Multi-Component Multivitamin Syrup for Young Children: Selecting Composition, Optimising Technology, Increasing Shelf Life

INTRODUCTION. Modern pharmaceutical market mainly offers the range of multivita min liquid medicinal products for children aged 1 to 3 years as dietary supplements. They contain excipients (preservatives, sucrose, synthetic flavours and dyes) unsafe for use in young children. Extemporaneous medicinal products allow minimising the amount of excipients undesirable for children. Some promising ways to improve small-scale extemporaneous preparation include unified prescriptions, modified process, and reasonably extended shelf life.

AIM. This study aimed to optimise formulation and production process of an extemporaneous multivitamin for paediatric patients.

MATERIALS AND METHODS. The research object was sorbitol-based multivitamin syrup prepared extemporaneously that contains ascorbic acid, nicotinic acid, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride (vitamins С, РР, В₁, В₂, В₆) in the concentrations meeting physiological needs of young children aged 1 to 3 years. The authors used active pharmaceutical ingredients that meet regulatory requirements for the above vitamins and sorbitol. Components were identified by specific quality tests; assay of the components included chemical and physico-chemical methods (spectrophotometry, spectrofluorimetry, and refractometry), adapted considering their total content. Both process parameters of the syrup (density, pH values) and organoleptic parameters (taste, smell, and colour) were part of the analysis.

RESULTS. Two syrup production methods have been developed for industrial pharmacies: technology 1 — based on a sterile sorbitol solution, technology 2 — steri lising the finished product with membrane filtration. For both products, identification and assay of all ingredients was carried out. Neither process parameters (density, pH) nor organoleptic properties (colour, smell, taste) changed within 30 days of storage at a cool place without direct sunlight.

CONCLUSIONS. Two process options have been proposed for sorbitol-based syrup containing water-soluble vitamins C, PP, B₁, B₂, B₆ at concentrations suitable for physiological needs of children aged 1 to 3 years. Both technologies can be used in industrial pharmacies. However, using membrane filtration increases the production net cost, since it uses laboratory equipment in the pharmacy (a vacuum filtration system and a vacuum pump).

1. Starostina LS. Vitamin and mineral supply in children: A pediatrician’s view. Russian Medical Journal. Mother and Child. 2020;3(4):319–25 (In Russ.). https://doi.org/10.32364/2618-8430-2020-3-4-319-325

2. Delyagin VM. Immunity, vitamins, and nutrition. Effective Pharmacotherapy. 2020;16(34):16–19 (In Russ.). https://doi.org/10.33978/2307-3586-2020-16-34-16-19

3. Kosenko VV, Novikov YaS, Egorova SN, et al. Role and safety of excipients in syrups (Review). Regulatory Research and Medicine Evaluation. 2025;15(2):190–205 (In Russ.). https://doi.org/10.30895/1991-2919-2025-15-2-190-205

4. Potekhina TS, Sineva TD. Microbiological aspects of the application of sorbite as the auxiliary substance in the medicines for the children. Problems of Biological, Medical and Pharmaceutical Chemistry. 2010;(4):43– 6 (In Russ.). EDN: MGUOUR

5. Sineva TD, Frolova NYu. Pharmacological aspects of the use of sorbitol as an excipient in medicinal preparations for children. Problems of Biological, Medical and Pharmaceutical Chemistry. 2008;(2):41–5 (In Russ.). EDN: KAJRIP

6. Shishova LI, Yarutkin AV, Bagirowa VL. Current and prospective pharmacopoeial requirements for the quality of extemporaneous medicinal products: a review of regulatory approaches. Regulatory Research and Medicine Evaluation. 2024;14(4):386–99. (In Russ.). https://doi.org/10.30895/1991-2919-2024-14-4-386-399

7. Sutaikina AS, Krishtanova NA, Vishnyakov EV, Sineva TD. Quality assessment of extemporal multivitamin syrup for children: development of analytical techniques. Regulatory Research and Medicine Evaluation. 2024;14(4):411–8 (In Russ.). https://doi.org/10.30895/1991-2919-2024-649

8. Schnellbaecher A, Binder D, Bellmaine S, Zimmer A. Vitamins in cell culture media: Stability and stabilization strategies. Biotechnol Bioeng. 2019;116(6):1537–55. https://doi.org/10.1002/bit.26942