This document provides information about Albendazole tablets (brand name Bendax) as an anthelmintic drug. It discusses the advantages of tablets as a drug delivery system. It describes the classification, ingredients, mechanism of action, side effects, dosage, and interactions of Albendazole tablets. The key points are: Albendazole tablets are an immediate-release anthelmintic tablet. It acts by inhibiting worm glucose uptake and energy levels. Common side effects include abdominal pain and headache. The recommended dosage is 400mg once daily for most infections. Drug interactions can occur with antiepileptics, antacids, grapefruit, and dexamethasone.

1. Anthelmintics tablet
1. Advantage of tablet (introduction )
2. Type of tablet
3. Quality requirements
4. Manufacture of tablet
5. technical problems during tableting
6. how to solve this problems
7. tablet coating
8. Advantages over other dosage form (comparison between albendasole
tablet and other anthlmintics) why I should use this product????
9. Anthelminitic definition
10. Anthelmentic classification &Name of Anthelimentic tablet
11. Ingredients: including glidants and fillers and their advantages (Type of
coating ) &-uses of each ingredient
12. Type of worms that the drug acts against
13. general uses
14. Site of action & Biological Effect
15. Mechanism of action
16. Contraindications
17. Side effects
18. How to consume ! Dose and take the Drug
19. Interaction è other drugs & precautions

2. Advantages of tablets as a drug delivery system:
1) Convenient and safe way of drug administration (ease of
swallowing, especially when coated).
2) Compared to liquid dosageforms tablets have more chemical and
physical stability.
3) They offer the greatest doseaccuracy and least content Variation.
4) Lowest costof all oral dosageforms and giving an elegant
preparation of consistent quality and low price.
5) Tablets are convenient to handle; lightest and compactof all oral
dosage forms.
6) Easiest and cheapest to package and shipment
7) They can give special release profile product, suchdelayed or
extended – released tablet.
8) They have the best combined properties of chemical, mechanical
and microbiological stability.
Type of tablet:
Classification of tablets is based on their drug – release characteristic
* Tablets can be classifiedinto three types:
(1) Immediate release:
released rapidly after administration Eg: disintegrating, chewable, effervescent,
sublingual, and buccaltablets.
Extended release:(2)
Modified-release tablets should normally be swallowed intact. The drug
released from extended-release tablets slowly at nearly constant rate.
:( anthlimintic tablet )e(3) Delayedreleas
For delayed-release tablets the drug is liberated from the tablets elabsed period
of time after administration. After this period, the release is normally rapid.
- Most common type is enteric tablet, for which the drug released in the upper
part of small intestine after the preparation has passed the stomach. However,
a delayed-release can also be recombined with a slow drug release, e.g. for local
treatment in the lower part of the intestine or the colon.

3. Quality requirements
1. Tablet should contain the correct-effective- doseof the drug.
2. Appearance of tablet should be elegant, and its physical properties as
weight, size and appearance should be consistent.
3. Drug should be released from the tablet in a controlled and reproducible
way.
4. The tablet should be biocompatible (not include excipients or
contaminants that can cause harm to patient.)
5. Tablets should be of sufficient mechanical strength to withstand fracture
and erosion during handling.
6. Tablets should be physically and chemically stable during the lifetime of
the product.
7. The tablet should be acceptable by the patient and packed in a safe
matter.
Manufacture of tablet
 Tablet formation usually occurs in three stages:
1. Die filling: which is accomplished by gravitational flow, where powder
from the hopper fills the die which is closed at its lower end by the lower
punch.
2. Tablet formation: The upper punch lowers and enter the die, the lower is
compressed until the tablet is formed, lower punch can be stationary or
move upward the die, after maximum compressionis achieved, the upper
punch leaves the compressed powder“Decompressionphase”
3. Tablet ejection:The lower punch raises until reaches the level of the top
of the die and the tablet is pushed away from the die.
This process canoccurin either single punch press “Eccentric press”which
possesses onedie and one pair of punches, this produceabout 200 tablets a
minute and is used for small scale productionof tablets. It can also be produced
on a large-scale by using the rotary press “multi station press” which uses up
to 60 presses which can produce10000 tablets a minute.
Tablets can also be produced through wet or dry granulation where wet
granulation uses alcohols that helps formation of the granules and dries quickly,
the dry granulation mainly relies on pressure.

