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Lecture On SEMISOLIDS

Semisolids are topical dosage forms containing active ingredients in a suitable base, used for therapeutic or cosmetic purposes, and can be applied to the skin or other areas. They possess properties such as clinginess and plastic behavior, with ideal characteristics including smooth texture and non-irritation. Common formulations include ointments, pastes, creams, and gels, which are prepared using various equipment and stored under controlled conditions to maintain quality before packaging.

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10 views13 pages

Lecture On SEMISOLIDS

Semisolids are topical dosage forms containing active ingredients in a suitable base, used for therapeutic or cosmetic purposes, and can be applied to the skin or other areas. They possess properties such as clinginess and plastic behavior, with ideal characteristics including smooth texture and non-irritation. Common formulations include ointments, pastes, creams, and gels, which are prepared using various equipment and stored under controlled conditions to maintain quality before packaging.

Uploaded by

kanwal
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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SEMISOLIDS

DEFINITION
 “Semi solids are topical dosage form containing one or more
active ingredients dissolved or uniformly dispersed in a suitable
base and suitable excipients (emulsifier etc.) that are used for
therapeutic, protective or cosmetic function.”
 They may be applied on skin or used nasally, vaginally or rectally.

PROPERTIES
 Their common property is the ability to cling for suitable time to the
surface on which it is applied.
 Above property is due to their plastic rheologic behavior.

IDEAL SEMI SOLIDS


 Smooth texture  Non-irritating
 Elegant in appearance  Do not alter membrane
 Non dehydrating function
 Non gritty  Miscible with skin secretion
 Non greasy and non-non-  Easy applicable with efficient
staining drug release
 Non hygroscopic Physiological  High aqueous washibility
properties (stable, don’t
change consistency or
degrade due to moisture
absorption)

 Creams
 Gels
SEMI SOLIDS FORMULATIONS
 Ointments
 Pastes
I. OINTMENTS
 They are generally composed of
 fluid hydrocarbons generally meshed in a higher melting solid
hydrocarbons.
 Most ointments are based on mineral oils and petroleum which facilitates the
delivery of active ingredients and enhances skin penetration.
 Melting of all components together. Drugs and other components are
added in fluidized state.
  If the solids to be mixed are insoluble, the system is put
through a milling process (colloid mill, homogenizer or ultrasonic
mixer)
II. PASTES
 Pastes are basically ointments but with very high percentage of insoluble
solids
PREPARATION MECHANISM
 They are prepared by incorporating a solid directly into congealed
system by levigating with a portion of base to form paste like mass.
Remainder of base is added until solids are uniformly mixed.
III. CREAMS
 They are semisolid emulsion systems with opaque appearance.
 Their properties depend upon emulsion types (oil in water or water in
oil)
IV. GELS
 Gels are semisolid systems in which a liquid phase is constrained
within a three-dimensional polymer matrix (containing natural or
synthetic gums) in which high degree of physical (sometimes chemical)
cross- linking is present.
 Natural gums used ( tragacanth, pectin etc.)
 Synthetic materials ( methyl-cellulose etc.)
PREPARATION MECHANISM
 They are usually prepared by fusion process.
EQUIPMENT FOR SEMISOLID PREPARATION
 A wide range of machines are available for large-scale production of
ointments and creams. Each of these machines is designed to perform
certain unit operation, such as milling, separation, mixing, emulsification
and deaeration. (Deaeration is the process of removing dissolved gases
(such as air or oxygen) from a liquid formulation, and it is an important
step in the preparation of semi-solids like ointments and creams).
I. MILLS
 Milling is performed to reduce the size of actives and other additives
various mills used for this purpose are:
• Fluid mills • Compression mills
• Impact mills • Tumbling mills
• Cutter mills • Roller mill
• Colloid mill
 Mechanism of size reduction
• Cutting • Impact
• Compression • Attrition
II. SEPARATORS (sieving)
 Separators are employed for separating materials of different size,
shape, and densities. Two types of separators are mostly used for
separation. These are:
• Centrifugal separators (cyclone separator)
• Vibratory shakers
Vibratory shaker

Centrifugal separator

III. MIXERS
 Mixing of the active and other formulation components with the
ointment or cream base is performed using various types of mixers,
such as:
• Agitator mixers
• Roller mills
 Mixers with heating provisions are also used to aid in the melting of
bases and mixing of components.
MECHANISM OF MIXING
Convective mixing  Positive mixtures
 Shear mixing  Negative mixtures
TYPES OF MIXTURES IV. EMULSIFIERS
 Diffusive mixing

 Neutral mixtures
 These emulsifiers are used to disperse the hydrophilic components in
the hydrophobic dispersion phase (e.g. water-in-oil creams) or
oleaginous materials in aqueous dispersion medium (oil-in-water
creams).
 The choice includes:
• Low shear emulsifiers
• High shear emulsifiers • Ultrasonic emulsifier
V. DEAERATION
 Entrapment of air into the final product due to mixing processes is a
common issue in large scale manufacturing of semisolid dosage
form.
Various offline and in line deaeration procedures are
adopted to minimize this issue. Effective deaeration is
generally achieved by using vacuum vessel
deaerators.
VI. SHIFTERS, HOLDERS, FILLERS, AND SEALERS
 Various low and high shear shifters are used to transfer
materials from the production vessel to the packaging
machines. In the packaging area, various types of
holders, fillers, and sealers are used to complete the
unit operation.

