Part 6 Pengemasan dan stabilitas supositoria

Packaging and Stability of Suppositories
📌 Pharmaceutical packaging must maintain the quality and stability of the dosage form, including protection against contamination from solids, liquids, and gases.
📌 Packaging types for suppositories include aluminum foil (often for compounding), blister packs, or strip packaging made of plastic or aluminum.
📌 Suppository packaging often doubles as the mold during manufacturing, requiring it to maintain its shape.

Types of Stability
📌 There are five types of stability to consider: chemical, physical, microbiological, therapeutic, and toxicological.
📌 Chemical stability focuses on maintaining the drug concentration within the labeled amount, typically between 90%–110% of the stated dose, unless specified otherwise.
📌 Physical stability relates to appearance, uniformity, and odor, while microbiological stability concerns contamination by microbes like fungi and bacteria.

Factors Affecting Suppository Stability and Common Changes
📌 Common issues include changes in aroma (often due to fungal contamination, especially if water-based extracts are used), color/shape changes due to improper storage temperatures, and weight changes.
📌 External factors influencing stability are temperature, light, Relative Humidity (RH), and oxygen, while internal factors include active ingredient particle size, pH, formulation composition, and packaging quality.
📌 Temperature control is crucial because if the storage temperature is below or equal to the melting point, the suppository can lose its physical stability.

Storage Requirements Based on Base Type
📌 Suppositories with a cocoa butter base should generally be stored in a cold temperature range, ideally between 2°C and 8°C.
📌 Suppositories with a glycerin/gelatin base require controlled room temperature (aiming for 20°C–25°C) and must be protected because they are highly hygroscopic.
📌 PEG bases do not require strict temperature control as they dissolve rather than melt, but humidity must be controlled because they are also hygroscopic.

Key Points & Insights
➡️ Packaging must ensure the integrity of the drug content against external contaminants and environmental factors.
➡️ Suppositories stored at high RH risk moisture absorption, leading to microbial contamination or hydrolysis if the material is susceptible.
➡️ Low RH can cause suppositories to lose moisture, making them more brittle, similar to capsules.
➡️ Storage conditions must be tailored specifically to the suppository base (e.g., Cocoa Butter $\rightarrow$ refrigerated; PEG $\rightarrow$ controlled RH).

📸 Video summarized with SummaryTube.com on Dec 14, 2025, 23:29 UTC