Aluminium phosphate adjuvent Causes mild irritation, dryness, and dermatitis on skin contact. causes redness, conjunctivitis, and short-term mild irritation on eye contact

1. PHARMACEUTICAL EXCIPIENT
AND FORMULATION OF A
DOSAGE FORM
Presented by:
All An Shariah Brishti
Sec: 13th (B)
Daffodil International University

2. Aluminum Phosphate Adjuvant
Synonyms:
Adju-Phos
Aluminum Hydroxyphosphate
Rehydraphos.
Chemical Name:
Aluminum phosphate
Functional Category:
Adsorbent; vaccine adjuvant.
Applications:
used in parenteral human and veterinary
vaccines.
Description:
white hydrogel that sediments slowly and
forms a clear supernatant.
Stability and Storage Condition:
stable for at least 2 years when stored at 4–
30▫C in well-sealed inert containers.
Safety:
 Causes mild irritation, dryness, and
dermatitis on skin contact.
 causes redness, conjunctivitis, and
short-term mild irritation on eye contact

3. Nonproprietary Names:
BP: Strong Ammonia Solution
Ph-Eur: Ammonia Solution, Concentrated
USP-NF: Strong Ammonia Solution
Synonyms:
Ammoniae solution concentratat;
Aqua ammonia
Functional Category:
Alkalizing agent.
Ammonia Solution
Application:
 used as a buffering agent , to produce
more dilute ammonia solutions.
 dilute ammonia solution is used as a
counterirritant to neutralize insect bites
or stings.
Description:
occurs as a clear, colorless liquid having
an exceedingly pungent characteristic odor.

4. Stability and Storage Conditions:
 stored in a well-closed container, protected
from the air, in a cool, dry place.
Safety:
 causes severe pain in the mouth, throat, and
gastrointestinal tract.
 Burns to the esophagus and stomach may
result in perforation.
 vapor is irritant to the eyes.
Handling Precaution:
 Before containers are opened, they
should be well cooled.
 closure should be covered with a
cloth while opening.
 should not be tasted and inhalation
of the vapor should be avoided.
 Eye protection, gloves, and a
respirator are recommended.
Ammonia Solution

5. Synonyms:
Alginic acid, Ammonium salt;
Ammonium poly mannuronate;
Keltose.
Structural Formula: (C6H8O6)n
Functional Category:
Diluent; emulsifying agent;
Stabilizing agent; thickening agent.
Applications:
 used as a color-diluent, emulsifier, film-former,
and humectant.
Description
occurs as white to yellowish brown filamentous or
powdered forms.
Ammonium Alginate

6. Stability and Storage Conditions:
 stable if stored at low relative humidities and cool
temperatures.
Incompatibilities:
 Incompatible with oxidizing agents and strong
acids and alkalis.
Safety:
 regarded as a nontoxic and nonirritant material,
excessive oral consumption may be harmful.
Handling Precautions:
 Observe normal precautions
appropriate to the circumstances
and quantity of the material
handled.
 Eye protection, gloves, and a dust
respirator are recommended.
Ammonium Alginate

7. Nonproprietary Names:
BP: Ammonium Chloride
USP: Ammonium chloride
Synonyms:
Ammonii chloridum; Ammonium muriate;
E510; Sal ammoniac;
Functional Category
Acidifying agent; therapeutic agent.
Ammonium Chloride
Description:
 white, colorless, odorless, granular
powder with a cooling, saline taste.
Application:
 used as an acidifying agent in oral
formulations.
 used as an expectorant in cough
medicines.

8. Stability and Storage Conditions:
Chemically stable, Store in airtight
containers in a cool, dry place.
Safety:
 toxic by SC, IV, and IM routes, and
moderately toxic by other routes.
 Ammonium salts are an irritant to the
gastric mucosa
 induce nausea and vomiting.
Incompatibilities:
 Incompatible with strong acids and strong
bases
Handling Precautions:
 must be kept well away from nitrites and
nitrates during transport and storage.
 must be stored in a dry place, and effluent
must not be discharged into the drains
without prior treatment.
Ammonium Chloride

9. Ascorbic Acid
Synonyms:
Acidum ascorbicum; cevitamic acid;
vitamin C.
Chemical Name:
L-(þ)-Ascorbic acid
Structure:
Functional Category:
Antioxidant; therapeutic agent.
Applications:
 used as an antioxidant in aqueous
pharmaceutical formulations at a
concentration of 0.01–0.1% w/v.
 used to adjust the pH of solutions for
injection, and as an adjunct for oral
liquids.

10. Description:
 white to light-yellow-colored, non hygroscopic,
odorless, crystalline powder, acidic taste.
Stability and Storage Conditions:
 stable in air, stored in a well-closed nonmetallic
container, protected from light, in a cool, dry
place.
Incompatibilities:
 Incompatible with alkalis, heavy metal ions,
oxidizing materials, sodium nitrite, sodium
salicylate, theobromine salicylate.
Safety:
 The body can absorb about 500 mg of
ascorbic acid daily.
 Large doses may cause diarrhea or
other gastrointestinal disturbances.
 Damage to the teeth has also been
reported.
Handling Precautions:
 Observe normal precautions
appropriate to the circumstances and
quantity of material handled.

