Pharmaceutical Warehouse

INTRODUCTION:

Ware house is the place where the raw materials, packaging materials and finished products are received, stored and dispatched according to their requirement. Before dispatching, the materials and finished products need to be stored with in an accurately controlled storage environment cGMP validation requirement. This may be achieved by monitoring temperature and humidity sensors continuously

FUNCTION OF WARE HOUSE

1.          Storage of raw and packaging materials.
2.          Temporary storage of finished product before going to control deport storage of rejected materials before disposals.

ACTIVITIES OF WARE HOUSE:

1. Routine works.

2. Periodic works.

Routine works:

a)      Receiving the raw/packaging material and finished products.

b)      Storing these materials in appropriate conditions.

c)      Issuing the raw/packaging material for disposing.

d)      Dispatching finished product

e)      Cleaning the ware house.

Periodic works:

a)      Export of finished goods.

b)      When a new product is launched or product existing price is changed, then warehouse department inform customs department of the government.

DIVISIONS OF WARE HOUSE:

In Drug international Limited ware house is situated on the 1^st floor and ground floor.

They are divided into three categories:

1.      Raw Materials Store (R.M.S)

2.      Packaging materials Store (P.M.S)

3.      Finished product Store (F.P.S)

Raw Materials Store (R.M.S):

Any materials used in the packaging of a product. The term is not only normally extended to cover the outer packaging or delivery cases but also used to the transformation or shipment of the orders.

This is an area where raw materials (API and Excipients) are stored and supplied to the production area after permission of legal authority. In Drug international Limited there are three areas for raw material store:

Area-R1: For excipients e.g. Aerocil 200, Lactose, Sucrose

Area-R2: For API, area is divided for sensitive API e.g. Antibiotics

Area-R3: For API & Excipient of Liquid section e.g. glycerin

Packaging materials Store (P.M.S)

In this area various types of packaging materials are stored. These including:

1. Inners

2. Inserts

3. Shipping carton

4. Cap and spoon for oral liquid

There are four labeling machines in this area and more than 8 workers with an in-charge person

Finished product Store (F.P.S)

The products which are ready for market are known as finished products. This is a large area for storing finished products. The shipping carton of finished products is store in this area.

There are three storage conditions are generally maintained in the ware house-

1. Temperature 15-25°c. The total area for storing packaging materials, raw materials, finished products. The condition is maintained by HVAC system.
2. Temperature 8-15°c. This condition is used to store some raw materials refrigeration is used for this purpose.
3. Temperature 2-8°c.Some Antibiotics & active Pharmaceutical ingredients (API) are stored in this condition.

Pharmaceutical Packing

INTRODUCTION

Packaging can be defined as an economical means of providing presentation, protection, identification information, containment, convenience and compliance for a product during storage, carriage display and use until such time as the product is used or administered. After compression of tablets and coating (if required) the tablets are packed either in blister pack or in the strip.

Packaging area:

There are two types of packaging area:

◈    Primary packaging area

◈    Secondary packaging area

Primary packaging area:

Packaging of solid dosage form is of two types:

v  Stip packaging:

Striping materials are –

ü  Alu-Alu type

ü  PVC- Alu-PVC type

v  Blister packaging:

Blistering materials are-

ü  Alu-Alu type

ü  Alu-PVC type

ü  Alu-PVDC type

Steps of blister packaging:

EQUIPMENTS USED IN PACKAGING AREA:

BLISTER MACHIN – 01

Model: Ministar – V

Capacity: 35X4 =140 strip/min

Max rpm – 38

Set rpm – 35

Current product: Caldil 500mg tab.

Manufacturer: Hoong A Corporation, China

BLISTER MACHIN – 02

Model: Wider – AIII

Buchon machinery Company ltd. Shiheung, Korea

BLISTER MACHIN – 03

Model: Wider – AIII

Capacity: 30X4 =120strip/min

Current product: Dicephin -250ml (I.V)

   Demoxil 250ml (I.M, I.V)

Only use for  powder for injection, ampoule filling

Buchon machinery Company ltd. Shiheung, Korea

BLISTER MACHIN – 04

Model: DPP- 250E1

Capacity: 148strip/min (37X4)

