SUBMITTED BY :

RAFIULLAH

ROLL # :
PHRM51F21R055

SUBJECT :
PHARMACUETICAL TECHNOLOGY

TOPIC :
POLYMERS

SUBMITTED TO :
DR. RAI SARFRAZ
 Index

Abstract.......................................................................................................................... 3

1. Introduction................................................................................................................. 3

2. Definition of Pharmaceutical Polymers..................................................................... 3

3. Importance of Polymers in Dosage Forms.............................................................. 4

4. Selection Criteria for Polymers in Dosage Forms................................................... 4

4.1. Physicochemical Properties................................................................................. 4
4.2. Biopharmaceutical Considerations....................................................................... 5
4.3. Biological Considerations................................................................................... 5
4.4. Economic and Practical Considerations............................................................ 5
Table 1: Key Selection Criteria for Pharmaceutical Polymers................................ 5

5. Classification of Pharmaceutical Polymers.............................................................. 7

5.1. Classification Based on Source ......................................................................... 7
5.1.1. Natural Polymers .................................................................................... 7
5.1.2. Semi-Synthetic Polymers ........................................................................ 7
5.1.3. Synthetic Polymers ................................................................................. 8
6. Applications of Pharmaceutical Polymers................................................................ 9
Water Soluble synthetic Polymers ........................................................................... 9
Cellulose-Based Polymers ……………………….................................................. 9
Hydrocolloids …………………............................................................................ 10
Water-Insouluble biodegradable polymers ............................................................ 10

7. Recent Advances and Future Perspectives.............................................................. 10

8. Conclusion ............................................................................................................... 10

Appendix: Examples of Commonly Used Polymers and Their Functions.................... 11

9. References.................................................................................................................. 11
Abstract.
The current review article focuses on polymers in pharmaceutical drug delivery of therapeutic
agents. These dosage forms includetablets, patches, tapes, films, semisolids and powders.
Polymers are the backbone of a pharmaceutical drug delivery system as they control the release
of the drug from the device. Biodegradable polymers attract the attention of its use as they can be
degraded to non‐ toxic monomers and most important, a constant rate of drug release can be
achieved from a biodegradable polymer based controlled release device. Natural polymers can be
used as the means of achieving predetermined rates of drug delivery and their physico‐ chemical
characteristics with the ease of availability provide a platform to use it as a polymer for drug
delivery systems. Biodegradable polymers have been widely used in biomedical applications
because of their known biocompatibility and biodegradability. In the biomedical area, polymers
are generally used as implants and are expected to perform long term service. These
improvements contribute to make medical treatment more efficient and to minimize side effects
and other types of inconveniences for patients. The main role of polymer is to protect drug from
physiological environment and prolong release of drug to improve its stability. The drug is
release from polymer by diffusion, degradation and swelling. In addition to this review presents
characteristics and behaviors of plant derived and much adhesive polymers which are currently
used in drug delivery

1. Introduction.
Over recent decades, molecular biology has uncovered the molecular basis of many diseases,
leading to advanced therapies such as recombinant DNA technology and gene therapy. However,
the practical application of these therapies has been limited due to the lack of effective drug
delivery systems that ensure targeted, controlled, and sustained drug release. Polymers have
emerged as essential materials in this field because of their biocompatibility, flexibility, and
ability to be chemically modified. They are widely used in drug delivery systems, tissue
engineering, prosthetics, and biomedical devices. In pharmaceuticals, polymers function as
binders, film coatings, stabilizers, and agents for controlled or sustained drug release.
Biodegradable polymers are particularly valuable as they safely degrade after fulfilling their role.
Advances such as hydrogels, nanoparticles, and polymeric micelles have improved drug
targeting, bioavailability, and patient compliance, making polymer-based systems a cornerstone
of modern drug delivery and therapeutic innovation.

2. Definition of Pharmaceutical Polymers

Polymers are large, biocompatible, and chemically modifiable materials widely used in
pharmaceuticals and biomedical fields due to their ability to control, sustain, and target the
release of drugs. They serve as essential components in drug delivery systems, tissue
engineering, prosthetics, and medical devices, improving drug stability, bioavailability, and
patient compliance through controlled and predictable therapeutic release.

Pharmaceutical Polymers.
Are a specialized class of polymers that are pharmaceutically acceptable, non-toxic, and are
incorporated into drug formulations to achieve specific functional objectives beyond mere
dilution. They are integral to the formulation, serving purposes such as:
 Controlling the rate and location of drug release.
  Protecting the drug from the harsh gastric environment.
 Enhancing the solubility of poorly water-soluble drugs.
 Providing mechanical strength and structure to a dosage form.
 Improving the bioavailability of the API.

