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Inorganic Pharmaceuticals 87
2. Magnesium Hydroxide I.P. Syrup with Aluminium Hydroxide Gel and Simethicone
Ingredient with quantity:
Magnesium hydroxide I.P. – 150 mg
Dried aluminium hydroxide gel – 150 mg
Simethicone – 125 mg
Oxetacaine – 10 mg
Excipients – q.s.
Marketed Preparations:
1. Ancool Sugar Free Suspension Syrup – 170 ml
Brand: Ancool
Company: Zuventus
Each 5 ml of syrup contains: aluminium hydroxide 300 mg + magnesium hydroxide 150
mg + oxetacaine 10 mg + simethicone 125 mg
Composition
Aluminium hydroxide
300 mg
Magnesium hydroxide
150 mg
Oxetacaine
10 mg
Simethicone
125 mg
2. Gelovib/Gelogem Syrup – 170 ml
Brand: Gelovib
Company: Vibcare Pharma
Composition
Magnesium Hydroxide
250 mg
Dried Aluminium Hydroxide Gel
250 mg
Simethicone
50 mg
Sorbitol
1.25 mg
3.2.3 Magaldrate
Chemical Formula: Al
5
Mg
10
(OH)
31
(SO
4
)
2
· x H
2
O
Molecular Weight: 1097.38 gm/mol
Brand Name: Riopan (Whitehall-Robins)
Synonym: Aluminium Magnesium Hydroxide Sulfate
88 Text Book of Pharmaceutical Chemistry
It contains the equivalent of not less than 90.0% and not more than 105.0% of
Al
5
Mg
10
(OH)
31
(SO
4
)
2
, calculated on the dried basis.
Properties: Magaldrate occurs as white or almost white, crystalline powder. It is practically
insoluble in water and ethanol (96%); and soluble in dilute mineral acids.
Preparation of Magaldrate: Magaldrate is prepared by the reaction of active aluminum
hydroxide with a water soluble, sulfate containing compound and active magnesium oxide and/or
magnesium hydroxide in stoichiometric quantities in the presence of water.
Uses: The list of uses of Magnesium hydroxide is given below:
➢ It is used to treat heartburn, sour stomach and acid indigestion.
➢ It is used in hyperphosphatemia and magnesium deficiency.
➢ Magaldrate is used off-label to treat gastric and duodenal ulcers gastroesophageal reflux
disease (GERD).
Storage: Magaldrate is tablet stored at room temperature between 59°F and 86°F (15°C to 30°C)
away from heat and light. The liquid form of this medication (oral suspension) may be stored in
the refrigerator to improve taste.
Pharmaceutical Formulations: Magaldrate is available in the form of oral suspension or tablets.
Oral Suspension: 540 mg/5 ml; Tablet: 400 mg
1. Riopan Plus Suspension:
Magaldrate (96 mg/mL) + Dimethicone (4 mg/mL)
2. Asidopan Plus 30 Cigneme Tablet:
Magaldrate (480 mg) + Simethicone (20 mg)
3. Riopan Suspension:
480 mg/5 ml
Marketed Preparations of Magaldrate:
Brand Name
Dosage Form
Company
Domgel
Suspension
Magaldrate Simethicone Suspension 170 ml
Magaldrate (480 mg) + Simethhicone (20 mg) +
Domperidone (10 mg)
Dexter Formulations Pvt.
Ltd.
Petcool
Magaldrate and Simeticone Suspension 170 ml
Magaldrate (400 mg) + Simethicone (20 mg)
Medheal Pharmaceuticals
3.2.4 Sodium Bicarbonate
Chemical Formula: NaHCO
3
Molecular Weight: 84.007 g/mol
Brand Name: Neut
Synonym: Baking soda or bicarbonate of soda
Inorganic Pharmaceuticals 89
Sodium bicarbonate is a salt composed of a sodium cation (Na
+
) and a bicarbonate anion
(HCO
3
−
). It contains not less than 99.0% and not more than 100.5% w/w of NaHCO
3
calculated
on a dry basis.
Preparation of Sodium Bicarbonate: Sodium bicarbonate is mainly produced by the Solvay
process. In this process, ammonia, carbon dioxide, water and brine solution in its concentrated
form are used as raw materials. The ammonia and carbon dioxide react to form ammonium
bicarbonate that is allowed to react with NaCl to precipitate sodium bicarbonate.
