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Manufacturing Challenges of Liquid Dosage Form

A list of challenges during manufacturing of liquid dosage forms are given below : 

Stability issues: liquid dosage forms are susceptible to chemical and physical changes over time, leading to degradation, alteration of drug potency, and even contamination.

Poor solubility: some drugs are difficult to solubilize in liquid media, leading to precipitation and subsequent sedimentation or clogging of equipment.

Product uniformity: variations in the concentration of active ingredients or excipients, as well as improper mixing or homogenization, can result in products that are inconsistent in potency or appearance.

Container closure Integrity: inadequate closure systems may allow the entry of oxygen or moisture, leading to product degradation, contamination, or decreased shelf-life.

Foaming: agitation and shear forces can lead to the formation of foam, which can affect product stability, degrade the container closure system, and compromise product dosing accuracy.

Particle aggregation: solid particles present in liquid formulations can aggregate over time, leading to sedimentation, inconsistent dosing, and potential blockages in drug delivery devices.

Compatibility issues: interactions between active ingredients or excipients, as well as interactions with container materials, can lead to changes in product appearance, stability, or efficacy.

Microbial contamination: liquid dosage forms are particularly susceptible to microbial contamination, which can proliferate rapidly and lead to product recall and safety concerns.

Improper Dosing: errors in product dosing, packaging, or labeling can have serious consequences, including adverse events and product recalls.

Manufacturing process failures: deficiencies in the manufacturing process, such as inadequate quality control measures, deviations from standard operating procedures, or equipment failures, can result in products that are defective or unsafe for human use.

Read also: Pharmaceutical Suspension | Physical and Chemical Stability

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