Max rpm –40

Set rpm – 37

Current product: cardizem

ZhejangXinfei machinery company ltd. China

BLISTER MACHIN – 05

Model: Ministar – V

Capacity: 30X4 =120strip/min

Pre heater 150^oc (upper)

Pre heater 150^oc (lower)

Sealer 200^oc

Slitter 100^oc

Hoong A Corporation, China

BLISTER MACHIN – 06

Model: Wider – AIII

Max rpm – 40

Set rpm – 37

Capacity: 120strip/min (30X4)

Buchon machinery Company ltd. Shiheung, Korea

BLISTER MACHIN – 07

Model: DPP- 250E

Capacity: 25 strip/min

Max rpm – 30

Set rpm – 28

Current product: T-cef capsule (200mg)                 

   Cosec capsule (20mg)

ZhejangXinfei machinery company ltd. China

BLISTER MACHINE – 08

Model: DPP- 250E1

Capacity: 180~140strip/ min

Current Product: Clopid 75 mg

                            Diretic 50mg

ZhejangXinfei Machinery Company Ltd. China

BLISTER MACHIN – 09

Model: DPP- 75001

Max rpm – 38

Set rpm – 32

Capacity: 120strip/min (30X4)

Current Product: E-cap 200 mg

ZhejangXinfei machinery company Ltd. China

BLISTER MACHIN – 10

Model: DPP- 75001

Max rpm – 35

Set rpm – 30

Capacity: 120strip/min (30X4)

ZhejangXinfei machinery company Ltd. China

BLISTER MACHIN – 11

Model: DPP- 250E1

Capacity: 100strip/min (25X4)

Current Product: Ulcar 150 mg

Nidocard – retard 2.6 mg

ZhejangXinfei machinery company ltd. China

BLISTER MACHIN – 12

Model: DPP- 75001

Max rpm – 38

Set rpm – 32

Capacity: 120strip/min (30X4)

Current Product: E-cap 200 mg

ZhejangXinfei machinery company ltd. China

Pharmaceutical Semisolid

INTRODUCTION:

Semisolid dosage forms are dermatological products of semisolid consistency and applied to skin for therapeutic or protective action or cosmetic function.

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, buccal tissue, urethral membrane, and external ear lining.

TYPES OF SEMISOLID DOSAGE FORMS

1. Creams,

2. Ointments

3. Pastes

4. Gels etc.

Cream preparation

Creams are viscous semisolid emulsion system with opaque appearance as contrasted with translucent ointments. Consistency and rheological character depends on weather the cream is w/o or o/w.

• Properly designed O/W creams are elegant drug delivery system, pleasing in both appearance and feel post application.
• O/W creams are non greasy and are rinsable.

They are good for most topical purpose and are considered particularly suited for application to oozing wounds.

Process Flow Chart:

(Fig: Cream manufacturing)

Ointment preparation

Ointments are soft hydrocarbon based semisolid preparation, composed of fluid hydrocarbon meshed in a matrix of higher melting solid hydrocarbon petrolatum being a tasteless, odorless, unctuous material with a melting range. Since they are greasy nature so they stain cloths. Principle ingredients forming the system hydrocarbon and silicon oil are generally poor solvent for most drugs, seemingly setting a low limit on the drug delivery capabilities of the system.  

ENVIRONMENT

Temperature: 20-30⁰ C

Humidity: 30-60 %

DOCUMENTS:

1. Standard Operating Procedure (SOP)

2. Batch Manufacturing Record (BMR)

3. Batch Packaging Record (BPR)

4. In House specification

Automatic Ointment/Cream Manufacturing Plant

  

Process Flow Chart:

(Fig: Ointment manufacturing)

Ophthalmic dosage forms

Ophthalmic dosage forms are preparations designed for application to the eye:

1. For the treatment of diseases

2. For symptomatic relief of symptoms

3. As an aid to surgical procedures

TYPES OF OPHTHALMIC PRODUCT:

Ophthalmic Products may be categorized into a number of groups:

1. Liquid preparations for application to the surface of the eye such as eye drops and eye lotion
2. Semi solid preparations such as eye ointments, creams and gels for application to the margin of the eyelid or for introduction into the conjunctival sac.
3. Solid preparations such as ocular inserts intended to be placed in contact with the surface of the eye to produce modified release of medicament over a prolong period.
4. Parenteral products for subconjuctival or intra ocular injection.
5. Liquid products for irrigation of the eye during surgical procedures.