The selection of a polymer is a critical decision in pre-formulation studies, as its interactions

with the API and its behavior in the biological environment directly influence the drug's
therapeutic outcome.

3. Importance of Polymers in Dosage Forms.

The significance of polymers in dosage forms is multifaceted. They are the cornerstone upon
which modern drug delivery technology is built. Their importance can be summarized as
follows:

Immediate Release Dosage Forms

Tablets;
Polymers are used in immediate-release tablets as excipients to aid manufacturing and protect
drugs from degradation. Starch and cellulose act as disintegrates that swell in water, helping the
tablet break apart and improve drug dissolution. Other polymers like polyvinylpyrrolidone (PVP)
and hydroxypropyl methylcellulose (HPMC) serve as binders and coating agents to enhance
flow, compaction, and appearance.

Capsules;
Capsules are used to deliver poorly compressible or bitter-tasting drugs and to improve
bioavailability. Gelatin is commonly used as the shell material for both hard and soft capsules,
while HPMC is a modern alternative for hard capsules. The same polymeric excipients found in
tablets are often used to fill capsules for immediate drug release.

Modified Release Dosage Forms;

Modified-release dosage forms are designed to overcome the limitations of conventional
immediate-release forms that may cause side effects or inconsistent drug levels. They control the
rate, time, and location of drug release to enhance therapeutic outcomes. These forms improve
patient compliance by reducing dosing frequency and maintaining steady drug concentrations.

Extended Release Dosage Forms;

Extended-release formulations prolong drug action by maintaining therapeutic levels for longer
periods. Common polymers used include Eudragit RS/RL, ethyl cellulose, cellulose acetate, and
polyvinyl acetate. These polymers control water permeability and film strength, ensuring
sustained and predictable drug release.

Gastro retentive Dosage Forms;

Gastro retentive systems stay in the stomach longer, releasing drugs gradually for absorption in
preferred gastrointestinal regions. This approach benefits drugs that are poorly absorbed in the
distal gut. Mucoadhesive and low-density polymers have been tested to increase gastric retention
by adhering to the stomach lining or floating on gastric contents.

4. Selection Criteria for Polymers in Dosage Forms.

The choice of a polymer is a critical and multi-factorial decision in formulation development. An
inappropriate polymer can lead to product failure, instability, or even toxicity. The key selection
criteria are outlined below and summarized in Table 1.

4.1. Physicochemical Properties.

I. Solubility and Swelling Behavior:
The polymer's solubility in aqueous and organic solvents, along with its swelling index in
water, dictates its drug release mechanism. Hydrophilic, swell able polymers are used in
matrix tablets, while insoluble polymers are used for coating.
II. Viscosity and Molecular Weight:
Molecular weight influences mechanical strength, biodegradation rate, and viscosity of
polymer solutions. High molecular weight polymers like HPMC are used as gelling
agents, while lower molecular weight PVP is used as a binder.
III. Glass Transition Temperature (Tg):
The Tg affects the physical state (glassy or rubbery) and the stability of the polymer and
the incorporated drug, especially in solid dispersions.
IV. Permeability:
The polymer's ability to permit the diffusion of water and drugs is crucial for controlled
release systems.
4.2. Biopharmaceutical Considerations.
I. Drug-Polymer Compatibility:
The polymer must not chemically interact with the API in a way that deactivates it or
promotes degradation. Techniques like DSC and FTIR are used to study compatibility.
II. Release Mechanism:
The desired release mechanism (diffusion, erosion, swelling, osmosis) must align with
the polymer's inherent properties.
III. Route of Administration:
The polymer must be suitable for the intended route (e.g., orally accepted polymers
cannot be used for parenteral products without stringent purification).
4.3. Biological Considerations.
I. Biocompatibility:
The polymer and its degradation products must not provoke an adverse immune or
inflammatory response.
II. Biodegradability:
For implantable or injectable depot systems, the polymer should degrade into non-toxic
metabolites that can be easily eliminated from the body.
III. Toxicity and Regulatory Status:
The polymer must be non-toxic, non-carcinogenic, and non-teratogenic. It should ideally
be approved by regulatory bodies like the US FDA and be listed in pharmacopoeias
(USP, Eur.).
4.4. Economic and Practical Considerations.
I. Cost and Availability:
The polymer should be cost-effective and readily available in a consistent quality from
reliable suppliers.
II. Process ability:
It should be amenable to large-scale manufacturing processes like compression,
extrusion, or spray drying.

Table 1: Key Selection Criteria for Pharmaceutical Polymers.