NH
3
+ H
2
O + CO
2
→ NH
4
HCO
3
NH
4
HCO
3
+ NaCl → NaHCO
3
+ NH
4
Cl
Then, pure sodium bicarbonate can be produced by covering sodium carbonate crystal with water
and passing in carbon dioxide.
Na
2
CO
3
+ CO
2
+ H
2
O → 2NaHCO
3
Properties of Sodium Bicarbonate: Sodium bicarbonate occurs as a white, crystalline powder
that sometimes forms lumps. It is odorless and has a bitter, salty taste. It is soluble in water and
insoluble in ethyl alcohol, and has a melting point of 50°C. It is stable in dry air, but slowly
decomposes in moist air. Its solutions, when freshly prepared with cold water, without shaking,
are alkaline to litmus. The alkalinity increases as the solutions stand, are agitated or are heated.
Uses: The list of uses of Sodium bicarbonate is given below:
➢ Used as an antacid to treat stomach upset and indigestion.
➢ Sodium bicarbonate is used in a condition of urinary alkalinization to produce urine with
a pH > or = 7.5.
➢ Treatment of metabolic acidosis associated with many conditions including severe renal
disease (e.g., renal tubular acidosis).
➢ It acts as a pesticide.
➢ It is used in ear drops, cosmetics and personal care products.
➢ It is used to treat long-term stomach acid problems (such as peptic ulcer disease, GERD,
etc.).
➢ Baking soda may help freshen a smelly fridge by neutralizing bad odors.
➢ It is a safe alternative to commercial air fresheners, as it is free of industrial
chemicals and neutralizes odor particles.
➢ It is used in uncontrolled diabetes, circulatory insufficiency due to shock or severe
dehydration.
➢ It is used in the process of washing as a water softener.
➢ Baking soda is an alternative to commercial silver polishers.
➢ It is used in baking industries as carbon dioxide is generated (due to the decomposition of
NaHCO
3
) which helps in the raising of the dough.
90 Text Book of Pharmaceutical Chemistry
Pharmaceutical Formulations: Sodium Bicarbonate is available in the following formulations:
➢ Injectable solution: (4%, 4.2%, 7.5%, 8.4%)
➢ Tablet: (325 mg, 650 mg)
➢ Suspension: (1000 mg/15 ml, 133.5 mg/5 ml).
1. Sodium Bicarbonate Oral Suspension 1000 mg
➢ Sodium Bicarbonate I.P. – 1000 mg
➢ Flavored syrup base – q.s.
➢ Coloring agent – q.s.
2. Sodium Bicarbonate, Sodium Alginate and Calcium Carbonate Suspension 150 ml
➢ Sodium Bicarbonate – 133.5 mg
➢ Sodium alginate – 250 mg
➢ Calcium carbonate I.P. – 80 mg
➢ Light kaolin – 1 g
➢ Mint flavor – q.s.
➢ Water – Upto 5 ml
3. Sodium Bicarbonate USP 500 mg tablet
➢ Sodium Bicarbonate USP – 500 mg
➢ Excepients – q.s.
Marketed Preparations of Sodium Bicarbonate:
Brand Name
Dosage Form
Company
Sobisis Forte
Sodium Bicarbonate Tablet USP
Ocean Pharmaceutical
Gavita
Sodium Bicarbonate Tablet 500 mg
Trifecta Pharma Co. Ltd.
Gaviscon
Sodium Alginate, Sodium Bicarbonate
and Calcium Carbonate
Reckitt Benckiser
Storage Condition: Sodium bicarbonate should be stored in a well tightly closed container and
placed in a well-ventilated, cool and dry area. Keep away from acids, excessive heat and
moisture.
3.2.5 Calcium Carbonate
Chemical Formula: CaCO
3
Molecular Weight: 100.09
Brand Name: Calci-Chew
Synonym: Calcite, Aragonite, Vaterite, Chalk
Inorganic Pharmaceuticals 91
Calcium Carbonate contains not less than 98.0% and not more than 100.5% w/w of calcium
carbonate calculated with reference to the dried substance. It is the carbonic salt of calcium
(CaCO
3
).
Preparation of Calcium Carbonate (CaCO
3
): CaCO
3
is prepared by using carbon dioxide and
calcium hydroxide (slaked lime) as raw materials. When carbon dioxide is passed through slaked
lime, calcite is obtained.
Ca(OH)
2
+ CO
2
→ CaCO
3
+ H
2
O
Carbon dioxide helps in the production of calcium hydrogen carbonate when it passes in bulk.
