Formulation and Evaluation of

Laxative Oral Granules of Sterculia Gum

Presented by :
Ms. Kaveri Shivaji Aher.
M Pharm ( Sem II )Roll No. : 631

Department of Quality Assurance Technique.

Dr. D. Y. Patil Unitech Society’s
Dr.D.Y.Patil Institute of Pharmaceutical Sciences and Research,
Pimpri, Pune-18.
Guide : Co- Guide :
Dr. Sohan S. Chitlange. Dr. Harshad S. Kapare.
1
• Content :
o Introduction.
o Literature review : National & International Status
o Rational behind selection of topic & dosage form & formulation
o Aim & Objective
o Plan of work
o Methodology
o Mechanism of Action
o Anticipated outcomes
o Application/ Utilization of outcomes
o Collaboration/ Interdisciplinary relevance
o IPR value
o Translational Value
o References.
2
 STERCULIA GUM :
• Botanical Name : Sterculia gum,
Karaya Gum,
Indian Gum tragacanth.
• Source : Sterculia urens Roxb.
• Family : Sterculiaceae
• Species : Sterculia.
• Phytochemicals :

Robert introduces innovative Karaya gum ...

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Sterculia Gum
3
 Absorb 60
times its own
volume of
Contain NLT water
14% of Bulk Laxative
volatile acid
PROPERTIES
OF
STERCULIA
Sparingly
Creates GUM
soluble in
adhesive and water,
gelatinous Insoluble in
mass alcohol
Swell into
homogenous
4
 Magnesium • Antacid
Trisilicate • Osmotic Laxative

Magnesium • Osmotic Laxative

Citrate

• Anti-diarrheal
Heavy Kaolin • Adjunts to rehydration therapy

5
• National & International Status :
Sr. Title, Journal & year Author Conclusion
No.
1. Karaya Gum: General topic & Gabriel A.Lujan- Karya gum is native of India. it is producer
application. Medina, and exporter from India. according to Food &
Macromolecules An Indian Janeth Ventura, Agriculture Organization recognized as a food
Journal Ana Claudia Lara additive with the number E-416. Used as a
Year : 2013 Ceniceros, Granular or powder in food and
pharmaceutical formulation.
2. Medical management of fecal Yolanda Scarlett Sodium phosphate, magnesium sulfate,
incontinence. magnesium citrate are effective antidiarrheal
Gastroenterology showing mechanism, is believed to be
Year : 2004 decreased intestinal motility and stool
frequency resulting in more formed stools.
Increases in anal canal resting pressure.
3. Evidence for the safety of D. M. W. Gum Karaya (GK), accepted as Generally
gum Anderson Recognized as Safe (GRAS) in the USA since
karaya (Sterculia spp.) as a 1961, was accepted temporarily (Annex II) as
food additive a food additive by the EEC in 1974. Since
then no adverse incident involving human
Food Additives &
health has been attributed to the ingestion of
Contamination. GK.
Year : 2009

6
Sr. Title, Journal & Year Author Conclusion
No.
4. Viscosity, Swelling Index Aparanji Poosarla, According to viscosity, swelling index &
and Moisture Content in R. Muralikrishna moisture content study on sterculia gum
Gum Karaya. stated that Gum sterculia can be used as a
International Journal of good candidate for oral drug delivery as well
Science and Research as oral floating drug delivery with having
(IJSR) favourable biological properties such as non-
Year : 2015 toxicity, biocompatibility& biodegradability.

5 Bulking agents as laxatives Meier, P. ; Daily consumption of bulk laxative is

in geriatric patients. Seiler, W. O. ; significantly more efficient that periodic
Swiss medical weekly Stähelin, H. B. administration of bulk forming agent show at
Journal (Schweizerische the same level of effectiveness.
Medizinische
Wochenschrift)
Year : 1990

6. Magnesium trisilicate N. N. Manfred Kraemer The neutralizing power of magnesium

R. its position among trisilicate in treatment of peptic ulcer.
antacids used to treat peptic
ulcer
The American Journal of
Digestive Diseases
7Year : 1941
• Rational behind selection of topic :
1. Acid reflux due to constipation is
common condition.
2. During fasting, water content in the
Fig. 1.
Link Between Constipation and Acid Reflux
body decreases and epainassist.com

create irritation in stomach

and develop acidic condition. Fig.2 Intermittent Fasting - Types, Benefits ...
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3. To avoid heat stroke.

4. To get relief from excess water loss
during diarrhea condition.
5. Most of the country Area where,
water percentage is less.

10 countries with lowest access to water

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Fig.3 8
* To reduce moisture content * Neutraceutical.
* Hard * Novel Combination.
* Very difficult to transfer in * Different therapeutic
powder form effect.
*Manufacturing technology Product
* Dosage form development
* Natural product
* Safe and cost effective
New Formulation
* Patient Compliance
development
* Improved efficacy.
* Product development

9
 AIM
To formulate a Laxative oral granules of Sterculia gum.
OBJECTIVE
 To develop laxative oral granule dosage form with multiple applications as :
 Bulk laxative
 Demulcent
 Water retention agent
 Diarrhea controller
 Appetite control in the management of obesity.
 To characterize developed formulation at various evaluation parameter.
 To develop manufacturing technology in compliance with quality aspects,
regulations and manufacturing science and technology.
 Product development and scale up.
 Packaging Development
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 Literature Survey

Innovator Product Analysis ( Evacol & Normacol )

11
 • Plan of Work

• Ash.
Herbal drug analysis as • Acid insoluble ash.
per BP specification. : • Volatile Acid
• Microbial contamination.

