طرق النحضير الفني و التصنيع التكنولوجى للفايروكير حسب براءة اختراعه الاميريكاني

THE FIRST SUBJECT :
ACTIVE INGRIEDENTS EXTRACTION AND SPRAY DRYING TECHNIQUE TO GET THE ACTIVE INGREDIENTS OF THE HERBAL MIXTURE IN A PURE AND CONCENTRATED POWDERED FORM (WITHOUT ALTERATION OF THEIR ACTIVITY & GET RIDE OF THE UNWANTED OTHER INGREDIENTS ) TO MANUFACTURE THE HERBAL MIXTURE IN THE FORM OF SMALL TABLETS ( WHICH IS THE BEST TRUSTABLE PHARMACEUTICAL DRUG FORM ) HAVING THE FOLLOWING ADVANTAGES : 1- Small tablet of dried extract of the wanted active ingredients of herbal mixture have the highest treatment efficacy and patient tolerance ( it is the first manufacture technique to get medicinal herbal mixture as pure & concentrated small tablet form ) 2- getting ride of the unwanted herbal mixture ingredients giving the drug of plant origin the least side effects & the unwanted interactions of the numerious plant mixture ingredients so the drug is completely safe and easily Quality Controlled by Quantitative Assays ( by methods of HPLC & GAS Chromatography )













العنصر الثانى :
THE SECOND SUBJECT :

Spray drying is very important technical method used to dry
aqueous or organic solution, emulsions etc. Spray drying can
used to do differential separation of active soluble gradients
in pure and concentrated powder form from herbal mixture
emulsion with added ANAlAr organic solvents e.g . polyethylene glycol 5%, ethanol 70 % glycerol 20% and carbon dichloride 5% . also used to preserve food or simply as a quick drying method .it also provides the advantage of weight and volume reduction. It is the transformation of feed from a fluid medium state into a dried particulate form by spraying the feed into a hot drying medium. Intensive research and development during the last two decades becoming a highly competitive means of drying a wide variety of products. The range of product application continues to expand, so that today spray drying has connections with many things we use daily.







spray drying principle. Spray drying involves evaporation of moisture from an ato-
mised feed by mixing the spray and the drying medium. The drying medium is typically rotary hot air .the drying proceeds
until the desired moisture content is reached in the sprayed
particles water content not exceed 6% and the product is then
separated from the air. The mixture being sprayed can be
a solvent, emulsion, suspension or dispersion.


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dispersion of the feed the complete process of spray drying basically consists of a
solution in small droplets. Sequence of four processes:

the dispersion can be achieved with a pressure nozzle, a two
fluid nozzle, a rotary disk atomizer or an ultrasonic nozzle.
So different kinds of energy can be used to disperse the iquid
body into fine particles diameter is very small less than100
micrones with density more than 0.6 gm/cm.. The selection
upon the atomizer type depends upon the nature and amount
of feed and the desired characteristics of the dried product ,

the higher the energy for the dispersion , the smaller are the
generated droplets . Example :

100 ml of a solution are sprayed, resulting in approx. 8× 108= 800,000,000 drops (25 microns) representing approx.. 12m 2 of surface area. This demonstrates that the solvent (mainly water) is vaporized extremely quickly.



mixing of spray & the manner in which spray contacts the drying Hot air is an
drying medium (air) important factor in spray dryer design, as this has great bearing on dried product properties by influencing droplet behaviour during drying.
This mixing is an important aspect and defines the method of spray drying :



A- Co – current flow : the material is spayed in the same direction as the flow of
hot air through the apparatus. The droplets come into c-
ontact with the hot drying air when they are the most moist.
The product is treated with care due to the sudden vaporiz-
ation.

B-Counter-current flow : The material is sprayed in the opposite direction of flow of the hot air. The hot air flows upwards and the product falls through increasingly hot air into the collection tray . The residual moisture is eliminated ,and the product becomes very hot . This method is suitable only for thermally stable products .

C-Combined- flow : the advantages of both spraying methods combined. The p-
roduct is sprayed upwards and only remains in the hot zone
for a short time to eliminate the residual moisture. Gravity
then pulls the product into the cooler zone . Due to the fact
that the product is only in the hot zone for a short time. The
Product is treated with care.