It is also prepared by another method by mixing, boiling calcium chloride and sodium carbonate
solution and allowing the resulting precipitate to settle.
CaCl
2
+ Na
2
CO
3
→ CaCO
3
+ 2NaCl
Properties: Calcium carbonate appears as white, fluffy odorless powder or colorless crystals. It is
practically insoluble in water and stable at normal temperatures. It is used in the manufacture of
quick lime and as a building material in the form of marble. It has a density of 2.71 g/ml and
melting point of 1,339°C as its calcite form. When calcium carbonate is heated at 1200 K, it
decomposes to evolve carbon dioxide.
CaCO
3
→ CaO + CO
2
Calcium carbonate occurs naturally in several mineral forms including the pure calcite, aragonite
and vaterite minerals as well as the impure minerals – limestone, chalk, marble and travertine. It
is also the main chemical constituent of eggshells, sea shells, oyster shells, snail shells, corals, etc.
The other common mineral form, aragonite, has a density of 2.83 g/ml and melting point of
825°C.
Uses: The list of uses of calcium carbonate is given below.
Medicinal and Pharmaceutical Uses of Calcium Carbonate:
➢ It is used to prevent or treat low blood calcium levels.
➢ It is used to treat conditions caused by low calcium levels such as bone loss
(osteoporosis), weak bones (osteomalacia/rickets), etc.
➢ It is used in medicinal industries which manufacture antacids, tablets which are made of
base materials, etc.
➢ It is also used as a food preservative and in toothpastes.
➢ Decreased activity of the parathyroid gland (hypoparathyroidism).
Uses of Calcium Carbonate:
➢ Calcium carbonate plays an important role in construction, be it as a building material
(marble) or as an ingredient in cement.
➢ It is used in the manufacture of paints, paper, plastics, etc.
92 Text Book of Pharmaceutical Chemistry
➢ It is used in the manufacture of ceramic tiles, blackboard chalk, and iron ore purification,
oil well drilling fluids, paints, adhesives, and sealants.
➢ Calcium carbonate is used as an additive to food products for livestock animals and
humans, and as a supplement in vitamins.
➢ Application of calcium carbonate is done in fertilizers to provide calcium to plants and
pH stabilization of the soil.
➢ Calcium carbonate is largely employed in the pulp and paper industry.
➢ It can be used as a filter and pigment, making possible the production of a whiter, higher
quality pigment than other minerals.
Pharmaceutical Formulations: Calcium carbonate is available in the following formulations:
➢ Oral suspension 1250 mg/5 ml (elemental calcium 500 mg per 5 ml),
➢ Oral tablet (500 mg, 600 mg, 648 mg)
➢ Oral tablet, chewable (1000 mg, 1177 mg, 400 mg, 420 mg, 500 mg, 550 mg, 600 mg,
750 mg, 850 mg, base 500 mg)
➢ Powder (OTC): 800 mg/2 g (480 g).
1. Calcium Carbonate, Sodium Bicarbonate, Sodium Alginate Suspension 150 ml
➢ Calcium carbonate I.P. – 80 mg
➢ Sodium bicarbonate – 133.5 mg
➢ Sodium alginate – 250 mg
➢ Light kaolin – 1 mg
➢ Mint flavor – q.s.
➢ Water – Upto 5 ml
2. Calcium Carbonate I.P. 250 mg
➢ Calcium carbonate I.P. – 250 mg
➢ Excipients – q.s.
3. Calcium Carbonate I.P. 500 mg
➢ Calcium carbonate I.P. – 500 mg
➢ Excipients – q.s.
Marketed Preparations of Calcium Carbonate:
Brand Name
Dosage Form
Company
Ciancal 500 mg
Calcium Carbonate 1250 mg + Vitamin D
3
250 IU
Tablets
Cian
Calcitol 500 mg
Calcitrol 500 Calcium Carbonate + Vitamin D
3
Ambe Pharma
Califid
Calcium Carbonate, Vitamin D
3
, Zinc and
Magnesium Suspension
Aelida Healthcare
Inorganic Pharmaceuticals 93
Storage Conditions: Store in a cool, dry place, store material tightly sealed in properly labeled
containers. Protect from moisture.
3.2.6 Acidifying Agents
Empty stomach has pH 1.5-2 and it raises (pH 5-6) after ingestion of food pH 5-6. The pH of
stomach is so low because of the secretion of HCl. Gastric HCl destroys the bacteria of the
ingested food and drinks. It also softens the fibrous food and helps in formation of the proteolytic
enzyme pepsin and metabolism of proteins in the ingested food.
