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Tablets

Topical preparations
are used in treatment
of :

• Cellulitis
ANTIBACTERIAL Capsules • Impetigo
• Boils
• Leprosy
(Minnesota Departmen of Health, 2017)

Topical
preparations
https/www.wjen.com
Stability testing is an important part of the drug development and
approval process, determining the safety and integrity of the drug and
also the shelf life and storage conditions (Price, 2017).
General objective
◦ The study aims to perform a stability testing on the formulated
topical antibacterial cream from the ethanolic leaf extracts of C.
dichotoma.

Specific objectives
To test the stability of the formulated cream under the parameters of:
1. Temperature variation
2. Light exposure
3. Relative humidity
To observe physical characteristics before and after stability testing of
formulated cream in terms of:
1. Color
2. Odor
3. Texture
4. Appearance
5. pH
6. Spreadability
7. Homogeneity

To evaluate the percent inhibition property of the formulated Cordia


dichotoma cream against Staphylococcus aureus, Pseudomonas
aeruginosa, Staphylococcus epidermidis & Escherichia coli.
The study will be beneficial the following:

 Patients with bacterial skin infections

 Department of Health

 Manufacturing firms

 Dermatologists

 Future researchers
The researchers will test the following:
 The flavonoid constituent of C. dichotoma leaf extracts.

 Physicochemical properties of the cream such as;


Color, Odor, Homogeneity, Spreadability and pH.

 Physical stability of the cream


Temperature variation, relative humidity and light exposure.

 Microbial assay of the crude extract and the cream against:

Staphylococcus aureus, Staphylococcus epidermidis


Pseudomonas aeruginosa, Escherichia coli
Kingdom • Plantae

Subkingdom • Tracheobionta

Superdivision: • Spermatophyta

Division • Magnoliophyta

Class • Magnoliopsida

Order • Lamiales

Family • Boraginaceae

Genus • Cordia L.

Species: • Cordia dichotoma G. Forst.

(US Department of Agriculture, 2017)


Language Common name
English Indian cherry
Soap berry
Fragrant marijack
Indonesia Nunang
Toteolo
Kendal
Chinese Feng zhengzi
Malaysia Petekat
Sekendal

Anonang Saloyong
Filipino Anono Bibili
Anong Sinaligan
According to d’Aillon (2016) Boraginaceae have about 150 genera and about
2000 species. Having hairy stems and leaves, absence of stipules and four
seeds. They can also be annuals or perennials.

(Jamkhande, et al., 2013)


Geographical Distribution

C. dichotoma is most common in


the tropics and subtropical
regions.
C. dichotoma is distributed partly
in the Philippines. It is also
widespread throughout Southern
China and other countries like
Malaysia to tropical Australia
(Jamkhande, et al, 2013).
WOOD LEAVES FRUIT FLOWER
Wrappings for cooking of fish As food
For construction Protection against heat waves

Cigarette wrappers Use to startle fishes


As tool handle

Fodders
For furniture making

SEED KERNELS BRANCHES BARK


For Cattle feed Termite detterent
Made into rope

(Jamkhande, et al., 2013) (Orwa, et al., 2009)


BARK LEAVES FRUITS SEEDS
• For headache • Antimigraine • Demulcent • Remedy for
• Diarrhea • For inflammation • Laxative ringworm
• Stomach ache • Anti infertility • Cough infection
• Tonic preparation • Anti inflammatory
• Mild astringent • Anthelmintic
• Strengthen teeth • Wound healting

(Fern, 2018) (Jamkhande, et al., 2013).