Category Parameter Consideration Example

Physicochemical Solubility Determines drug Insoluble Eudragit RS
release mechanism for sustained release.
(erosion vs. diffusion).
Molecular Weight Affects viscosity, High M.W. Chitosan
strength, and for sustained release;
degradation rate Low M.W. for rapid
dissolution
Glass Transition (Tg) Impacts physical PVPVA with low Tg
stability of solid for amorphous solid
dispersions. dispersions.
Permeability Controls the rate of Silicone rubber in
drug and water transdermal patches
diffusion

Biopharmaceutical Drug Compatibility Must not interact Avoid basic drugs

adversely with the with enteric polymers
API like CAP
Release Mechanism Polymer must HPMC for diffusion-
facilitate the intended controlled matrix
release profile. systems.
Route of Must be safe and PLGA for parenteral;
Administration effective for the HPMC for oral
intended route

Biological Biocompatibility Must be non-irritating PLA, PCL for

and non-toxic. implants and sutures.
Biodegradability Required for PLGA degrades to
implants/injectable; lactic and glycolic
must have safe by- acid
products
 Regulatory Status Should be GRAS or Most cellulose
approved by derivatives are widely
FDA/EMA. approved

Economic/Practical Cost Must be commercially Starch is very cheap;

viable for the product some specialized
polymers are
expensive
Process ability Should be suitable for Flow properties of
standard microcrystalline
manufacturing cellulose for direct
equipment compression

5. Classification of Pharmaceutical Polymers.

Pharmaceutical polymers can be classified based on several characteristics, including their

origin, interaction with water, polymerization method, and molecular structure.

Pharmaceutical Polymers

Basis on interaction with water;

‐ biodegradable hydrophobic Polymers: ‐ E.g. Polyvinyl chloride,
‐ ‐ E.g. Polyvinyl pyrimidine

Based on polymerization method;

‐ ‐ E.g. Polystyrene
and Polyamide

Based on chemical structure;

‐

Based on polymerization mechanism;

Based on occurrence;
‐ E.g. keratin, albumin, cellulose1. Proteins‐
polymers: ‐ E.g. Polyesters, polyamides

Based on bio‐ stability;

‐ ‐ degradable
5.1. Classification Based on Source
5.1.1. Natural Polymers
These are obtained from natural resources such as plants, animals, and microorganisms. They are
generally biocompatible, biodegradable, and inexpensive. However, they can suffer from batch-
to-batch variability and potential immunogenicity.
Examples:
I. Polysaccharides:
 Starch: Used as a disintegrate and binder in tablets.
 Cellulose: The raw material for many semi-synthetic polymers.
 Alginates: Used in gel-forming systems and as disintegrates. Sodium Alginate forms gels
in the presence of calcium ions.
 Chitosan: Derived from chitin, it is mucoadhesive and permeation-enhancing. Used in
nasal and oral delivery.
 Guar Gum: Used as a binder, disintegrate, and for controlled release.
II. Proteins:
 Gelatin: Used in capsule shells and as a binder.
 Albumin: Used in nanoparticle drug delivery.

5.1.2. Semi-Synthetic Polymers

These are derived from naturally occurring polymers by chemical modification. This class
combines the advantages of natural polymers (biocompatibility) with improved and more
consistent properties of synthetic ones.
I. Cellulose Derivatives:
 Methyl Cellulose (MC), Hydroxypropyl Methylcellulose (HPMC): Used as matrix
formers in controlled-release tablets, film formers, and viscosity enhancers in ophthalmic
solutions.
 Carboxymethyl Cellulose (CMC): Used as a suspending agent and tablet disintegrate.
 Ethyl Cellulose (EC): A water-insoluble polymer used for coating to provide sustained
release or taste masking.
 Cellulose Acetate Phthalate (CAP): A classic enteric coating polymer that dissolves at
intestinal ph.
II. Starch Derivatives:
 Sodium Starch Glycol ate: A super-disintegrate.

5.1.3. Synthetic Polymers

These are entirely man-made through chemical synthesis. They offer the highest degree of
uniformity, purity, and control over properties (e.g., molecular weight, copolymer ratio). They
can be further divided into biodegradable and non-biodegradable.
I. Biodegradable Synthetic Polymers:
 Poly (lactic acid) (PLA), Poly (glycolic acid) (PGA), and their copolymer Poly
(lactic-co-glycolic acid) (PLGA): The gold standard for biodegradable polymers. Used
in micro particles, implants, and sutures. They degrade by hydrolysis into metabolizable
acids.
 Poly(ε-caprolactone) (PCL): A slower-degrading polymer used in long-term
implantable devices.
  Poly (alkyl cyanoacrylates): Used in tissue adhesives and nanoparticle drug delivery.
II. Non-Biodegradable Synthetic Polymers:
 Poly(meth)acrylates (Eudragit®): A family of polymers with diverse functionalities
(e.g., Eudragit L/S for enteric coating, Eudragit RL/RS for sustained release).
 Polyvinylpyrrolidone (PVP): Used as a binder in tablets and as a carrier in solid
dispersions to enhance solubility.
 Polyethylene Glycol (PEG): Widely used as a plasticizer, lubricant, and for PEGylating
proteins to improve their circulation time.
 Polyvinyl Alcohol (PVA): Used as a film former in ophthalmic drops and as a viscosity-
enhancing agent.

