 

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Received on 10.02.2020          Modified on 02.03.2020

Accepted on 08.04.2020   ©Asian Pharma Press All Right Reserved

Asian J. Pharm. Res. 2020; 10(3):149-159.

DOI: 10.5958/2231-5691.2020.00027.1