Antimicrobial/Antibacterial studies of C.dichotoma
Author/s, Year Title Findings
Gupta, et al., 2016 Antibacterial activity and Photocatalytic C. dichotoma leaf extracts in various AgNP’s
degradation efficacy of silver nanoparticles concentration inhibits P. aeruginosa and E. coli
biosynthesized (AgNP’s) using Cordia with zone of inhibition of 10 mm and 12 mm
dichotoma leaf extracts. respectively and noted to be a concentration
dependent.
Konka, et al., 2014 Cordia dichotoma crude extracts: potent The leaf extracts of C. dichotoma inhibits S.
source of natural antibacterial and antioxidants aureus, P. aeruginosa, B. subtilis, B. cereus, P.
agents vulgaris with zone of inhibition of 10 mm, 9 mm
,11 mm, 6 mm, 7 mm and 5 mm in the
concentration of 150 μg/ml which is also a good
source of antioxidant.
Patel and Rao, 2011 Antibacterial activity of C. dichotoma during its The antibacterial potential of C. dichotoma
growth and ripening of fruit methanolic fruit extract inhibited Salmonella
paratyphi in 0.5 mg/ml concentration.
Author/s Title Findings
Rahman, Sahabjada, et al., Anticancer activity of Cordia dichotoma leaves The 160 mg of alcoholic leaf extracts of C.
2016 against a human prostate carcinoma cell line. dichotoma possesses anticancer activity and
leads to PC3 cell death via induction of
apoptosis mediated through excessive ROS
generation.
Saha & Bhattacharya, 2013 Evaluation contraceptive action of Cordia C. dichotoma leaf extracts shows contraceptive
dichotoma leaves extrac action on female albino rats in the dose
concentration of 250 mg/kg.
Nariya, et al., 2013 Evaluation of antioxidant property of Cordia Determined the antioxidant action of butanol
dichotoma bark and methanol bark extract of C. dichotoma by
free radical scavenging assay and revealed that
the C. dichotoma bark has antioxidant activity.
Gupta, R., & Kaur, J. 2015 Evaluation of analgesic, antipyretic and anti- The 400mg/kg concentration of methanolic
inflammatory activity on Cordia dichotoma leaf extracts was used in various methods in
the evaluation of analgesic, antipyretic and
anti-inflammatory to the female rats and
compares to the standard drug. The result of
each action was presented in graph which
concludes that as highly effective as analgesic,
Author/s, Year Title Findings
Barde, et al., 2015 A Plant profile, phytochemistry and The presence of pyrrolizidine
pharmacology of Cordia dichotoma coumarins, flavonoids, terpenes and
sterols was confirmed.
Hussain and Rhaman, 2015 Analytical evaluation and The presence of steroid, flavonoid
phytochemistry of Cordia dichotoma and phenolic compounds showed in
Leaves methanolic extracts.

Akhtar and Rhaan , 2013 Phytochemistry of Cordia dichotoma Alkaloid, flavonoid, triterpenoid,
(Boraginaceae) glycoside, protein, amino acid and
carbohydrate was found.
Bacterial Strains
The inhibitory antibacterial action of the crude leaf extracts
as well as the formulated cream will be tested against to the
following bacteria. Most of the strains are chosen according
to the skin susceptibility of infection.
S. aureus S. epidermidis P. aeruginosa E. Coli
• Gram negative • Gram negative
• Gram positive • Gram positive
• Causing severe • Causing Traveler’s
• Causing Infective • Causing hospital
wounds and diarrhea, urinary
endocarditis, skin acquired
urinary tract teact infection
and soft tissue infection(Atlas of Oral
(Tong, et al., 2015). Microbiology, 2015). infection (Prince (2012), and pneumonia
(Davis & Anand, 2018).
Procedure for extraction
Collection of Cordia dichotoma Forst. Evaporation & Concentration
leaves

Drying & Grinding Collection of extracts

Exhaustive Percolation
Ingredients Uses
OIL PHASE
Stearic acid Thickening agent
Glycerin Humectant
Cetyl alcohol Emulsifier
WATER PHASE
Potassium Hydroxide Emulsifier
Methyl Paraben Preservative
Propyl Paraben Preservative
Cordia dichotoma Forst. Active Ingredient
leaf extracts
Almond oil Fragrant
Purified water Vehicle
SHINODA TEST (Nandedkar & Mulani, 2016)
5g of concentrated leaf extracts

Add 10 drops of diluted HCl

Mix a small piece of


magnesium in sol’n

Formation of reddish brown


or pink color
Microbiological assay
Organism culture
(Mueller Hinton Broth)

Adjust the turbidity of the


inoculum using normal saline

Streak twice on
Mueller- Hinton agar

Saturate sterile filter


Positive Control: paper disk with sample

Chloramphenicol Incubate at 37°C

Observe zone of inhibition after 24 hours


Preparation of water Mixture of the two
phase phase
Ethanolic Leaf extract Preparation of oil Aqueous phase + Oil phase at
70°C
+ phase
Potassium Hydroxide
Cetyl alchohol
+
+ Addition of Almond Oil
Methyl paraben
Glycerine
+
+
Propyl paraben
Stearic acid
Formulated
cream

Heated at 70°C Melted at 70°C


Color Color Mate Visual
Homogeneity
Application Inspection

(Saad, etal., 2013)

Glass plate,
Physical
Odor Spreadabilty Glass scale
Inspection
plate

(Garg, etal., 2002)

pH pH meter

(Sawant & Tajane, 2016)


Temperature variation
Light exposure
Relative Humidity

•STABILITY CABINET •WHITE FLUORESCENT


• 8°C, 25°C, 40°C + 75% RH

International Council for Harmonisation, 2013


Rasul, et al., (2011) and Deivi (2013),
 All methods will be performed in triplicates. For the microbial
assay the result will be evaluated using one- factor analysis of
variance (ANOVA).

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