Miconazole base oral gel 2% FTM

Oral gel: Miconazole base oral gel 2% FTM. Additional appearance criteria are not established by the specific text reviewed. ^[1]

Oropharyngeal mucosal candidiasis. ^[1]

Hypromellose: 2% solution viscosity at 20 °C 3000–5600 mPa·s. ^[1]

Finished-product photostability is not specified. Any required container light protection is stated under Storage. ^[1]

No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. ^[1]

Glycerol is miscible with water. This does not establish product microbiological stability.
Miconazole: JP classifies the corresponding pure raw material as practically insoluble in water.
Component of base CGR-BE-003: Methyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-BE-003: Propyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as very slightly soluble in water. ^{[2], [4], [8], [9], [10]}

Glycerol is hygroscopic; limit raw-material exposure to moisture. ^[2]

For the finished product the source specifies:
Tube, 15–25 °C. ^[1]

No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. ^[1]

Glycerol: hazardous reaction with strong oxidising agents. ^[2]

Glycerol: clear, colourless, viscous and strongly hygroscopic liquid. It mixes with water but is practically insoluble in fixed and essential oils.
Miconazole: raw-material water solubility is classified as practically insoluble by JP.
Glycerol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit.
Component of base CGR-BE-003: Methyl Parahydroxybenzoate: raw-material water solubility is classified as slightly soluble by JP.
Component of base CGR-BE-003: Propyl Parahydroxybenzoate: raw-material water solubility is classified as very slightly soluble by JP. ^{[2], [4], [5], [8], [9], [10]}

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [3], [6]}

Reference batch: 100 g. First ingredient: Miconazole base, 2 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: confirm final volume or mass at the reference temperature, intended clarity or dispersion, and specified container/closure. Do not equate grams and millilitres without a justified density. ^{[1], [12], [14]}

Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. ^{[1], [6]}

Period reported by source: 2 months.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately. ^{[1], [7], [11], [13], [15]}

Preserved water FTM: CGR-BE-003 ^[1]

Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. ^[1]

Dry-mix miconazole and hypromellose. Gradually add glycerol, oil and water to 100 g. Cover and refrigerate for about 12 h to hydrate. Homogenise and package. ^[1]

Miconazole base, not nitrate, is required. Use a calibrated dropper and assess interactions and patient suitability for an oral gel. ^[1]

Tube as specified by the procedure. ^[1]

Hypromellose: 2% solution viscosity at 20 °C 3000–5600 mPa·s.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. ^{[1], [5], [14]}

Tube, 15–25 °C. ^[1]

Oral gel may obstruct the airway/cause choking in young children. Check current age eligibility and major miconazole interactions before dispensing. ^[1]

Miconazole base oral gel 2% FTM
Oral topical use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tube, 15–25 °C.
Temperature for this batch BUD: ____ ^[1]

The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.