PRESENTEDE BY:

GUIDED BY: NITINKUMAR S. PARMAR

M. PHARM – I (2013-14)
ROLL NO. - 06
Dr. M. R. PATEL DEPARTMENT OF PHARMACEUTICS
SHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND REASERCH, MODASA-2013
SHRI B.M.C.P.E.R, MODASA
 Contents
Introduction
Advantages of semisolid dosage form
Classification
Plant layout
Qualitative Plant Layout for semisolid


 Quantitative Plant Layout for semisolid

Plant layout for manufacturing of suppository

References

SHRI B.M.C.P.E.R, MODASA

 INTRODUCTION

 Semisolid pharmaceutical systems comprise a body of products, which

when applied to the skin or accessible mucous membranes tend to
alleviate or treat a pathological condition or offer protection against a
harmful environment.
 They have the property to cling to the skin or mucous membrane for a
protracted period of time to exert their therapeutic effect through
protection and occlusion. The adhesion is due to their plastic rheological
behavior which allows semisolid to retain their shape and cling as film
until acted upon by an outside force.
 Semisolid dosage forms usually are intended for localized drug delivery. In
the past few years, however, these forms also have been explored for the
systemic delivery of various drugs. Semisolids constitute a significant
proportion of pharmaceutical dosage forms. They can be applied topically
to the skin, cornea, rectal tissue, nasal mucosa, vagina, buccaltissue,
urethral membrane, and external ear lining.
SHRI B.M.C.P.E.R, MODASA
 DEFINITION
 Semisolid dosage forms are dermatological products of semisolid
consistency and applied to skin for therapeutic or protective
action or cosmetic function.
Advantages of semisolid dosage form
 Avoidance of first pass metabolism
 Avoidance of gastro intestinal incompatibility
 Predictable and extended duration of activity
 Delivery via the skin route is an interesting option because route is
convenient and safe
 Provide suitability for self administration
 Enhance therapeutic efficacy of drugs
 Avoiding the fluctuation in drug levels
 Inter and intra patient variations
 Maintain plasma concentration of potent drugs
 Termination of therapy is easy at any point of time
SHRI B.M.C.P.E.R, MODASA
 Classification

SHRI B.M.C.P.E.R, MODASA

 Semisolid dosage forms intended for topical
application

SHRI B.M.C.P.E.R, MODASA

 Plant layout

Requirements of plant as per schedule M

External Preparations
1. A minimum area of 30 square meters for basic
installation of 10 square meters for Ancillary area
is recommended.
2. Areas for formulations meant for external use and
internal use shall be separately provided to avoid
mix-up.

Pessaries and Suppositories

1. A minimum area of 20 square meters is
recommended to allow for the basic installation.
2. In the case of Pessaries manufactured by
granulation and compression.
SHRI B.M.C.P.E.R, MODASA
 Qualitative Plant Layout for semisolid
IPQC

Wax
mixing melting

SHRI B.M.C.P.E.R, MODASA

Ointment/Cream manufacturing & Processing plant

SHRI B.M.C.P.E.R, MODASA

 Quantitative Layout for cream
Plant area:
25 Lts.
Raw material to 10000
storage area: Lts. (2000 L)

18.5sq. mt.

Manufacturing area:
40.8 sq. mt.
Tube filling machine
Filling area:27 sq.
mt.

Packing & Labeling mixer

Aq. (500 KG) oily
area:46.8 sq. mt.

Final product
storage area:14 sq.
mt.

SHRI B.M.C.P.E.R, MODASA

 Quantitative Layout
• Plant Capacity: 10,000 Tubes/Day

• Raw Material Quantity:

1. For preparing: 10000 Tubes (20 gm each)
2. Total mass needed: about 225 Kg
3. Oily phase(75%): 170 kg
4. Aq. phase + Drug(25%): 55 kg
• Capacity of equipment:
• Mixing capacity of mixer 100 kg /shift
• Tube filling machine output 60/80 tubes pm.
• 3600 tubes per hr.(3 hr.)

SHRI B.M.C.P.E.R, MODASA

 Plant layout for manufacturing of suppository

Raw material
API’s Storage of various Steam

entry
IPQC moulds generator
storage

Melting area
QC
for
heating

Raw Suppositories

Weighing
material and pessaries Freezing
Male storage manufacturing area
e chang
Corridor area
n e room
t
r Corridor
y

Corrugated box packing

Female
change
Vessels

machine
room

Packing
corrugated box

IPQC for packed

line packing in
stores

Quarantine area
Storage of
product

suppositories
despatch

Office

Storage
of
container
General Corridor
s

SHRI B.M.C.P.E.R, MODASA

 Specific requirement for
manufacturing of topical preparation
1. Manufacturing area under suitable AIR LOCK.
Outside air lock INSECTOCUTORS shall be installed.
2. The air to this manufacturing area shall be filtered
through at least 20μ air filters and shall be air-
conditioned.
3. An EXHAUST SYSTEM of suitable capacity.
4. NO RAGS OR DUSTERS shall be used in process of
cleaning & drying.
5. Water used in compounding shall be PURIFIED
WATER IP
6. Powders SUITABLY SIEVED, before use.
7. Heating vehicles & base like petroleum jelly shall be
done in SEPARATE MIXING AREA.
8. The temperature of manufacturing area shall NOT
EXCEED 30˚C.

SHRI B.M.C.P.E.R, MODASA

 References
1. Drug and Cosmetic act, 1940 page no. 432 -434.
2. Pharmaceutical Dosage forms: Disperse System
Vol: 3 Edited
3. Herbert A. Lieberman, Martin M.Rieger, Gilbert
S. Banker
4. www.wintechpharmachem.com
5. www.kotharipharma.com
6. www.riddhipharma.com
7. www.keimachines.com
8. www.vabatrading.nl
9. www.packexpo.com
10. www.in-pharmatechnology.com

SHRI B.M.C.P.E.R, MODASA

 Thank You

SHRI B.M.C.P.E.R, MODASA