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Drug Discovery and Development Assignment 1

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25 views5 pages

Drug Discovery and Development Assignment 1

Uploaded by

TANMAY AGARWAL
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Drug Discovery and Development

[CSU849]

Submitted to:
Sonia Rani
Faculty of Pharmaceutical Sciences,
Shoolini University.

Submitted by:
Tanmay Agarwal
GF202349784
B.Sc. Biotechnology
III Semester
(2023-2027)
Introduction to Dosage Forms
A dosage form is the physical form of a drug or medication that is designed to deliver the
therapeutic agent to a patient effectively and safely. It determines the route of administration,
pharmacokinetic behaviour, and bioavailability of the drug. The design of dosage forms is a
critical aspect of pharmaceutical science because it impacts the effectiveness and patient
compliance.

 Factors Influencing the Choice of Dosage Form

1. Drug Properties: Solubility, stability, and absorption characteristics of the active


ingredient.
2. Patient Factors: Age, condition, and ability to administer or tolerate certain types of
medications (e.g., swallowing difficulties may require liquid formulations).
3. Disease State: The condition being treated may dictate specific routes of
administration for faster action (e.g., asthma may require inhalers).
4. Dosage Accuracy: Some forms provide precise dosing (e.g., tablets), while others,
like creams, offer flexibility in dose adjustments.

 Types of Dosage Forms:

A. Solid Dosage Forms:


1. Tablets: Available in various types like chewable, effervescent, extended-release, or
sublingual tablets. Tablets are designed to disintegrate in the stomach or other parts of
the gastrointestinal tract.
2. Capsules: Gelatin-based containers that hold either liquid or solid drug formulations.
They can be enteric-coated to protect the drug from being destroyed by stomach acids.
3. Powders: Often used in cases where patients need to mix the drug with water before
ingestion (e.g., antacids). Powders can also be used for external applications like
topical antibiotics.
4. Granules: Prepared agglomerates of powders used for reconstitution into liquids,
often seen in paediatric formulations.

B. Liquid Dosage Forms:

1. Solutions: The active drug is dissolved in a solvent, providing rapid absorption.


Commonly used for oral, intravenous (IV), or topical applications.
2. Suspensions: Useful for drugs that are insoluble in water; the drug particles are
suspended in a liquid medium and require shaking before use. They are common in
pediatric and topical medications.
3. Syrups: Viscous liquid preparations containing a high concentration of sugar, often
used to improve the taste of oral medications.
4. Elixirs: Alcohol-based solutions used to dissolve drugs that are insoluble in water.
C. Semi-Solid Dosage Forms:

1. Creams: Semi-solid emulsions that are used for topical administration. They are
easier to spread and are used for conditions like skin irritations or infections.
2. Ointments: Greasy formulations that are more occlusive, providing a barrier over the
skin to retain moisture and deliver the drug.
3. Gels: Semi-solid systems containing either small or large molecules that are dispersed
in a liquid but solidified by a gelling agent. Gels offer a cooling effect when applied to
the skin.

D. Other Dosage Forms:


1. Transdermal Patches: A patch that delivers a specific dose of medication through the
skin into the bloodstream. They provide controlled release over an extended period
(e.g., nicotine patches).
2. Inhalers and Nebulizers: Used to administer drugs via the respiratory system,
typically for conditions such as asthma or chronic obstructive pulmonary disease
(COPD). Nebulizers convert liquid medication into mist for easy inhalation.
3. Suppositories: Solid forms that melt or dissolve inside the body when inserted into
the rectum, vagina, or urethra. They bypass the gastrointestinal tract and provide
localized or systemic effects.

 Applications of Dosage Forms:

1. Oral Route: Oral dosage forms like tablets, capsules, and liquids are convenient and
preferred for non-invasive administration. However, they may not be suitable for
drugs that are inactivated by stomach acid or for patients with gastrointestinal
absorption issues.
2. Topical Route: Creams, ointments, gels, and patches are used for localized treatment
of skin conditions, pain relief, or hormone replacement therapy.
3. Parenteral Route: Injections, including intravenous, intramuscular, and subcutaneous
forms, provide rapid onset of action and are used for drugs that are poorly absorbed
orally.
4. Inhalation Route: For respiratory conditions, this route delivers medication directly
to the lungs, providing a fast response in conditions like asthma or COPD.
5. Rectal/Vaginal Route: These forms are useful when oral administration is not
feasible due to vomiting, or when local treatment is required (e.g., for hemarhoids or
infections).

Introduction to Intellectual Property Rights (IPR)


Intellectual Property Rights (IPR) provide legal protection for the creators of intellectual
property, allowing them to control the use and distribution of their inventions, works, or
symbols. These rights are crucial for promoting innovation and creativity, as they give
inventors the incentive to develop new products, knowing they will be legally protected.
 Importance of IPR in Biotechnology and Pharmaceuticals:
In the fields of biotechnology and pharmaceuticals, IPR plays a critical role in protecting
innovations related to drug formulations, medical devices, and diagnostic tools. Patents, in
particular, encourage pharmaceutical companies to invest in the research and development of
new drugs by providing exclusive rights to market them for a specific period. Without this
protection, competitors could easily replicate and sell the same product, disincentivizing
innovation.

 Types of IPR:
I. Patents:
A patent provides the patent holder with the exclusive right to make, use, sell, or
distribute an invention for a specified period, typically 20 years from the filing date.
To be patentable, an invention must be novel, non-obvious, and useful. Patents are
especially critical in the pharmaceutical industry, where they protect the development
of new drugs and treatments.
1. Pharmaceutical Patents: These include patents for new chemical entities,
formulations, drug delivery systems, and methods of manufacturing.
2. Biotechnology Patents: These cover genetic modifications, biotechnological
processes, and new organisms or cell lines.
II. Trademarks:
Trademarks protect brand names, logos, slogans, and symbols that identify products
or services. In the pharmaceutical industry, trademarks are vital for ensuring the
distinctiveness of drug names and preventing confusion between similar products.
Example: Brand names like "Tylenol" or "Aspirin" are trademarked, distinguishing
them from generic equivalents.
III. Copyrights:
Copyright protects creative works such as literary, artistic, or musical works. In the
pharmaceutical context, it could apply to instructional manuals, software for drug
discovery, or educational materials for healthcare providers.
IV. Trade Secrets:
Trade secrets involve confidential information that provides a competitive advantage.
For instance, the formula for Coca-Cola is a famous trade secret. In the
pharmaceutical industry, trade secrets could include formulations, manufacturing
processes, or clinical trial data that a company wants to keep proprietary.
Example: Formulation techniques or specific processes used in drug manufacturing
can be protected as trade secrets rather than filing for patents.
V. Geographical Indications (GI):
GI is a sign used on products that have a specific geographical origin and possess
qualities or a reputation due to that origin. While not directly related to pharmaceuticals,
GIs are more common in the food and beverage industry (e.g., Champagne, Roquefort
cheese). However, it could apply to medicinal plants grown in specific regions.

Applications and Importance of IPR:

1. Encouragement of Innovation: IPR incentivizes individuals and organizations to


innovate by ensuring they can reap the benefits of their research and development
efforts.
2. Protection Against Infringement: It provides legal mechanisms to prevent others
from copying or using an invention or creative work without permission.
3. Economic Growth: IPR helps in fostering economic growth by encouraging
investment in research, development, and innovation. Patents, in particular, play a
vital role in biotechnology and pharmaceuticals, where development costs are high,
and the payoff may take years to realize.
4. Global Recognition: IPR provides a framework for international trade, allowing
inventors and creators to protect their works and innovations across borders.

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