GUIDED BY:

Dr. M. R. PATEL

PRESENTEDE BY:

NITINKUMAR S. PARMARM. PHARM – I (2013-14)ROLL NO. - 06

DEPARTMENT OF PHARMACEUTICSSHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND REASERCH, MODASA-2013

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

Contents

IntroductionAdvantages of semisolid dosage formClassification Plant layout

Qualitative Plant Layout for semisolid Quantitative Plant Layout for semisolid

Plant layout for manufacturing of suppositoryReferences

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

INTRODUCTION

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

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.

DEFINITION

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

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

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 Preparations1. 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 Suppositories1. 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

Waxmeltingmixing

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

25 Lts. to 10000 Lts. (2000 L)

Plant area:Raw material storage area: 18.5sq. mt.

Manufacturing area: 40.8 sq. mt.

Filling area:27 sq. mt. Packing & Labeling area:46.8 sq. mt. Final product storage area:14 sq. mt.

oilyAq.mixer

Tube filling machine

(500 KG)

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 Kg3. Oily phase(75%): 170 kg4. 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

General Corridor

entry

Male change room

Female change room

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API’s

storage

Raw material storage

Suppositories and pessaries manufacturing

area

QC

Steam generator

for heating

Storage of various moulds

Vessels stores

Storage of containers

Freezing area

Corridor

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Off

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Plant layout for manufacturing of suppository

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 IP6. 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.com5. www.kotharipharma.com6. www.riddhipharma.com7. www.keimachines.com8. www.vabatrading.nl9. www.packexpo.com10.www.in-pharmatechnology.com

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

Thank You

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