EYE DROP:

Eye drops are aqueous or oily solutions or suspensions of one or more active ingredients for instillation into the congunctival sac of the eye. These are sterile, free from foreign particles and irritating effects. They are usually buffered and sometimes contains auxiliary substances to adjust the tonicity or viscosity, to increase solubility of the active ingredients or to stabilize the preparations. Aqueous preparations supplied to multi dose containers contain suitable antimicrobial preservatives except when. The preparations itself has adequate antimicrobial properties.

The solubility of a few drugs administered as eye drops is too low to allow their formulations as solutions. In such cases aqueous or oily suspensions are generally prepared. The solid particles must be very fine state of subdivision to prevent irritation of the cornea.

Eye drops have generally been used for administrations of antimicrobial substances like sulfacetamide and gentamicin, anti-inflammatory agent such as corticosteroids, miotics like physostigminesulphate or mydriatic drugs like atropine sulphate. Most drugs used for ophthalmic preparations are weak base or weak acids having poor aqueous solubility. In such cases, their salts such as hydrochlorides, sulphates and nitrates for weakly basic drugs and sodium for weakly acidic drugs are commonly employed.

Eye drops are generally supplied in sealed dropping bottles or sealed bottles along with a dropper. The preparation is meant to be used with in 15 to 30 days of the opening of the seal. These are usually supplied in qualities of not more than 10ml to avoid use over too long a period of time.

ADDITIVES USED IN EYE DROP

1. Vehicle: Water is the most commonly employed vehicle for eye drops formulated as aqueous solutions or suspensions. For oily preparations, vegetable oils such as peanut or sesame oil may be used.

2. Buffers: Human tears normally have a pH of about 7.2 with a good buffering capacity. Unbuffered solution with pH values of between 3.5 and 10.5 can usually be tolerated with little discomfort. Outside this pH range irritation of the eye accompanied by increased lachrymation may occur. Buffers are usually added to adjust the pH to a value that is the best with regard to the solubility or stability of the drug and which will be tolerated by the eye. The buffering agents used in eye drops are borate, phosphate and citrate buffers.

3. Tonicity modifiers: Tonicity modifiers are substances added to eye drops in order to make them isotonic with lachrymal secretions. This is essential because very hypnotic solutions can be cause temporary odema of the cornea resulting in impaired vision where as grossly hypertonic solutions can be cause irritation and discomfort to the sensitive tissue of the eye. Theoretically, eye drops should have a tonicity equivalent to 0.9% solution of sodium chloride. However it has been it has been found the human eyes can tolerate tonicity with a ranger equivalent to between 0.7% and 1.5% of sodium chloride. The most commonly employed agents for the adjustment of tonicity of eye drops is sodium chloride although potassium chloride, glucose, glycerol and buffers can also be used.

4. Stabilizers: A number of drugs used in eye drops are susceptible to oxidation in the presence of air and solutions containing such drugs should included antioxidants to improve their stability. The most common antioxidants used include sodium metasulphite, sodium sulphite, ascorbic acid and acetyl cyysteine. Stability of preparations can also be improved by replacing the air in the bottle by an inert gas such as nitrogen.

ENVIRONMENT:

Dispensing, Processing and Filling area: 100 Class

Other Utility Zone: 1000 Class

Temperature 20-25⁰C

Humidity   30-50%

Process Flow Chart:

(Ophthalmic manufacturing)

Sterile preparation

Sterile Products

Type of dosage form of sterile products:

1. Ophthalmic
2. Injectable
3. Powder for injection (Vial)

Gowning System:

In the manufacture of sterile drugs Gowning System is most important.

1) The gown must be sterilized and made of material which will not shed particles.

2) Everyone entering a clean or a sterile area must change gear garments and wear special garments which includes head, musk and footwear.

3) The number of people must be as low as possible and restricted to authorized people.

Environment Monitoring:

Environmental monitoring is one of the most important tasks in the sterile department. It is a regular check of view to take timely corrective measures for maintaining a favorable manufacturing environment, minimizing the risk of product contamination. It is also a part of validation exercise.

The environmental monitoring approach is also adopted to ensure that there is no significant risk of air borne cross-contamination.

Zonal Classification of Clean Room

Airborne particle limit  

 Aseptic Room Preparation:

The purpose of the aseptic technique is to prevent microorganisms from the environment.

