semisolid Flashcards
Are dosage forms intended for insertion into body orifices (rectum, vagina, urethra) where they melt,soften,or dissolve and exert a local or systemic
vagina, urethra) where they melt, soften, or dissolve and exert a local or systemic effect where the base plays an important role in this respect.
Suppositories
These are globular, oviform, or cone-shaped and typically weigh 5g with a cocoa butter base, though weight varies by base and manufacturer.
Vaginal Suppositories (Pessaries)
Used for vaginal yeast infections.
Clotrimazole
Treats bacterial vaginosis.
Metronidazole
Often used in hormone replacement therapy or fertility treatments.
Progesterone Suppositories
Are 32 mm long, cylindrical, with tapered or bullet-shaped ends. Adult
suppositories weigh 2g (cocoa butter base), while pediatric ones are smaller
(1g) and pencil-shaped. They are used for local or systemic effects.
Rectal Suppositories
For constipation relief.
Bisacodyl
Used to reduce fever or relieve pain.
Acetaminophen
For treating hemorrhoids or rectal inflammation.
Hydrocortisone
These are slender and pencil-shaped. Male versions are 140 mm long, 3–6 mm in diameter, and weigh 4 g. Female versions are 70 mm long and 2 g, both
typically using cocoa butter as the base
Urethral Suppositories (Bougies)
For erectile dysfunction; inserted directly into the urethra
Alprostadil
Problems in Formulation
• Water in Suppositories
• Hygroscopicity
• Drug-excipient Interactions
• Viscosity
• Brittleness
• Density
• Lubrication of Molds
• Volume Contraction
• Displacement Value
• Weight and Volume Control
• Rancidity
It may be defined as the number of parts by weight of medicament that displaces one part by weight of the base.
Displacement Value
It occurs when the active ingredients and excipients are not evenly dispersed within the base.
This can result from inadequate mixing time, improper use of mixing equipment, incorrect temperature control, or operator error.
Non uniformity of the mix
When the mixing time is too short, ingredients do not achieve uniform distribution, while overmixing can lead to overheating and degradation of sensitive components.
It occurs when active or excipient substances separate out from the
mixture, typically due to inadequate mixing, incorrect temperature control, or operator errors.
This often happens when the temperature drops below the solubility limit of certain components, or when mixing equipment fails to maintain proper agitation.
Precipitation of Components
It is a critical issue during mixing that can compromise the stability and efficacy of the product. This typically results from excessive temperatures during mixing, prolonged batching times, or the use of unsuitable equipment.
Decomposition of Components
This issue arises when the suppository splits or tears during removal from the mold. The primary causes include improper mold design, surface irregularities, or rapid cooling of the
suppository base, which leads to uneven shrinkage and stress.
Tearing and Splitting
It occurs when suppositories fail to close properly, often due to insufficient
filling of molds, overheating during sealing, or poor alignment of mold parts.
Improper Sealing
It manifest as imperfections like air bubbles or uneven textures on the
suppository’s exterior. They are commonly caused by trapped air during mixing or pouring, contamination in the base or molds, or incorrect pouring temperatures.
Surface Defects
These are common structural issues.
Soft suppositories, cracking, and granulation.
It typically occur due to inadequate solidification, which results from insufficient cooling time or
an improper base composition with a low melting point
Soft Suppositories