4. Technical problems during tableting
1. High weight and dosevariation of tablets
2. Low mechanical strength of tablets
3. Capping: it is partial or complete separation of the top or bottom of tablet
due air-entrapment in the granular material.
4. Lamination: it is separation of tablet into two or more layers due to air-
entrapment in the granular material.
5. Cracking:it is due to rapid expansion of tablets when deep concave
punches are used.
6. Unequal distribution of forces during compression
7. Too much pressure
8. presence of fine powders of granules
9. Chipping: it is breaking of edges of tablet due to in correctmachine or
very dry granules .
10.Sticking and binding: it is the adhesion of granulation material to the die
wall or punch tips
11.Picking:it is the removal of material from the surface of tablet and its
adherence to the face of punch.
12.High friction during tablet ejection
13.Mottling: improper mixing of granular material due to a colored drug,
which has different color than the rest of the granular material
14.Double impression: it is due to free rotation of the punches, which have
some engraving on the punch faces
How to solve some problem of manufacture ?????
Capping
granulation
granulation
 Remove all fine particles through mesh screen
 Add hygroscopic substanceto treate the loss of moisture
and loss of binding action
 Increase amount of binder
Tablet press
 Use flat punches
 Make proper sitting of lower punch
Tablet press
Lamination  Modify mixing through adding absorbent
 Use less amount of lubricant
Chipping  Dry the granules to increase lubrication
 Add hygroscopic substance
 Polish the punch edges

5.  Polish the dye to make it cylindrical
Cracking  Add fines or reduce granules size
 Moisten the granules and add binder
Sticking  Increase lubricant
 Reduce the amount of binder
Picking  Increase lubrication
 Add high melting point materials
Tablet coating :
1. Reasonsfor coating :
 Modifying drug release as in enteric coated products .
 Improving drug appearance
 Masking unpleasant taste and odours .
 Protecting the drug from surrounding environment .
2. Types of coating :
Sugar coating
Film coating
Compressioncoating
Functional coating (enteric coating )
3. What is the enteric coating & why I need it in the anthlimentic tablet
??
Anthlimentic tablet dissolve in intestine not in stomach so the drug
shouldn’t be affected by low PH in stomach through coating .
Materials used for enteric coatings include fatty acids , waxes , shellac
Plastics and plant fibers ….
The commenly used is ester of phthalic acids
They also contain plasticizer that prevent film from being brittle
Examples :
Shellac , cellulose acetate phthalate , polyvinyl acetate phthalate PVAP

6. Advantages over another dosage forms :
Name of drug bendax tablet
200mg
Albendazole
chewable tablets
Bendax
suspension
Route of
administration
Oral , swallowed may be chewed,
swallowed whole or
crushed and mixed
with food or liquid,
and the tablets should
be crushed before
being given to a
young child.
Oral
Advantages
And
disadvantages
 Accurate dose
than the suspension
 You don’t need
to add flavouring
agents because of
coating
 You don’t need
to add sugar like
chewable tablets ,
sugre will decrease
the stability of the
tablet and require
additional
preservative
materials
 Good for children
 Better than
suspension that it
has accurate dose
But it require
higher costthan
bendax tablet
Not accurate dose
You need high
cost to mask the
taste of drug
Less stable than
tablets
Less shelf life