To design of an aseptic room the following factors must be borne in mind:

1. Site

2. Size

3. Windows

4. Doors

5. Surfacing materials

6. Services

7. Corridors

The aseptic procedure comprises the following steps:

1) Sterilization of equipments

2) Sterilization of containers

3) Sterilization of gown.

4) Filling of the solution in the containers under aseptic conditions

5) Double door air lock system.

6) Pass box for materials.

Filling containers under aseptic conditions is the most critical step in the production cycle. This technique is filtration sterilization. HEPA (High Efficiency Particulate Air) filter is used. The most effective ones are claimed to retain 99.997% of the particles. Laminar Air flow cabinet is used under HEPA filter. Filling area is class-A zone whereas the background is class-B zone. The processing rooms must be supplied and flushed with air under controlled positive pressure.

Sterilization:

Sterile products can be classified in two classes:

1. Products which can be sterilized in their final container.
2. Products which must be processed under aseptic conditions since they cannot withstand the common methods of sterilization.

Most sterile preparations are aqueous solutions and the method of choice for sterilization is autoclave.

There are 5 types of sterilization:

CONTAINERS:

Containers for injectable preparations are made as far possible from the materials that-

>Are sufficiently transparent to permit visual inspections of the contents, except for implants.

>Do not adversely affect the quality of the preparations under the ordinary conditions of handling, shipment, storage, sale and use.

>Do not permit diffusion or across the walls of the container or yield foreign substances into the preparations. Injectable preparations may be supplied in glass ampules, vials or bottles or in other containers such as plastic bottles or bags etc.

The multiple dose containers may be used for intramuscular, subcutaneous or intracutaneous administration, but no multiple dose containers may contain a total volume of injection sufficient to permit the withdrawal of more than ten doses, unless otherwise stated in the individual monograph. The period of time between the withdrawal of the first and final dose should not be unduly prolonged.

CLOSURES

Vials or bottles with fitted with suitable closures a good seal, prevent the access of microorganisms and other contaminants and usually permit the withdrawal of a part of the whole of the contents of the container without removal of closures. The plastic of rubber materials of which the closure must be compatible with the preparation and be sufficiently firm and elastic to allow the passage of a needle with minimal shedding of particles and to ensure that the puncture is released when the needle is withdrawn.

  

AMPOULE:

Ampoules are the walled glass containers which after filling, are sealed by fusion of the glass. The contents are withdrawn of the glass. The contents are withdrawn after rupture of the glass for one time use.

VIALS:

Vials are thick glass container for dry powders injectable product in which suitable solvents are added to make solution or suspensions just before injections.

WATER FOR INJECTION:

The water which is used as solvent in parenteral product manufacturing is known as water for injections. This water should be highly purified and free from microorganism.

Process Flow Chart:

(Sterile product manufacturing)

Process Flow Chart:

(Vial manufacturing)

Process Flow Chart:

(Ampoule manufacturing)

INFUSION:

According to the FDA Large volume parenterals means a terminally sterilized drug product packaged in a single dose container with a capacity of 100 mi or more and intended to be administered or used as man. It includes IV infusion, irrigating solution, peritoneal dialysis and blood collecting with anticoagulant. These solutions are usually administered by intravenous infusion to replenish body fluid or electrolytes or to provide nutrition. They are usually administered in volumes of 100 ml or1 L or more per day by slow IV infusion with or without a controlled rate infusion system.

Drug International intravenous fluid manufacturing plant may be regarded as one of the most technologically advanced plants in Bangladesh. In designing the whole process, special care has been taken by providing absolute sterile manufacturing condition. The prime feature of the process is that there is no human physical contact with the product at any given time. This has been ensured by way of a series of fully automated manufacturing procedure including robotics. The bottle pack aseptic system (Form-fill-seal or FFS) is a unique and innovative manufacturing technology. Plastic bottles are blow moulded, filled with the solution and seal under sterile condition, in a single working cycle where there is no environmental exposure or human contact during manufacturing. The IV fluids are presented in a scientifically designed bottle where there is an extra protective eurohead cap and a resealable rubber disk. The whole process is performed in a class 100 clean room. The air inside this room is cleaned up to 100 particles per cubic feet passing through HEPA (High Efficiency Particulate Air) filter. This ensures the highest standard of quality and purity in order to ensure the highest level of safety.