D-Disk atomizer (rotary wheal)which is the best method used :


The material to be sprayed flows onto a apidly rotating atomizing disk and is convertad to a fine mist. The drying air flows in the same direction . the product is treated with care . just as in the co-current flow method .



open-cycle & closed Air is used as drying medium . the air stream is heated
cycle system electrically or in a burner and after the – process exhau-
sted to atmosphere . this is a (open-cycle system) if the
heating medium is recycled and reused, typically an inert
gas such as nitrogen, this is a (closed-cycle system) these
layout is typically chosen, when flammable solvents,to-
xic product or oxyger sensitive products are processed.


The most common type of spray dryer is the open-cycle,
Co-current or rotary wheal spray dryer . in such a design, the atomized feed and the drying air is simultaneously injected into a spray drying chamber from the same direction .



drying of spray As soon as droplets of the spray come into contact with
(remval of moisture) the drying air, evaporation takes place from the saturat-
ed vapour film which is quickly established at the drop-
let surface Due to the high specific surfaca area and the existing temperature and moisture gradients , an intense heat and mass transfer results in an efficient drying. The evaporation leads to a cooling of the droplet and thus to a small thermal load. Drying chamber design and air flow rate provide a droplet residence time in the chamber, so that the desired droplet moisture removal is completed and product removed from the dryer before product temperatures can rise to the outlet drying air te- mperature . Hence, there is little likslihood of heat damage to the product .

Separation of in principal, two system are used to separate the product from
product and air the drying mediun:

1-Primary separation of the drying product takes place at
the base of the drying chamber

2- Total recovery of the dried product in the separation
equipment


Most common separation equipment is the cyclone .,Based
On inertial forces, the particles are separated to the cyclone
Wall as a down- going strain and removed. Other systems
are electrostatic precipitators , textile (bag) filters or wet
Collectors like scrubbers.

العنصر الثالث :
THE THIRD SUBJECT :
Possible applications : There are 4 general princibles are listed hereby
Used for an enormous list of materials which are successfully Spray Dried :


Application
Goal / use

Spray drying





Drying of inorganic
And organic products

micronzation


Reduction of products
Particle size


Micro encapsulation




A liquid product is embed-
ded in a solid matrix

Englobing





A solid product is embed-
ded in another solid or a
Mixture of solids















العنصر الرابع :
THE FORTH SUBJECT :
THE FACTORY MANUFACTURING OF THE HERBAL MIXTURE DRIED PURE & CONCENTRATED ACTIVE INGREDIENTS IN THE FORM OF SMALL TABLETS
The herbal mixture hot spraying dried extract of the wanted active ingredients is following the GMP SPECIFICATIONS of the factory manufacturing American & Europian PHARMACOPIA as :
The powder particle size is not more than 100 microns
The powder water content is less than 6 %
The powder density is not less than 0.6 gm / ml
Which are very important GMP Specifications to manufacture a tablet form which is very difficult to get in any herbal mixture not prepared by that technique ( Hot Spray drying of herbal mixture extract of the wanted active ingredients ).
The herbal mixture hot spraying dried extract of the wanted active ingredients as a powdered form is following the factory manufacture production as a tablet form as :
The powdered form is easily to form tablets by binding the particles by natural excipients by ( PHARMACARE FZE PHAMACEUTICALS MANUFACTURER
JEBEL ALI , DUBAI –UAE ) WHICH ARE :
1- CELLULOSE MICROCRYSTALLINE ( Avicel PH 302 )
2- STARCH GLYCOLATE ( Viva star – P )
3- CELLULOSE POWDER
4- KOLLIDONE CL-M
5- LACTOSE MONOHYDRATE
6- TALC
7- MAGNESIUM STEARATE

THE FINAL DOSAGE FORM IS TABLETS ( 300 mg of Active Herbal Ingredients )
THE TREATMENT COURSE 2 SMALL TABLETS PER DAY FOR 3 MONTHS
THE TREATMENT CURE RATE MORE THAN 95 %
THE ENCOUNTERED SIDE EFFECTS RARE (good tolerance & no interactions )