Preformulation
study as per BP • Characteristic property.
/USP/ In house • Loss on Drying.
specification. • Loss on Ignition.
( Raw and API • Infrared absorption spectroscopy.
analysis )

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Preformulation • Microbial contamination.
study • Compatibility Study.

Design and development of formulation.

• pH
• Total ash
Finished product • Volatile acid
analysis.: • Microbial contamination
• Assay & stability study

Selection of suitable Packaging material and their

evaluation.
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14
• Drug / Active Pharmaceutical Ingredient :

Sr.No. Drug / API Role

1. Sterculia Gum Laxative.
2. Magnesium Antacid, Gastroesophagal
Trisilicate reflux.
3. Magnesium Osmotic laxative.
Citrate
4. Heavy Kaolin Adsorbent, Anti-diarrheal.

15
• Excipients :
Sr.No. Excipients Role
1. Talc Lubricant
2. Sucrose Sweetener
3. Arabic Gum Coating agent.
( Acacia Gum)
4. Chorophyllin Cupric Chelating agent
5. Vanillin Flavoring Agent
6. Sunset Yellow color Colouring Agent.

16
• Manufacturing Process :

Part I : Preparation of dry sterculia granules.

Sterculia Transfer to Sieve Transfer to Pass

Gum. FBD Granules FBD through
70 degree from #12/ 70 degree vibratory
Celsius 16 Celsius shifter of
12 #
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Part II : Part III: Part IV: Coating Part V:
Preparation of Preparation of of granules Lubrication of
coating powder. coating solution by 11 cycles Granules

Coating solution
Octagonal Reactor :
Blender or any a) Sucrose solution
blender : b) Arabic gum
solution
Magnesium c) a+b Neo Coater Blender at
d) Chlorphyllin
trisilicate + 5 rpm
cupric solution
Magnesium citrate e) Vanillin + ethanol
+ Heavy Kaolin + f) Sunset Yellow
50% of Talc color solution
g) c+d+e+f 18
 • Technology Transfer

Bench • Batch of 1 Kg as per

scale instrument capacity.

• Batch capacity of 120 Kg as

Pilot per instrument capacity, with 3
scale batches.

• Batch capacity
Commercial 240Kg to 480Kg as
Scale per instrument
capacity, with 7
batches.
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• Mechanism of action of formulation :
Dose : Adult: 3 to 5 spoonful granules swallow without chewing with
glass of water.
Children : One half of the above.

Youtube.com laxative
Fig. 6 20
• Anticipated Outcomes :
 The change in pH in intestinal region.

 Reduce the acidity.

 Soften the stool during constipation problem.

 Show the Soothing property to relive sore throat.

( Demulcent )

 Retain water in the body for longer period.

 Reduce dehydration process in the body.

 Absorb large volume of water during diarrhoea condition.

 Help to increase appetite and digestion process.

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• Application & Utilization of outcomes:

 Used as a Bulk Laxative in Constipation.

 Used as Demulcent.

 Used as Dietary supplement in fasting.

 Used as appetite inducer.

 Used in Diarrhoea.

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• Collaboration/ Interdisciplinary relevance :
 Department of Pharmaceutics
Formulation and Development process.

 SKY Biotech Life Sciences Pvt. Ltd., Gevari Tanda,

Aurangabad-431001.
Technical and Manufacturing support.

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 IPR VALUE
The developed technology can be patented.
Suitable formulation will be developed and research can
be published in indexed International peer reviewed
journal.

TRANSLATIONAL VALUE
Work can be further extended for process
optimization, and Invivo study for
pharmacological activity to develop a dosage
form of improved bio-pharmaceutical aspects.

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• References :
• Kraemer M. Magnesium trisilicate NNR Its position among antacids used
to treat peptic ulcer. The American Journal of Digestive Diseases. 1941
Feb 1;8(2):56.
• Meier P, Seiler WO, Stähelin HB. Bulking agents as laxatives in geriatric
patients. Schweizerische Medizinische Wochenschrift. 1990;120(9):314-7.
• Poosarla A, Muralikrishna R. Viscosity, swelling index and moisture
content in gum karaya. International Journal of Science and Research
(IJSR). 2015;6(4):1189-92.
• Anderson DM. Evidence for the safety of gum karaya (Sterculia spp.) as a
food additive. Food Additives & Contaminants. 1989 Apr 1;6(2):189-99.
• Norton C, Whitehead WE, Bliss DZ, Harari D, Lang J. Management of
fecal incontinence in adults. Neurourology and Urodynamics: Official
Journal of the International Continence Society. 2010 Jan;29(1):199-206.

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 Lujan-Medina GA, Ventura J, Ceniceros AC, Ascacio JA, Valdés DB,
Aguilar CN. Karaya gum: general topics and applications.
Macromolecules Indian J. 2013;9:111-6.
 WHISTLER RL. Exudate gums. Industrial gums 1993 Jan 1 (pp. 309-
339). Academic Press.
 Nayak AK, Hasnain MS. Sterculia gum based multiple units for oral
drug delivery. InPlant Polysaccharides-Based Multiple-Unit Systems for
Oral Drug Delivery 2019 (pp. 67-82). Springer, Singapore.
 Verbeken D, Dierckx S, Dewettinck K. Exudate gums: occurrence,
production, and applications. Applied microbiology and biotechnology.
2003 Nov 1;63(1):10-21.
 Cirillo C, Capasso R. Constipation and botanical medicines: an
overview. Phytotherapy Research. 2015 Oct;29(10):1488-93.
 Wald A. Constipation: advances in diagnosis and treatment. Jama. 2016
Jan 12;315(2):185-91.

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