Liquid oral preparation refers to a clarified liquid preparation for oral administration made by dissolving API in a suitable solvent (generally water) and adding solubilizers, bacteriostatic agents, antioxidants, flavor enhancers and other excipients as required. Liquid oral preparations usually have the advantages of rapid absorption, high efficiency, good patient compliance, flexible dosage and so on, especially for the elderly, children and other patients who have difficulty swallowing.
Liquid oral generic drugs are oral dosage forms that may be exempted from bioequivalence studies, and the research focus of the sponsors in the consistency evaluation is somewhat different from that of oral solid preparations, injections and other dosage forms.
Our Services
Compared with oral solid preparations, liquid oral preparations are prone to degradation, high risk of microbial contamination, and inconvenient to store and carry. Leveraging the experience of our expert team and industry-leading research platform, we provide generic liquid oral dosage form development and registration services to global pharmaceutical companies.
Formulation and Manufacturing Process Studies
If a sponsor intends to apply for a bioequivalence exemption for its liquid oral generic drug, we recommend consistency with the RLD for excipients that may affect drug absorption or bioavailability. In addition, process parameters such as the order of addition of raw and auxiliary ingredients, mixing speed, dissolution temperature and time, and filling process and time will be studied.
Quality Studies
We have conducted in-depth studies of the requirements of various regulatory agencies for the consistency evaluation of liquid oral formulations, fully examining the characteristics of the generic drug and focusing on the differences from the RLD, including but not limited to:
- Characterization
- Identification
- pH value
- Relative density
- Viscosity
- Related substances
- Content
- Clarity and color of solution
- Antioxidant content
- Microbial limits
Due to the special nature of liquid oral preparations, in addition to routine microbiological limit checks, we also study the possible effects of other specific microorganisms on drug safety.
- Dosage administered
- Compatibility
Stability Studies
We carry out stability studies of generic oral solutions in accordance with the regulations and relevant principles in the client's region, focusing on changes in appearance, pH, solution clarity, related substances, content, antioxidant content, microorganisms and other indicators, and ensuring that the stability of generic drugs should be no less than the RLD.
Bioequivalence Exemption
Because liquid oral formulations generally have no dissolution process in vivo, they may be exempted from human bioequivalence studies under certain conditions. FDA exempts oral solutions, elixirs, syrups, tinctures, or other solution-based formulations from human bioequivalence testing if in vivo bioequivalence is apparent. EMA indicates that the generic drug is administered as an aqueous oral solution and has the same concentration of active ingredient as approved oral solutions.
Requirements for bioequivalence exemption for generic liquid oral formulations vary from region to region. Our company carefully evaluates the client's project to determine whether a bioequivalence exemption can be applied.
Preparation and Submission of Application Documents
Our company prepares drug registration documents for our clients, including pharmacological study data, clinical study data and manufacturing information. In addition, we provide services to review and revise application documents to ensure that our clients' documents comply with the requirements of the regulatory authorities in the target markets.
Our consistency evaluation of liquid oral generic drug services includes not only technical support, but also project management, regulatory consulting and marketing strategy. We provide our clients with comprehensive one-stop services and are committed to becoming their most trusted partner in the generic drug field.
