Pharmaceutics is one of the most scoring subjects in D. Pharmacy if concepts are understood clearly. In this article, pharmaceutics important questions are explained in simple language for MSBTE, AKTU, BTEUP, RUHS and other state boards.
1) Define Pharmacopoeia and explain Indian Pharmacopoeia in detail
A pharmacopoeia is an official and legally recognized reference book that lays down standards for the identity, purity, strength, and quality of drugs and pharmaceutical substances. These standards are compulsory and must be followed by drug manufacturers, quality control laboratories, and regulatory authorities to ensure that medicines supplied to patients are safe, effective, and of uniform quality.
Unlike textbooks, pharmacopoeias have legal authority. If a drug does not comply with pharmacopoeial standards, it can be declared substandard or adulterated, and regulatory action may be taken against the manufacturer. Therefore, pharmacopoeias play a crucial role in drug regulation and public health protection.
Etymology of Pharmacopoeia
The term pharmacopoeia is derived from Greek words: Pharmakon – meaning drug and Poiein – meaning to make. Together, the term indicates the preparation and standardization of medicines.
Indian Pharmacopoeia (IP): The Indian Pharmacopoeia (IP) is the official pharmacopoeia of India. It is published by the Indian Pharmacopoeia Commission (IPC) under the Ministry of Health and Family Welfare, Government of India. The headquarters of IPC is located in Ghaziabad, Uttar Pradesh. The Indian Pharmacopoeia is written in English and serves as the legal standard for drugs manufactured, sold, and distributed in India.
The IP contains monographs of drug substances, dosage forms, excipients, pharmaceutical aids, and biological products. It also includes general chapters related to analytical methods, tests, and procedures used in quality control laboratories.
Editions of Indian Pharmacopoeia: The Indian Pharmacopoeia has been revised periodically to include new drugs, remove obsolete substances, and update analytical techniques in line with scientific advancements.
1st Edition (1955): First official pharmacopoeia of independent India; work began in 1946.
2nd Edition (1966): Several outdated monographs were removed and new ones added.
3rd Edition (1985): Published in two volumes, reflecting growth in pharmaceutical science.
4th Edition (1996): Expanded content with improved standards.
5th Edition (2007): Introduced herbal medicines and biotechnology products.
6th Edition (2010): Published in three volumes with updated general chapters.
7th Edition (2014): Included a large number of new monographs.
8th Edition (2017): Became effective from 2018 with additional monographs.
Each new edition improves drug quality standards and aligns Indian regulations with global practices.
2) Define packaging and classify packaging materials used in pharmacy
Packaging is the process by which pharmaceutical products are enclosed, protected, and labeled so that they retain their therapeutic effectiveness, safety, and quality throughout their shelf life. A pharmaceutical package may or may not be in direct contact with the drug product, but it plays a vital role in protecting the formulation from environmental and mechanical damage.
In pharmacy, packaging is not only meant for containment but also for protection, identification, information, and convenience.
Classification of pharmaceutical packaging: Pharmaceutical packaging is broadly classified into three types based on its level of protection and function.
1. Primary packaging: Primary packaging consists of materials that are in direct contact with the drug formulation. It provides the first line of protection against moisture, light, air, microorganisms, and physical damage. The compatibility of primary packaging materials with the drug is extremely important to prevent chemical interaction or contamination.
Examples: Glass bottles, plastic containers, blister packs, strip packs, ampoules, and vials.
2. Secondary packaging: Secondary packaging surrounds the primary package and provides additional protection. It also carries essential information such as drug name, dosage, storage conditions, manufacturer details, batch number, and expiry date.
Examples: Cartons, boxes, labels, package inserts, leaflets, and shrink wraps.
3. Tertiary packaging: Tertiary packaging is used for bulk handling, storage, and transportation of pharmaceutical products. It does not come in contact with the drug product directly but ensures safe movement during distribution.
Examples: Large cardboard boxes, barrels, containers, pallets, and crates.
Proper selection of packaging materials is essential to maintain drug stability, ensure patient safety, and comply with regulatory requirements.
3) Hammer Mill and Ball Mill
Hammer Mill
A hammer mill works on the principle of impact. In its construction, it consists of a metal casing that encloses a central rotating shaft. Several swinging hammers are attached to this shaft, and a screen is provided at the bottom. The shaft is driven by an electric motor operating at high speed.
During working, the material is fed through a hopper. The rapidly rotating hammers strike the material and break it into smaller particles. The fine particles pass through the screen, while larger particles remain inside until further reduced.
Hammer mills are commonly used for crushing fibrous materials and for size reduction of brittle drugs. They are also useful for powdering leaves, roots, and barks.
Ball Mill
A ball mill works on the combined principle of impact and attrition.
It consists of a hollow rotating cylindrical shell that is partially filled with steel or rubber balls. The balls occupy about 30–50% of the mill volume.
In operation, the material to be ground and the balls are placed inside the cylinder. When the cylinder rotates at an optimum speed, the balls are lifted and then fall back, striking the material and reducing its size.
Ball mills are mainly used for grinding hard solids, for wet grinding, and for size reduction of brittle and sticky drugs. They are also used in grinding ores.
4) Cyclone Separator
A cyclone separator works on the principle of centrifugal force.
When a fluid containing solid particles enters the cyclone at high velocity, a strong centrifugal force is generated. Due to this force, heavier particles move towards the outer wall while lighter particles remain with the fluid stream.
The cyclone separator consists of a cylindrical vessel with a conical bottom. The fluid enters tangentially near the top, and a central outlet is provided for the exit of clean fluid. The separated solids are collected at the bottom.
|During working, the incoming fluid starts rotating inside the vessel. Fine particles exit with the fluid through the top outlet, whereas heavier particles strike the wall, lose velocity, and fall into the conical base where they are collected.
Cyclone separators are used for separating solids from gases or liquids and for separating coarse particles from fine particles.
5) Double Cone Blender and Triple Roller Mill
Double Cone Blender
A double cone blender works on the principle of tumbling and shear action.
It consists of two cone-shaped vessels joined together and mounted on a rotating shaft. Agitator blades are present inside the vessel, and the entire unit is made of stainless steel.
During operation, the powder is loaded into the blender. As the vessel rotates, the material moves upward along the walls and then falls back due to gravity. This tumbling action, along with shear from the agitator blades, results in uniform mixing.
Double cone blenders are used for mixing powders and granules of different densities. They are also used for dry powder mixing and in cosmetic and pharmaceutical industries.
Triple Roller Mill
A triple roller mill works on the principle of compression and shear.
It consists of three hard rollers that rotate at different speeds. A hopper is provided between the first and second rollers, and a scraper is attached to the third roller.
In working, the material passes between the first and second rollers where initial size reduction occurs. Further smoothing and mixing happen between the second and third rollers due to a smaller gap. The final product is collected using a scraper.
Triple roller mills are widely used in the manufacture of ointments, creams, and pastes, and for mixing powders with ointment bases.
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