Chewable tablets, as a special oral solid dosage form, offer advantages such as ease of administration, pleasant taste, and the ability to be chewed without swallowing. They are widely used in the treatment of children, the elderly, and patients with dysphagia. The production process must balance drug stability, taste control, and disintegration performance, and primarily includes the following key steps.
Raw material pretreatment and formulation design are fundamental to production. Based on the drug's properties, appropriate fillers (such as microcrystalline cellulose), binders (such as hypromellose), flavoring agents (such as aspartame), and disintegrants (such as crospovidone) are selected. Experimental optimization of the formulation ensures tablets with appropriate hardness, pleasant taste, and rapid disintegration.
Granulation and drying are key processes. In wet granulation, raw materials and excipients are mixed and then a binder solution is added to create a soft material. Granulation is then extruded through a screen to form wet granules, which are then dried in a fluidized bed or oven to the required moisture content (typically ≤3%). Dry granulation is suitable for heat-sensitive materials and is performed by roller compaction before granulation. During the tableting process, tablet press parameters must be strictly controlled to ensure the tablets possess sufficient mechanical strength to withstand transportation while maintaining palatability during chewing. Mold selection and punch surface treatment directly impact the appearance quality.
During the coating and packaging stage, film coating techniques (such as hypromellose coating) can be used to mask unpleasant drug tastes or enhance stability. After passing quality inspection, the final product is sealed in aluminum-plastic blisters or bottles to ensure moisture and light protection.
The chewable tablet production process requires rigorous process control and validation to balance drug efficacy, physical properties, and patient compliance, ultimately ensuring safe and effective product delivery.
