Ranitidine floating tablet in ulcer healing and Smoothing by Nitish Nirala

1. “RANITIDINE FLOATING TABLET IN ULCER HEALING AND SOOTHING”
PROJECT REPORT SUBMITTED TO
ARYABHATTA KNOWLEDGE UNIVERSITY, PATNA
In partial fulfillment of the award of the degree of
BACHELOR OF PHARMACY
GOVERNMENT PHARMACY INSTITUTE AGAMKUAN, PATNA -07.
NITISH NIRALA
Reg. No: -19109112039
Session: - 2019-2023
Dr. Ram Kumar Choudhary, M.Pharm., Ph.D.
Under the esteemed guidance of
Principal

2. ABSTRACT
In this current work, floating tablets of ranitidine and aloe vera were prepared. The objective
behind the work was to develop a formulation of an H2 antagonist in collaboration with aloe vera
to produce an ulcer-soothing and ulcer-protective effect. Ranitidine is a histamine H2-receptor
antagonist. It is widely prescribed for active duodenal ulcers, gastric ulcers, Zollinger-Ellison
syndrome, gastroesophageal reflux disease, and erosive esophagitis. The effective treatment of
erosive esophagitis requires the administration of 150 mg of Ranitidine four times a day. A
conventional dose of 150 mg can inhibit gastric acid, whereas aloe vera will produce an ulcer-
soothing effect and a laxative effect. In-vitro buoyancy studies were performed for all ten
formulations as per the method described by Rosa et al. As per USP, the randomly selected
tablets from each formulation were kept in a 100ml beaker containing simulated gastric fluid, pH
1.2. The time taken for the tablet to rise to the surface and float was taken as floating lag time
(FLT).

3. INTRODUCTION
Tablets are commonly used dosage forms for convenience and ease of manufacturing. However,
oral administration is limited for essential drugs due to poor oral bioavailability due to
incomplete absorption or degradation in the gastrointestinal tract. Gastro Retentive Drug
Delivery Systems (GRDDS) can be developed to increase the gastric retention time of drugs,
reducing drug waste and improving solubility in the small intestine's high pH environment. The
most effective strategy to improve drug absorption is to retain the formulation in the stomach.
Ranitidine hydrochloride, a histamine H2-receptor antagonist, is widely prescribed for active
duodenal ulcers, gastric ulcers, Zollinger-Ellison syndrome, gastroesophageal reflux disease, and
erosive esophagitis. A sustained-release dosage form of Ranitidine hydrochloride is desirable due
to its short biological half-life and poor bioavailability from the colon. Aloe Vera, a laxative, is
added to the formulation to provide a soothing effect on ulcers.

4. CAUSE OF PEPTIC ULCER

5. TYPES PEPTIC ULCER
 Peptic ulcers are painful
sores on the stomach,
small intestine, or
esophagus caused by
damaged digestive tract
lining, allowing stomach
acid to contact
underlying tissue.

6.  DRY GRANULATION
 WET GRANULATION
 DIRECT GRANULATION
METHODS OF GRANULATION
Fig.: Flow Chat Of Granulation

7. EVALUATION OF TABLETS
Hardness
Friability
Drug content uniformity
Weight variation test
Wetting time
Water absorption ratio
Thickness of Tablets
In vitro dispersion time
In vitro disintegration test
In-vitro buoyancy studies

8. GASTRO RETENTIVE DRUG DELIVERY SYSTEM
The Gastro Retentive Drug Delivery System (GRDDS) is a pharmaceutical advancement
technology that uses gastric retention to deliver drugs with narrow absorption windows
in the small intestine. With low-density buoyancy, this innovative floating drug delivery
system allows for prolonged drug action and better control of plasma drug
concentrations, minimizing mucosal irritation.
The floating dosage form is suitable for drug delivery in the following contexts:
 Locally active in the stomach.
 Drugs with a narrow absorption window in the stomach or the upper small intestine.
 Drugs that disturb colonic bacteria.
 Longer residence time in the stomach is highly desirable for drugs.
 Drugs with low solubility at high pH value.
 High variability in gastric emptying time.

9. FLOATING DRUG DELIVERY
Floating drug delivery,
first described in 1968
by Davis, is a technique
for achieving gastric
retention by keeping
the system buoyant in
the stomach and
releasing the drug
slowly, allowing better
control over plasma
drug concentration
fluctuations.

10. CLASSIFICATION OF FLOATING SYSTEM
A. Non-effervescent systems:
 Colloidal gel barrier system
 Bilayer floating tablets
 Microporous compartment system
 Hollow microspheres
 Alginate beads
B. Effervescent systems:
 Volatile liquid-containing system
 Gas-generating system

11. FACTORS AFFECTING GASTRIC RETENTION
 The gastric emptying rate depends mainly on the viscosity, volume, and
caloric content of meals.
 Increase in acidity and caloric value slows down gastric emptying time.
 Biological factors such as age, body mass index (BMI), gender, posture, and
diseased states (diabetes, Chron’s disease) influence gastric emptying.
 In the case of elderly persons, gastric emptying is slowed down.
 Generally, females have slower gastric emptying rates than males.
 Stress increases gastric emptying rates while depression slows it down.

12. RANITIDINE
 Ranitidine is a medication
primarily used to reduce stomach
acid production.
 Indications:
a.Treatment of ulcers (peptic, gastric,
duodenal)
b.Gastroesophageal reflux disease
(GERD)
c.Zollinger-Ellison syndrome (a rare
condition causing excess stomach
acid)
Mechanism of Action:
It's an H2 receptor antagonist that
inhibits histamine action on stomach
acid production.

13. ALOE VERA
 Aloe vera is a succulent plant known for
its medicinal and cosmetic properties.
 Aloe vera contains 75 potentially active
constituents: vitamins, enzymes,
Minerals, sugars, lignin, saponins,
salicylic, and amino acids
MECHANISM OF ACTION OF ALOE VERA:
 Healing properties
 Anti-inflammatory action
 Effects on the immune system
 Moisturizing and anti-aging effects

14. GASTRIC ULCER
A gastric ulcer, a stomach or
peptic ulcer, is a sore or open
wound that develops in the
stomach lining. These ulcers
can range in size and depth
and typically result from a
breakdown in the stomach’s
protective lining, allowing
stomach acid to damage the
underlying tissue.

16. MATERIALS AND METHODOLOGY

17. EVALUATION
 Weight Variation
 Thickness of Tablets
 Friability
 Hardness
 Disintegration Time

18. IN VITRO DRUG RELEASE STUDY
Fig.: In-Vitro Drug Dissolution Profile

19. FIG.: In-Vitro Dissolution Profile of the finalized formulation(B2)

20. CONCLUSION
The experiment involved creating five different formulations of Ranitidine
floating tablets, with HPMC & PVP showing good batch-to-batch
reproducibility. The optimized formulation, B2, was found to deliver
Ranitidine following GI administration. These tablets could be used for
instant, delayed, and sustained drug release for ulcer treatment, reducing
dosing frequency, minimizing drug loss, and increasing efficacy and patient
compliance.

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