References:

1. The Theory and practice of Industrial Pharmacy, 

    (Leon. Lachman, H.A. Lieberman, J.L. Kanig)

2. Encyclopedia of Pharmaceutical Technology

    (James Swarbrick - Taylor and Francis)

Manufacturing Oral Liquid

 The oral use of liquid pharmaceuticals has generally been justified on the basis of ease of administration to those who have difficulty in swallowing solid dosage forms. A drug administed in solution is immediately available for absorption and in most case, is more rapidly and efficiently absorbed than the same amount of drug administered in a tablet or capsules.

Pharmaceutical dosage form has 3 type of oral liquid

1. Syrup

2. Suspension

3. Emulsion etc.

Syrup:

Syrups are oral preparations in which drugs are homogeneously distributed in a solution.

Suspension:

Suspensions are two phase heterogeneous systems in which solid particles are dispersed of suspended in liquid with the help of suspending agents.

Emulsion:

Emulsions are two phase systems in which two immiscible liquids are homogeneously distributed in a liquid with the help of emulsifying agent

Process Flow Chart:

(Oral liquid manufacturing)

  

WATER SUPPLY:

Demineralized water is supplied from water treatment plant. This water is then heated with steam at temperature of 180⁰ C. Then this hot water is used in the preparation of sucrose syrup which aids the solubility of ingredients and prevents microorganisms

Equipment used in oral liquid unit:

1. Syrup Vat

Anounts: 03

            Made in India

2. Pump

3. Homoginetor

4. Filter

DOCUMENTS:

1. Standard Operating Procedure (SOP)

2. Batch Manufacturing Record (BMR)

3. Batch Packaging Record (BPR)

4. Material Requisition Sheet (MRS)

4. In House specification

 

Pharmaceutical Capsules

Capsules are a solid dosage form enclosed in a hard shell or soft gelatin coating. When taken with water, the capsules' coating becomes slippery and easy to swallow.

i) Hard Gelatin Capsule

It is a solid dosage form in which medications are encapsulated in a two part empty hard gelatin capsule shell. The upper and small part is called ‘CAP’ and the remaining large part is called ‘BODY’. There are 8 different sizes of capsule shell(000,00,0,1,2,3,4,5) with different fill volume. Normally 0 and 2 sized shells are widely used. The shell of hard gelatin capsules basically consists of gelatin, plasticizers and water. Modern day shells may, in addition, consist of preservatives, colours, opacifying agents, flavours, sugars, acids, enteric materials etc. The gelatin is marketed in a large number of varieties and a specific quality and gelatin having specified gel strength, viscosity, iron content etc. should be selected for capsules. The variations in gelatin properties arise because of changes in molecular weights and methods followed in conversion into gelatin.

There are two filling process:

§  Pellet filling

§  Granules filling

Process:

Problems occurred during encapsulation:

1. Blank shell
2. Shell lock in channel
3. Shell breaking
4. Improper filling of shell
5. Improper fitting of shell in dies if compressed air pressure is not adjusted properly.
6. Improper or large size of pellets may cause blockage of nozzle. So shells are left empty.

 EQUIPMENTS:

1. Automatic Capsule Filling machine

Capacity: 65000 capsule/hour

Made in China

2. SEJONG

Model: SF-30

Capacity: 40000capsule/hour

3. Semi automatic capsule filling machine

Model: SCORPIO

Capacity: 7500cap/hr

Process of Gelatin Capsule Manufacture:
 

ii) Soft Gelatin Capsule

A softgel (or a soft gelatin capsule) is a solid capsule (outer shell) surrounding a liquid or semi-solid center (inner fill). An active ingredient can be incorporated into the outer shell, the inner fill, or both. These capsules are available in a variety of shapes, the common shapes being spherical, oblong and elliptical. Size wise also the range is bigger and capsules of capacities ranging from 0.1 ml to 30 ml are used. The composition of soft gelatin capsule shells is similar to the hard gelatin capsules except that a larger proportion of plasticizer is incorporated to make them soft and elastic.

Composition shell

The outer shell is composed of a gelatin or potato starch matrix. Gelatin matrix consists of gelatin, plasticizer, solvent and optional ingredients such as flavors and colorants.