11. Ascorbyl Palmitate
Synonyms:
L-Ascorbic acid 6-palmitate; ascorbylis
palmitas;
E304; vitamin C palmitate.
Chemical Name:
L-Ascorbic acid 6-hexadecanoate
Structure:
Functional Category:
Antioxidant.
Applications:
 used as a stabilizer for oils in oral
pharmaceutical formulation generally
0.05% w/v is used.
 used in oral and topical preparations
as an antioxidant for drugs unstable
to oxygen.

12. Description:
Ascorbyl palmitate is a practically odorless,
white to yellowish Powder
Stability and Storage Conditions:
 stable in the dry state, becomes
discolored when exposed to light and
high humidity.
 stored in a cool place, it has a shelf life
of at least 12 months.
Incompatibilities:
 oxidizing agents
Safety:
 used as an essentially nontoxic and nonirritant
material.
 daily intake for ascorbyl palmitate at up to 1.25
mg/kg bodyweight.
Handling Precautions:
 Observe normal precautions appropriate to the
circumstances and quantity of material handled.
 Ascorbyl palmitate dust may cause irritation to
the eyes.

13. Aspartame
Synonyms:
APM; aspartamum; Pal Sweet; Pal
Sweet Diet; Tri-Sweet.
3. Chemical Name:
N-L-a-Aspartyl-L-phenylalanine 1-
methyl ester
Structural Formula:
Functional Category:
Sweetening agent.
Applications:
 table-top sweetners in pharmaceutical preparations
including tablets, and vitamin preparations.
 used to mask some unpleasant taste characteristics
 sweetening power is 180–200 times that of
sucrose.
Description:
 off white, almost odorless crystalline powder.

14. Stability and Storage Conditions:
 Aspartame is stable in dry
conditions.
 stored in a well-closed container, in a
cool, dry place.
Incompatibilities:
 with dibasic calcium phosphate and
also with the lubricant magnesium
stearate.
Safety:
 used as an intense sweetener, and as
a nontoxic material.
 intake restricted by those persons
with phenylketonuria.
 daily intake for aspartame at up to
40mg/kg body weight.
Handling Precautions:
 Eye protection is recommended.
Aspartame

15. Attapulgite
Synonyms:
Actapulgite; Attaclay; Attacote;
Attagel; attapulgus; palygorscite.
Functional Category:
Adsorbent.
Stability and Storage Conditions:
 adsorb water.
 stored in an airtight container in a
cool, dry, location.
Applications:
 used as an adsorbent in solid dosage
forms.
 concentrations of 2–5% w/v usually
form oil-in-water emulsions.
 used therapeutically as an adjunct in
the management of diarrhea.

16. Safety:
 used as an essentially nontoxic and nonirritant
material.
 up to 9 g is used in daily divided doses as an
adjunct in the management of diarrhea.
Handling Precautions:
 Eye protection, gloves, and a dust mask are
recommended.
 handled in a wellventilated environment and
dust generation should be minimized.
Description:
 light cream colored, very fine
powder.
Incompatibilities:
 decrease the bioavailability of
loperamide and riboflavin.
 Oxidation of hydrocortisone is
increased in the presence of
attapulgite.
Attapulgite

17. Bentonite
Synonyms:
Albagel; bentonitum; E558; mineral
soap; Polargel; soap clay; taylorite;
Veegum HS.
Structural Formula:
Applications:
 Therapeutically, bentonite has been
investigated as an adsorbent for lithium
poisoning.
Uses of bentonite:
Adsorbent (clarifying agent) =1.0–2.0%
Emulsion stabilizer= 1.0%
Suspending agent=0.5–5.0%

18. Functional Category
Adsorbent; stabilizing agent;
suspending agent; viscosity increasing
agent
Description:
 crystalline, claylike mineral, odorless,
cream to grayish-colored fine powder
 have a slight earthy taste.
Stability and Storage Conditions:
 Hygroscopic
 sorption of atmospheric water
should be avoided.
 stored in an airtight container in a
cool, dry place.
Bentonite

19. Incompatibilities:
 The addition of alkaline materials, such as magnesium oxide, increases gel formation.
 incompatible with strong electrolytes, acriflavine hydrochloride.
Safety:
 not absorbed from the gastrointestinal tract.
 regarded as a nontoxic and nonirritant material.
Handling Precautions:
 Eye protection, gloves, and a dust mask are recommended.
 handled in a wellventilated environment and dust generation minimized.

20. SL no. Ingredient name Uses Amount in mg Conc.%
1. Ascorbic acid(Vitamin
C)
Active ingredient 500 33.33
2. Pyridoxine Active ingredient 20 1.33
3. PVP Binder 45 3
4. sucrose Filler, sweeting
agent
225 15
5. Citric Acid
Monohydrate
Acidifying agent 208 13.87
6. Tartaric Acid Acidifying agent 222.9 14.86
7. Sodium Bicarbonate Alkalizing agent 249.5 16.63
8. PEG 8000 Lubricant 30 2
FORMULATION
Formula for 1 piece 1500mg of Vitamin C effervescent tablets:

21. Thank you