Ranitidine

1. INTRODUCTION

Ranitidine is is a prescription drug used to treat ulcers, gastroesophageal

reflux disease (GERD), a condition in which backward flow of acid from the
stomach causes heartburn and injury of the food pipe (esophagus), and
conditions where the stomach produces too much acid, for example Zollinger-
Ellison syndrome. Ranitidine is in a class of medications called H2 blockers.
Ranitidine works by decreasing the amount of acid made by the stomach.
This helps reduce pain and also allows an ulcer and/or reflux disease to heal
in most people.

Ranitidine mainly comes as tablets, soluble (dispersible) tablets that dissolve

in water to make a drink, or as a liquid that you drink.

2. SYNONYMS AND TRADE NAME

Synonyms available for Ranitidine as below:

 AH 19065
 AH-19065
 AH19065
 Biotidin
 Hydrochloride, Ranitidine
 N (2-(((5-((Dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-N'-methyl-2-
nitro-1,1-ethenediamine
 Ranisen
 Ranitidin
 Ranitidine
 Ranitidine Hydrochloride

3. CHEMICAL AND STRUCTURE

The molecular formula for Ranitidine is C13H22N4O3S, and molecular weight of

314.404 g/mol.

Figure 1: 2D Structure - Ranitidine

 Ranitidine

4. SOLUBILITY

Water Solubility at 24.7 mg/mL.

5. IDENTIFICATION

Through clinical laboratory method; A first order derivative spectroscopic

method was developed and used to study the kinetics of piroxicam and
ranitidine absorption from the gastrointestinal tract in rats.

The drug identification number (DIN) as below:

02336480 RAN-RANITIDINE 150MG TABLET
02336502 RAN-RANITIDINE 300MG TABLET

6. DOSAGE FORM

Randatine comes in the following forms:

No. Forms Strength

1 Injection Solutions 25mg/mL
2 Syrup 15mg/mL
3 Tablet 75mg
150mg
300mg
4 Capsule 150mg
300mg

7. DOSE

The recommended dosage for Ranitidine as below:

No. Treatment Dosage

1 Duodenal (intestinal) Adult:
ulcer Treatment of an active intestinal ulcer: 150 mg
taken twice per day or 300 mg taken once per
day. If you take one dose, take it after your
evening meal or at bedtime. Maintenance
therapy: 150 mg taken once per day at
bedtime.

Child:
Typical dosage: 2–4 mg/kg of body weight
twice per day. Maximum dosage: 300 mg per
day.
 Ranitidine

Senior:
Doctor may start on a lower dosage or a
different treatment schedule. This can help
keep levels of the drug from building up too
much in body.

2 Gastric (stomach) Adult:

ulcer Treatment of an active stomach ulcer: 150 mg
twice per day. For maintenance therapy: 150
mg once per day at bedtime.

Child:
Typical dosage: 2–4 mg/kg of body weight
twice per day. Maximum dosage: 300 mg per
day.

Senior:
Doctor may start on a lower dosage or a
different treatment schedule. This can help
keep levels of the drug from building up too
much in body.

3 Gastroesophageal Adult:
reflux disease Typical dosage: 150 mg taken twice per day.
(GERD)
Child:
Typical dosage: 5–10 mg/kg of body weight
per day in two divided doses.

Senior:
Doctor may start on a lower dosage or a
different treatment schedule. This can help
keep levels of the drug from building up too
much in body.

4 Erosive esophagitis Adult:

Treatment of active disease: 150 mg four
times per day. For maintenance therapy: 150
mg twice per day

Child:
Typical dosage: 5–10 mg/kg of body weight
per day in two divided doses.

Senior:
Doctor may start on a lower dosage or a
different treatment schedule. This can help
keep levels of the drug from building up too
much in body.
 Ranitidine

5 Hypersecretory Adult:
conditions Typical dosage: 150 mg twice per day.
Dosage increases: Doctor may change
dosage as needed. Maximum dosage: 6,000
mg (or 6 g) per day.

Child:
It hasn’t been confirmed that this drug is safe
and effective in people younger than 18 years
for this condition.

Senior:
If severe kidney disease is observed, doctor
may start with 150 mg once per day.

 Adult means at age of 17-64 years old

 Child means at age of 1month-16 years old
 Senior means at age 65 years old and above

8. PHARMALOGICAL

Ranitidine is a histamine H2-receptor antagonist similar to cimetidine and

famotidine. An H2-receptor antagonist, often shortened to H2 antagonist, is a
drug used to block the action of histamine on parietal cells in the stomach,
decreasing acid production by these cells. These drugs are used in the
treatment of dyspepsia, however their use has waned since the advent of the
more effective proton pump inhibitors. Like the H1-antihistamines, the H2
antagonists are inverse agonists rather than true receptor antagonists.

9. PRODUCT NAME

The product names available for Ranitidine are Zantac, Zantac 75, Zantac
150 Maximum Strength, Deprizine FusePaq, etc.
 Ranitidine

10. MATERIALS AND METHOD OF PREPARATION

Calculate the quantity of each ingredient for the amount to be prepared.

Accurately weigh or measure each ingredient. Mix the ranitidine hydrochloride
with a small quantity of syrup to form a smooth paste. Geometrically, add
additional syrup to final volume and mix well. Package and label.

11. EVALUATION AND QUALITY CONTROL

Quality-control assessment can include weight/volume, pH (6.7-7.5), specific

gravity, active drug assay, color, clarity, rheologic properties/pourability,
physical observation, and physical stability (discoloration, foreign materials,
gas formation, mold growth).

12. DESIGN AND PACKAGING

The packaging has to be in tight and light-resistant containers. The label shall
contain “ Keep out of reach of children, Keep refrigerated, Shake well and
Discard after ____ [time period].

Ranitidine prepared is stable from a beyond-use date of up to 153 days.

13. REFERENCES

1. Reinoso RI et al; Rev Farm Bioquim Univ Sao Paulo 27 (Jul-Dec): 113-
26 (1992)
2. https://pubchem.ncbi.nlm.nih.gov/compound/ranitidine#section=Use-
and-Manufacturing
3. https://reference.medscape.com/drug/zantac-ranitidine-342003
4. https://www.healthline.com/health/ranitidine-oral-tablet#dosage
5. http://www.drugbank.ca/drugs/DB00863https://www.uspharmacist.com/
article/ranitidine-hydrochloride-25-mg-ml-syrup-alcoholfree