7. -Anthelmentic Definetion
-The term anthelmintic is restricted to drugs
acting locally to expel parasites from gastro
intestinal tract. There are several types of
worms which penetrate other tissues, drugs
which act on these parasitic infections
are also known as anthelmintics.The worm parasites of man belong to two
phyla: Nemathelminthes (round- worms) and platyhelminthes (flatworms). The
roundworms include hookworm, whipworm,pinworm Strongyloides stercoralis
Trichinella spiralis and Wuchereria bancrofti
CLASSIFICATION:
Anthelmintics are classified based upon their chemical structures.
1) Piperazines: eg. Diethylcarbamazine citrate, Piperazine citrate.
2) Benzimidazoles: eg. Albendazole, Mebendazole, Thiabendazole.
3) Heterocyclics: eg. Oxamniquine, Praziquantel.
4) Natural products:eg. Ivermectin, Avermectin.
5) Vinyl pyrimidines: eg. Pyrantel, Oxantel.
6) Amide: eg. Niclosamide.
7) Nitro derivative: eg. Niridazole.
8) Imidazo thiazole: eg. Levamisole.

8. -Name of anthelmentic tablet (Bendax)
Generic name: Albendazole
( Bendax film coated tablet)
-Mode of each ingredients (includingfiller &their advantages)
Albendazole 200 mg:It prevents newly hatched insects(worms)
from multiplying in your body
 Lactose Monohydrate:pharmaceutical lactose excipients
 Avicel PH 101:Reduce sensitivity of the wet mass over
wetting, faster disintegration
 Maize starch:Excipients for the pharmaceutical industry
 PVP K30: used as binder in manufacturing the tablet
 Croscarmellose sodium :facilitate the breakup of the
tablet in the intestinal tract afteroral administration ,
allows enhanced bioavailabilityof the drug through
superior drug dissolution
 Aerosil:high purity , low humidity content, improve
distribution of active pharmaceutical ingredients , used as
anti-setting ,thickening& anti sagging agent
 Sodium lauryl sulphate: used as surfactant
 Magnesium Stearate:prevents ingredients from adhering
,has lubricating properties
 Methocel E-15:allow coating process of the tablet and
improve physical properties
 Talc Powder: used as inert filler
 Titanium dioxide: tablet coating
 Polyethylene glycol 6000: tablet lubricant

9. Mechanism of action of Bendax:-
 -Bendax is a broad spectrum anthelmintic, acting against intestinal
and tissue helminthes , it has also antiprotozoal actions. It exhibits
vermicidal, ovicidal and larvicidal activities. It immobilizes and kills
the susceptible worm by inhibiting tubulin polymerization and
blocking glucose uptake, thereby depleting the energy levels until
it becomes immobile and dies.
 -Albendazole (active ingredient) causes degenerative
alterations in the intestinal cells of the worm by binding to
the colchicine-sensitive site of tubulin, thus inhibiting its
polymerization or assembly into microtubules. The loss of the
cytoplasmic microtubules leads to impaired uptake of glucose
by the larval and adult stages of the susceptible parasites, and
depletes their glycogen stores.
 -Degenerative changes occur in the endoplasmic reticulum,
the mitochondria of the germinal layer, and the subsequent
release of lysosome.
 Side effects of bendax :-
 Bendax is generally well tolerated with minor and rare side
effects have been reported during short treatment:
 -Common side effect : abdominal pain and headache.
 -Uncommon side effect : diarrhea ,nausea ,vomiting, dizziness,
itchiness and /or skin rashes.
 -Rare side effects: bone pain, proteinuria, and low red cell count.
Also leucopenia and transiently raised hepatic enzymes were
reported.
 -Very rare side effects : hypersensitivity reactions including rash,
pruritis and urticaria.
 During prolongedhigher doses ofBendax :symptoms were
usually mild and resolved without treatment.
 When bendax is used in hydatid Diseases and
Nuerocysticercosis:
 -Common side effects:abnormal liver function tests , abdominal
pain, nausea/vomiting, headache, dizziness/vertigo, raised
intracranial pressure, meningeal signs, reversible alopecia (thinning
of hair, and moderate hair loss) and fever.

