EXCIPIENTS REVIEW - LACTOSE AND STARCH

1. AS
A PHARMACEUTICAL EXCIPIENT
LACTOS
E

2. 1
OUTLINE  Introduction
 Characteristics
 Uses and Applications
 Undesirable Properties of Lactose
 Conclusion

3. 2
Introduction
Drugs are composed of active pharmaceutical ingredients (APIs),
commonly considered the most important substances in the
formulation because of their pharmaceutical action, and excipients,
usually critical for drug bioavailability.
Lactose is one of the most commonly used excipients in the
pharmaceutical industry, owing to its physical and chemical
properties such as chemical inertia, stability, and non-toxicity,
besides being moderately priced.

4. Soluble in water, forming a clear, colorless
solution. The solubility increases with
temperature.
Has a mildly sweet taste but is
less sweet compared to sucrose
(table sugar).
3
Characteristics
Has excellent flowability and
compressibility as well as its rheological
properties .

5. 4
Uses & Applications
Binder: helps hold ingredients together and improves the
mechanical strength of the tablet. It is often included in the wet
granulation process as a binding agent.
Diluent: can be used as a diluent in tablets and capsules to
increase the bulk achieve the desired tablet weight and size,
ensuring uniformity
Disintegrant: promoting the rapid breakup of the tablet into smaller
particles upon contact with moisture. It facilitates the release of the
drug for absorption.

6. 5
Uses & Applications
Direct Compression Vehicle: allow the direct compression of the
API and other excipients without the need for granulation in tablets.
Carrier for Dry Powder Inhalation: the fine particles of the drug
are mixed with lactose to facilitate dispersion and delivery to the
respiratory system.
Taste Masking: mask the taste of bitter drugs, making the
pharmaceutical formulation more palatable for patients.
Vehicle for Dry Granulation: helps to form granules that can then
be compressed into tablets.

7. 6
Uses & Applications
Stabilizer in Freeze-Drying: in lyophilization process for the
production of pharmaceuticals, helping to preserve the stability of
the drug.
Solubility Enhancement: may enhance the solubility of certain
drugs in formulations, contributing to their bioavailability.

8. Plasticization can result in a
lactose glass transition,
creating viscosity problems
and stickiness .
Potential for microbial
contamination
Low solubility can result in
crystallization, giving a gritty
and sandy mouthfeel in the
final product.
Maillard browning reactions,
when exposed to heat &
moisture, result in change in
colour, flavour and odour.
7
Undesirable Properties of Lactose
Lactose intolerance in some
cases leads to digestive
discomfort.
Hygroscopic, can absorb
moisture from the
environment

9. 8
Conclusion
Lactose remains a widely used and versatile excipient in the
pharmaceutical industry.
Modified forms of lactose, such as lactose monohydrate and
spray-dried lactose, are available to address some of challenges
and enhance the suitability of lactose in various formulations.

10. AS
A PHARMACEUTICAL EXCIPIENT
Starch

11. 1
OUTLINE  Introduction
 Characteristics
 Uses and Applications
 Undesirable Properties of Starch
 Conclusion

12. 2
Introduction
Starch is one of the most traditional excipients used for solid dosage
formulations.
Chemically, starches are polysaccharides, composed of a number of
monosaccharides or sugar (glucose) molecules linked together with
α-d-(1-4) and/or α-d-(1-6) linkages.

13. Insoluble in cold water, forming
granules that do not dissolve
easily
Hydrolysis, enzymes such as
amylase catalyze the hydrolysis
of starch into maltose and other
carbohydrates.
3
Characteristics
When heated in the presence of water, the
hydrogen bonds between starch
molecules break, and the granules swell,
absorbing water gel-like substance
(gelatinization).

14. 4
Uses & Applications
Binder: helps hold the tablet ingredients together and improves the
mechanical strength of the tablet. Also starch paste or modified
starches may be used as binding agents in wet granulation
processes.
Disintegrant: promotes the rapid breakup of the tablet into smaller
particles upon contact with moisture and facilitates the release of the
drug for absorption. Also modified starches are often used to
enhance disintegration properties.
Diluent: Starch can be used as a diluent in tablets and capsules to
increase the bulk achieve the desired tablet weight and size,

15. 5
Uses & Applications
Thickening Agent: can be employed as a thickening agent in liquid
formulations, such as syrups and suspensions. It contributes to the
viscosity of the formulation, aiding in the stability of suspended
particles.
Lubricant: reduces the friction between the tablet components and
facilitate the manufacturing process and prevent sticking to the
tablet press punches and dies.
Sustained Release Matrix: Modified starches can be used as
components of sustained-release formulations, where they
contribute to a controlled and prolonged release of the drug over

16. 6
Uses & Applications
Vehicle for Powder Inhalation: Starch-based carriers may be used
in the formulation of dry powder inhalers, aiding in the dispersion
and delivery of the drug to the respiratory system.
Coating Agent: provides a protective and visually appealing outer
layer.

17. Limited compatibility with
acidic pH
Gelatinization at high
temperatures
Hygroscopic, can absorb
moisture from the
environment
Limited solubility in cold
water
Potential for microbial
contamination
7
Undesirable Properties of Starch
Allergenic concerns in rare
cases to specific sources of
starch

18. 8
Conclusion
Starch and modified starches are safe and well-established
excipients.
Starch can be physically modified to enhance its properties and to
improve its performances.
Starch can be also chemically modified to obtain a very wide
range of new properties that can play an important role in the
formulation of complex delivery systems.

19. BY
Hossa
m
Khayyal
Mohannad
Hatata
THANK YOU