Achlorhydria and Hypochlorhydria
Consequently, absence of hydrochloric acid (HCl) in the gastric juices can cause
achlorhydria. It is a more severe form of a hypochlorhydria, a deficiency of stomach acids. Both
the conditions can impair the digestive process and lead to damage of the gastrointestinal
system. There are various factors which are responsible for developing achlorhydria, including:
hypothyroidism, Surgery, H. pylori infection, autoimmune disorders and medications.
Acidifying agents are the chemicals that increase the level of gastric acid in the stomach
when ingested, thus decreasing the stomach pH. These agents are used in condition where there is
absence or insufficient secretion of hydrochloric acid in stomach and leads to the conditions
called achlorhydria or hypochlorhydria. These disease states can be treated by various acidifying
agents like ammonium chloride, dilute HCl, Calcium chloride, etc.
There are four main types of acidifiers:
➢ Gastric acidifiers, used to restore temporarily the acidity of stomach in patient suffering
from hypochlorhydria.
➢ Urinary acidifiers, used to control pH in urine.
➢ Systemic acidifiers, used to control pH in the overall body.
➢ Acids, mostly used in laboratory experiments.
Dilute Hydrochloric Acid
Chemical Formula: HCl
Molecular Weight: 36.5
IP Limit: It contains not less than 9.5% and not more than 10.5% w/w of HCl
Preparation: It is prepared by mixing of HCl and purified water.
Measure 137 ml of Hydrochloric acid and transferred in a beaker. Pour about 200 ml of distilled
water into a 500 ml capacity beaker. Transfer slowly, through sidewalls of the beaker, 137 ml of
Hydrochloric acid LR, into above said beaker, while gentle mixing by using a glass rod. Transfer
prepared solution into a 500 ml capacity volumetric flask by using a glass funnel. Rinse the
beakers and funnel with few ml of distilled water, and allow to add into the contents of volumetric
flask. Make up the volumetric flask to mark with distilled water, remove the funnel, keep the lid
to close the volumetric flask and shake gently to mix the solution. Transfer the prepared solution
into a suitable container. The resultant solution is having the concentration of 10% w/w.
94 Text Book of Pharmaceutical Chemistry
Properties of Hydrogen Chloride: Hydrochloric acid is strongly acidic, colorless and viscous,
fuming liquid having an irritating odor. It is corrosive and has a distinctively pungent smell. It
liquefies at 189K to form a colorless liquid and freezes at 159K to form a white solid. The
physical properties such as density, melting point, pH and boiling point depend on
the molarities or concentration of HCl.
Uses of Hydrochloric Acid:
➢ HCl is used in the preparation of chlorine, aqua regia, and other chlorides.
➢ Hydrochloric acid is used as a chemical reagent in the large-scale production of vinyl
chloride for PVC plastic and MDI/TDI for polyurethane.
➢ It is used in household cleaning, production of gelatin and other food additives, descaling,
and leather processing.
➢ It is used as a solvent to dissolve noble gases.
➢ It is used in the production of fertilizers.
➢ It is used in textile industries.
➢ It is used in the manufacture of dye.
➢ It is used in the refining of metals.
Test for Identification: To acidified solution, add silver nitrate solution, shake and allow to
stand, curdy white precipitate is formed, which is insoluble in HNO
3
but soluble after being
washed with water in ammonium hydroxide from which it is reprecipitated by the addition of
HNO
3
.
When added to KMnO
4
with dilute nitric acid, chlorine is evolved.
3.2.7 Protectives and Adsorbents
Adsorbents are the substance on which adsorbate is adsorbed, and adsorbate is the material
that has been or can be adsorbed. Adsorption is defined as the adhesion of atoms, ions, or
molecules from a gas, liquid, or dissolved solid to a surface. Major types of adsorbents in use are:
activated alumina, silica gel, activated carbon, molecular sieve carbon, molecular sieve zeolites
and polymeric adsorbents. Most adsorbents are manufactured (such as activated carbons), but a
few, such as some zeolites, occur naturally. In the process of adsorption, the gas or liquid particles
bind to the solid or liquid surface which is called as adsorbent. The particles form an atomic or
molecular adsorbate film.
Various adsorbent materials such as carbon, silica gels and alumina are amorphous, and have
complex network of interconnected micropores.