10.  -Uncommon side effects: leucopenia and hypersensitivity
reactions, including rash and urticaria.
 -Rare side effects:granulocytopenia , pancytopenia,
agranulocytosis, or thrombocytopenia. Bone marrow suppression,
patients with liver diseases ,including hepatic echinococcosis ,
appear to be more susceptible.
 Contra-indications :-
 -People with hypersensitivity to the benzimidazole class of
compounds including Albendazole or any of the drug components.
 -During pregnancy:
 Bendax is contraindicated during pregnancy, and for one month
prior to conception. In order to avoid administering albendazole
during early pregnancy ,women of child bearing age should initiate
treatment during the first week of menstruation or after a negative
pregnancy test. If a patient becomes pregnant while talking this
drug ,albendazole should be discontinued immediately.
 Scientific reason: Pharmacokinetic studies have shown trace
amounts of albendazole appears in semen. Given its potential
for teratogenicity, the manufacturers advise the male sexual partner
should use adequate protections. It should not be taken when
pregnant, and within one month after taking this drug.
 (N.B: Adequate human data on use bendax during lactation are not
available. Therefore breast feeding should be discontinued during
and for a minimum of 5 days after treatment).
 Storage :-
 Store in room temperature (not exceeding 30C) in an
airtight container and keep away from excess heat,
moisture and children.
 Price in Egypt : 3,25
 Produced by :
 SIGMA pharmaceutical industries – Egypt – S.A.E.

11.  Dosage of Bendax:-
 For adults and children over 2 years:-
 400 mg once daily (2 tablets or 20 ml suspension) *
 * Single dose:Enterobiasis, Ancylostomiasis, Ascariasis and
Trichuriasis.
 * days: Strongyloidiasis, Taeniasis, Hymenolepiasis and mixed
or heavy infections.
 * 5 days: Giardiasis.
 -For children below 2 years:- 200 mg as a single dose(10 ml
suspension).
 Neurocysticercosis:-- 400 mg (2 tablets or 20 ml suspension) twice
daily for 8-30 days.
 Every 4 weeks must be followed by 2 weeks albendazole free
interval
 N.B: Patients weighing less than 60 kg: 7.5 mg/kg twice daily.
 Administration:-
Take with food ,Albendazole is only given orally.
Drug interactions&precautions:-
Antiepileptics:
The drugs carbamazepine, phenytoin, and phenobarbital lower the
plasmatic concentration and the half life of albendazole.
Antacids/histamine H2 antagonists:-
The drug cimetidine heightens serum albendazole concentrations, and
increases the half life of albendazole.[14] This might be a helpful
interaction on more severe cases, because it boosts the potency of
albendazole.
Fosphenytoin: Fosphenytoin decrease level of albendazole by
increasing metabolism .

12. Grapefruit:
Grapefruit will increase the level or effect of albendazole by affecting
hepaticintistinal enzyme CYP3A4 metabolism .
Dexamethasone:
Dexamethasone increasing level of albendazole by unspecified
interaction mechanism .
Precaution
-Monitor blood counts and liver function.
-Patients being treated for neurocysticercosis should receiveappropriate steroid
and anticonvulsant therapy as required.
-It is important to take iron every daywhile you are being treated for hookworm
infection because it causes anemia.
-Administer within 7 days of start of normal menstruation in women of
childbearing age .
-Adequate non-hormonal contraceptive measures must be taken during and for 1
month after therapy.
-Perform liver function tests and blood counts before and every 2 wk during
high dosetherapy of hydatid disease.
-It may cause bone marrow depression.
-It may cause dizziness. Do not drive or perform other possibly unsafe tasks
until you know how you react to it.

13. Ceutics assignment
Anthlimintic tablet
Group members :
‫مريم‬‫برعي‬ ‫عباس‬216
‫حسن‬ ‫محمد‬ ‫مروة‬213
‫اسكندر‬ ‫سامي‬ ‫كريستين‬167
‫جابر‬ ‫محمد‬ ‫تسنيم‬81
‫محمود‬ ‫حمدى‬ ‫فاطمة‬161
‫رفاعي‬ ‫مجدى‬ ‫ضحى‬146

14. References:
 Modern pharmaceutics book
 Pharmaceutical product development book
 www.medicinep.com
 http://www.pharmalearners.com/tablet