Gelatin - Bovine, porcine, or piscine (fish) origin. Comes in a variety of bloom strengths, the higher the bloom strength, the more resilient the gel. Most oil based fills are encapsulated using a bloom strength of 150. When polyethylene (PEG) based fills are used, a higher bloom strength is generally used.

The limitations of bovine (i.e. bovine-related diseases) and porcine (i.e. not kosher) gelatin may be overcome by piscine (fish) gelatin.

Plasticizer - Glycerin and Sorbitol Special are the two most common plasticizers. Glycerin is generally used with oil based fills. Sorbitol Special is used with PEG based fills. Sorbitol is not soluble in PEG and therefore will not leach out of the shell into the PEG base fill like Glycerin would. Sorbitol Special is formulated to inhibit sorbitol from crystallizing out in the gelatin shell. Do not substitute Sorbitol for Sorbitol Special.

Solvent   -Water

Optional Ingredients   -Colors

                                 -Flavors

Incompatibility

Avoid aldehydes which can lead to cross linking (pellicle formation) of the gelatin, and poor dissolution of the gelatin capsule in water. This may be overcome by adding enzymes to the dissolution media, (see FDA Guidelines)

Drugs sensitive to water can degrade (e.g. ranitidine) or undergo polymorphic conversion (e.g. terazosin). 

Compounds (especially those of high water solubility) can migrate from the fill into the shell or get trapped in a hydrophobic matrix resulting in poor dissolution and loss of bioavailability. 

Soft Gelatin Encapsulation Processes and Equipment 

Rotary Die process

Two ribbons of gelatin are fed continuously into a rotating die assembly and are simultaneously formed into the two halves of a capsule. The ribbons converge adjacent to a fill injector. The fill injector is actuated by a pump which measures and dispenses the appropriate volume of fill material into the capsules. The filled capsules are subsequently sealed as the die assembly rotates. This process permits accurate and reproducible fill uniformity.

Pump heads are available for fill weights as low as 100 mg. For oral dosage forms, the fill weight ranges from 100 mg up to about 1 gram.    

The following should be monitored/controlled:

1. Gelatin temperature

2. Fill temperature

3. Ribbon thickness

4. Seal or seam width

5. Fill quantity

Following encapsulation, the capsules undergo drying in a tumble drying tunnel with an elevated temperature and a large volume of forced air. From the drying tunnel, the capsules are transferred onto trays and placed into a low humidity drying room. Drying is a dynamic process, and the goal is to have the gelatin shell return to its equilibrium moisture content in the range of 6 - 8%.Oil fills dry faster than PEG fills, and typically reach a shell moisture content of 6 to 8% within 24 hours.   

MANUFACTURING PROCESS:

Soft gelatin capsules are generally manufactured by the plate or the rotary die process.

In the plate process a sheet of soft gelatin is placed on a plate having a number of dies and the sheet is drawn into the dies by application of vacuum. The material is then filled in and another sheet of gelatin overlaid. Then a die press descends which seals and cuts out the capsules. This process can, at best, be considered to be semi-automatic.

The rotary die machines, of which several versions are now in the market, operate on a continuous basis and are suitable for large scale manufacture. In rotary machine two continuous gelatin sheets are produced on two rotating drums and are conveyed to two cylinders with matching dies rotating in the same direction. As the gelatin sheets come between the dies the material to be filled is injected through a metering device causing the sheet to swell up and form capsules. Simultaneously the pressure exerted by converging di8es seal and cuts out the capsules. The finished capsules, which fall on a conveyor belt, are carried through rapid dryers, where a greater part of the moisture goes off. The remaining moisture is removed by passing capsules through drying channels into which air is passed under pressure. Most of the early machines could fill liquid preparations only. Recently Accogel or Stern machines capable of filling powders as well have been marketed by Lederle Laboratories.

Rotary Die Encapsulating Machine for Soft Gelatin Capsule:

Process flow chart:

(Soft gelatin capsule manufacturing)

References:

1. Handbook of Pharmaceutical Granulation Technology

    (Dilip M. Parikh)

2. Encyclopedia of Pharmaceutical Technology

    (James Swarbrick - Taylor and Francis)

3. The Theory and practice of Industrial Pharmacy, 

    (Leon. Lachman, H.A. Lieberman, J.L. Kanig)

4. sunkingpm.com
5. hl-jn.com