This document summarizes the manufacturing process of Zestril 10 mg tablets. It describes the ingredients in each tablet, including the active ingredient Lisinopril dihydrate. It then outlines the manufacturing process which involves mixing, milling, granulating, drying, blending, and compressing the ingredients. The document also provides information on the indications, therapeutic class, pharmacology, contraindications, side effects, and storage requirements of Zestril tablets.

1. PHARMACY PRACTICE IN RESEARCH AND
DEVELOPMENT
Presented By:
All An Shariah Brishti
Sec:13th (B)
Daffodil International
University

2.  Crucial to survival
 Fast changing environment
 Continuous technology change
 To the development of new products
 Changing consumer preferences
 To improvement of existing products or procedures
 Understanding what markets need (MR)
 Efficient production processes
Importance of R&D

3. SL. NO. Ingredients Used As Mg/Tablet Mg/Batch Tablet
1 Lisinopril dihydrate Active Ingredient 10.00 10,000
2 mannitol Sweeting agent 3.00 3000
3 Calcium hydrogen
phosphate dihydrate
Diluent 26.75 26,750
4 Maize starch Disintegrant 6.00 6000
5 Pregelatinised starch Binder 3.5 3,500
6 Magnesium stearate Lubricants 0.5 500
7 Colloidal anhydrous silica Glidants 0.25 250
Formulation:

4. Pregelatinised starch solution
added to the powder to make mass
Screening of the wet mass
Drying of the wet granules
Screening of dry granules
Blending with lubricant , glidant
and Disintegrant.
Compression of table
Calcium hydrogen phosphate dihydrate
and Lisinopril dihydrate taken in a bowl
and mixed properly
At first dispense all the ingredient
Then sizing and milling of API and
excipient
Packing of tablet
Manufacturing process

5. ZESTRIL10 MG TABLET:
Each Zestril tablet contain the active
substance is lisinopril dihydrate10 mg and
other ingredients are mannitol 3mg,
calcium hydrogen phosphate dihydrate
26.75mg,
maize starch 6mg, pregelatinised starch
3.5mg,
Magnesium stearate 0.5mg and
colloidal anhydrous silica 0.25mg. Batch no: UR 2017
Mfg.Date:Oct.17
Exp.Date:Sep.19
MRP Tk.160.00

6.  Acute heart failure,
 Coronary artery disease,
 Diabetic nephropathy,
 Heart failure,
 Hypertension,
 Myocardial infarction
 Angiotensin-converting enzyme (ACE)
inhibitors
Indication:
Therapeutic class:

7. Pharmacology:
Angiotensinogen
Angiotensin I
ACE ACE inhibitors
(-)
Inhibition of Angiotensin II formation
Decrease aldosterone secretion and decrease
sodium & water retention
Decrease blood volume Decreased blood pressure

8. Zestril is contraindicated in
 pregnancy,
 Breast feeding women,
 low blood pressure,
 high dose diuretic therapy,
 salt depleted states,
 hypersensitivity to any component of Zestril.
CONTRAINDICATIONS:

9.  Headache,
 Fatigue,
 Chest and abdominal pain,
 Dizziness,
 Nausea,
 Vomiting,
 Upper respiratory tract infection,
 Hypotension,
Side effect:

10.  Do not store above 30°C .
 Keep out of the reach of children.
 Protect from moisture and excessive
heat.
 Do not keep outdated medicine or
medicine no longer needed.
Storage:

11. Tablet requires a certain amount of strength or hardness and resistance to
withstand mechanical shocks of handling in manufacture, packaging and
shipping.
 Compression of the tablet and compressive force.
 Amount of binder. (More binder à more hardness)
 Method of granulation in preparing the tablet (wet method
gives more hardness than direct method, Slugging method
gives the best hardness).
Hardness :
Factors Affectingthe Hardness:

12.  Design and construct the facilities and equipment's properly
 Follow written procedures and Instructions
 Document work
 Validate work
 Monitor facilities and equipment
 Write step by step operating procedures and work on instructions
 Design ,develop and demonstrate job competence
 Protect against contamination
 Control components and product related processes
 Conduct planned and periodic audits
Principles of GMP