STORAGE OF SEMI SOLIDS


 After semi solid dosage forms are prepared, they have
to go through quality control testing. This process can
take time, but during this time, semi solids are needed
to be stored properly, otherwise they will deteriorate
by evaporation of water and other volatile
components.

So, Before final packaging, semisolids are typically stored temporarily under
controlled conditions to maintain their quality and stability. Here’s how they are
usually stored:

1. Stainless Steel Containers or Vessels: Semisolids are often transferred to


stainless steel containers or holding vessels that are designed to prevent
contamination. These containers are usually equipped with airtight lids to
avoid exposure to air and moisture.
2. Temperature Control: The storage area is kept at a controlled temperature
suitable for the semisolid formulation. For instance, room temperature or
refrigerated conditions may be used, depending on the temperature
sensitivity of the formulation.
3. Agitation or Mixing: Some semisolids may need to be kept in containers
with slow, gentle mixing to maintain homogeneity and prevent settling of
any dispersed ingredients.
4. Protective Atmosphere: In certain cases, semisolids may be stored under a
protective inert gas atmosphere (like nitrogen) to minimize oxidation and
maintain stability.
5. Covered and Sealed Storage: The semisolid is stored in a manner that
minimizes exposure to air, light, or humidity. Containers are often sealed
tightly or kept in light-proof coverings to protect against degradation.
6. Cleanroom Conditions: If the semisolids are sensitive to contamination,
they are stored in a cleanroom or controlled environment with
appropriate air filtration and hygiene standards.

These precautions help ensure that the quality, consistency, and safety of the semisolids are
maintained until they are ready for final packaging and distribution.

PACKAGING OF SEMI SOLIDS


FILLING
 When the QC and QA processes are completed, semi
solid preparations are filled in suitable containers.
Most of the filling is due to transfer of materials into
container by gravitational forces but filling can also be
done with help of pumps or tubes.
 There should be proper and regular cleaning of
filling equipment to ensure no contamination and
other bad impacts like bubbles during filling.
CONTAINERS
Containers used for packaging semisolid dosage forms are specifically
designed to protect the product while allowing convenient use and
dispensing. Here are some common types of containers used for
packaging semisolid dosage forms like ointments, creams, gels, and
pastes:
1. Collapsible Tubes:
o Material: Made from metal (aluminum, tin) or plastic (laminated
materials).
o Usage: Widely used for creams, ointments, and gels.
o Advantages: Provides good protection from contamination, prevents
air and moisture entry, allows easy dispensing, and minimizes
product waste.
o Drawbacks: Metal tubes may react with some formulations, so
proper internal coatings may be needed.
2. Jars:
o Material: Made from glass, plastic (polypropylene, polyethylene), or
metal.
o Usage: Used for creams, ointments, and pastes.
o Advantages: Easy to fill and access the product.
o Drawbacks: Exposure to air and contaminants can occur upon
opening, reducing the stability of some formulations.
3. Sachets:
o Material: Composed of plastic films or laminated materials.
o Usage: Used for single-use applications, such as sample sizes of
creams or gels.
o Advantages: Convenient for single-dose packaging, lightweight, and
easy to carry.
o Drawbacks: May not be suitable for large-volume products and may
not provide long-term stability for sensitive formulations.
4. Pump Dispensers and Airless Pump Bottles:
o Material: Typically made from plastic or glass.
o Usage: Suitable for high-viscosity gels and creams.
o Advantages: Protects the formulation from air exposure, provides
controlled dosing, and enhances product stability.
o Drawbacks: More expensive compared to other packaging types and
requires specific filling techniques.
5. Plastic Tubs:
o Material: Usually made from polypropylene or polyethylene.
o Usage: Used for bulk storage of ointments, creams, and pastes.
o Advantages: Economical for large quantities and easy to fill.
o Drawbacks: Not suitable for light-sensitive formulations unless an
opaque material is used.
6. Syringes and Applicators:
o Material: Made from plastic.
o Usage: Used for specific applications, such as rectal or vaginal gels.
o Advantages: Allows for precise application directly at the site of
action.
o Drawbacks: Limited to specific formulations and may not be suitable
for all semisolid dosage forms.
These containers are selected based on the specific requirements of the
semisolid formulation, including stability, dosing, protection from
contamination, and ease of use.

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