Inorganic Pharmaceuticals 95
Applications of Various Commercial Adsorbents
Adsorbent
Application
Zeolites
• Purification of hydrogen
• Separation of ammonia and hydrogen
• Recovery of carbon dioxide
• Separation of oxygen and argon
• Removal of acetylene, propane and butane from air
• Separation of xylenes and ethyl benzene
• Separation of normal from branched paraffins
• Separation of olefins and aromatics from paraffins
• Drying of gases
• Removing water from azeotropes
• Sweetening sour gases and liquids
Activated Alumina
• Removal of HCl from hydrogen
• Drying of gases, organic solvents, transformer oils
• Removal of fluorine in alkylation process
Carbons
• Nitrogen from air
• Hydrogen from syn gas
• Removal of odors from gases
• Recovery of solvent vapors
• Purification of helium
• Clean-up of nuclear off-gases
• Water purification
Polymers and Resins
• Recovery of proteins and enzymes
• Removal of colors from syrups
• Removal of organics from hydrogen peroxide
• Water purification
Silica Gels
• Drying of gases, refrigerants and organic solvents
• Desiccants in packing
3.2.8 Cathartics
Saline Cathartics (purgative) are inorganic agents that promote evacuation of bowels, used in
constipation and dyschezia (the inability to defecate without pain or difficulty). These agents help
to resolve constipation or empty the bowel of fecal matter before procedures or surgery involving
the lower bowel. Increase the motility of the intestine or increase the bulk of feces. Constipation
is generally defined as “the passage of hard stools less frequently than the person’s normal bowel
pattern”. Constipation is of two different types:
96 Text Book of Pharmaceutical Chemistry
➢ Primary constipation: Primary constipation often associated with not consuming
enough fiber or not drinking enough fluids, causes slow intestinal movements.
➢ Secondary constipation: This type of constipation is caused by some metabolic disease
such as diabetes, neurologic diseases (stroke, Parkinson’s disease, multiple sclerosis),
connective tissue disorders, or eating disorders.
3.2.9 Laxatives
Laxatives are types of drugs that are used to treat constipation by loosening stools or inducing
a bowel movement. Laxatives usually should not be used for long-term unless under medical
supervision because they can cause electrolyte disturbances, and make the patient dependent on
laxatives. Laxatives come in the form of pills, capsules, and liquids, suppositories and enemas. They
are divided into five categories:
1. Bulk-forming Laxatives: These laxatives increase the water content and bulk of the
stool, making it move more easily through the intestinal tract. They take 2 or 3 days to
work. These types of laxatives include natural and semi-synthetic polysaccharide and
cellular derivatives, e.g., psyllium (Metamucil), methylcellulose (Citrucel), and high-
fiber foods such as fruits, vegetables and whole grains. These absorb water in the bowel
and swell to bulk out the stool making it softer and easier to pass.
2. Lubricant Laxatives: These agents, as the name indicate, make stool slippery. So, it
moves through the intestine more easily and quickly. The mineral oil and vegetable oil
within these drugs adds a slick layer to the intestine’s walls and stops the stool from drying
out. These drugs typically take 6 to 8 hours to work.
3. Emollient Laxatives (Stool Softeners): These agents moisten and lubricate the
stool making it easier to pass. An emollient laxative includes Colace contain
decussate, a surfactant that helps to "wet" and soften the stool.
4. Stimulant Laxatives: These agents promote contraction of the intestines, promoting the
movement of stools through the bowel. These drugs also increase a stool’s hydration.
Examples of stimulant laxatives are bisacodyl (Correctol, Dulcolax, Feen-a-Mint),
and sennosides (e.g., Lax, Senokot).
5. Osmotic Laxatives: These agents draw fluids into the intestine from the surrounding
tissues, making stool softer and easier to pass. These products include Fleet Phospho-
Soda, lucatose (Kristalose), magnesium hydroxide (Milk of Magnesia or MOM), lactitol
(Pizensy), and polyethylene glycol (Miralax).
3.3 TOPICAL AGENTS
A topical drug is one that is applied to the skin, mucus membranes, or in the body cavities to
have a local effect. Topical refers to something that is relevant to a specific location or area, or
simply “local”. For example, lotions, creams and ointments are applied topically on the skin. Eye
drops are instilled directly into the eyes. These include antibiotics, antiseptic, corticosteroids,
antineoplastics, local anesthetics, etc.