6. Applications of Pharmaceutical Polymers

The applications of polymers in drug delivery are vast and continuously expanding. They are the
enabling technology for most advanced drug delivery systems.

Water‐ Soluble Synthetic Polymers;

‐ weight
Poly (ethylene glycol) Mw <10,000; liquid (Mw<1000)

make betadine(iodine complex of PVP) with less toxicity than iodine, plasma replacement, tablet
y (vinyl alcohol) Water‐ soluble packaging, tablet binder, tablet coating.

Cellulose‐ Based Polymers;

water, aqueous coating system for sustained release
applications disintegrate, emulsion stabilizer
and hydroxypropyl celluloses Soluble in water
Hydroxypropyl methyl cellulose Binder for tablet matrix and tablet coating, gelatin alternative as
capsule se acetate phthalate enteric coating

. Hydrocolloids;

variety of pastes, creams, and gels, as well as stabilizing agent for oil‐ in‐ water emulsions;
binder and di
controlled drug delivery applications, mucoadhesive dosage forms, rapid release dosage forms.

Water‐ Insoluble Biodegradable Polymers;

‐ co‐ glycoside) polymers nanoparticle for protein delivery

8. Conclusion

Polymer-based pharmaceuticals are becoming crucial in treating serious diseases like cancer and
hepatitis. While excipients were once considered inactive ingredients used only to aid
manufacturing, they are now designed to enhance drug delivery and overcome poor drug
properties. Synthetic polymers can be customized by modifying their characteristics, whereas
natural polymers are biocompatible, non-toxic, eco-friendly, and cost-effective. Many polymers
are already used successfully as excipients, and new ones continue to be explored for improved
pharmaceutical formulations.
Appendix: Examples of Commonly Used Polymers and Their Functions

Polymer Type (Source) Key Function(s) in Dosage

Form
Hydroxypropyl Semi-synthetic Matrix former for controlled
Methylcellulose (HPMC) release, film coating, binder,
viscosity enhancer
Ethyl Cellulose (EC) Semi-synthetic Water-insoluble coating for
sustained release, taste masking
Eudragit L100/S100 Synthetic Enteric coating (dissolves at
intestinal pH).
Polyvinylpyrrolidone (PVP) Synthetic Binder in tablets, carrier in
solid dispersions for solubility
enhancement
Polylactic-co-glycolic acid Synthetic (Biodegradable) Biodegradable polymer for
(PLGA) microparticles, nanoparticles,
and implants.
Sodium Starch Glycolate Semi-synthetic Super-disintegrant in tablets
and capsules.
Carbopol Synthetic (Cross-linked PAA) Gelling agent, mucoadhesive
polymer in topical and
bioadhesive formulations.
Chitosan Natural Mucoadhesive polymer,
permeation enhancer, used in
nasal and oral delivery
Polyethylene Glycol (PEG) Synthetic Plasticizer, lubricant, base for
suppositories, PEGylation of
proteins.

9. References
This reference list includes a mix of foundational textbooks and review articles to demonstrate
the use of both books and journal articles.
1. Lieberman, H. A., Lachman, L., & Schwartz, J. B. (Eds.).(1990). Pharmaceutical Dosage
Forms: Tablets (Vol. 1-3). Marcel Dekker.
(A classic, comprehensive text on tablet formulation, extensively covering the use of
polymers as binders, disintegrants, and matrix formers.)
2. Krushnakumar J Gandhi*, Subhash V Deshmane, Kailash R BiyaniDepartment of
Pharmaceutics, Anuradha College of Pharmacy, Chikhli, Dist‐ Buldana 443201, India.
3. Peppas, N. A., & Khare, A. R. (1993).Preparation, structure and diffusional behavior of
hydrogels in controlled release. Advanced Drug Delivery Reviews, 11(1-2), 1-35.
 (A seminal review article on the science of hydrogels and their application in controlled
release.)
4. Verma, R. K., & Garg, S. (2001). Current status of drug delivery technologies and future
directions. Pharmaceutical Technology, 25(2), 1-14.
(Provides an overview of various drug delivery technologies, highlighting the role of
polymers.)
5. United States Pharmacopeia and National Formulary (USP-NF).Current Edition.
(The official compendia providing monographs and standards for numerous
pharmaceutical polymers, ensuring their quality and safety.)