ДОСЛІДЖЕННЯ СТАБІЛЬНОСТІ ПРЕПАРАТУ «КОРВАЛОЛ» У ФОРМІ СУБЛІНГВАЛЬНИХ ТАБЛЕТОК

Анотація

Introduction. In today's world, oral tablets is the most convenient and widely used in medical practice dosage form. The patients prefers solid dosage forms due to their ease of transportation, capability of self-dosage drug dose and painless application. However, some categories of patients, especially elderly patients, have difficulties in swallowing dosage forms in the solid form. For these categories of patients developed sublingual tablet form - a drug that combines practicality and convenience of the pill and dissolves quickly in the mouth and easily enters the gastrointestinal tract. In addition, numerous clinical studies have shown that the therapeutic effect for sublingual tablets comes earlier than for traditional tablets that dissolve in the stomach of the patient because drug absorption through the mucous begins immediately after oral administration. [1-4].

"Korvalol" drops used for treatment of temporary nervous system disorders, disorders of the autonomic nervous system, cardiovascular system, spastic pain [5]. The product is aimed for the elderly patients, for whom need immediate help, so the most appropriate is development sublingual tablets, similar to "Korvalol" drops.

For drugs used in medical practice in addition to the requirements of efficiency and safety are increased pharmacopoeial requirements for quality. Drugs should remain effective throughout the all period of storage, so stability is one of the main requirements for the quality of drugs [6].

The purpose of these studies was stability studies and determining the shelf life of the drug "Korvalol" in the form of sublingual tablets during the long-term storage.

Materials and Methods:

Stability studies conducted for three pilot batches: 10910, 20910, 30910 for sublingual tablets "Korvalol" manufactured on JSC "Farmak". Tests were conducted for tablets in the package for sale (polyvinyl chloride light-shielded film and aluminum foil with printing). To determine the shelf life long-term stability researches were conducted at a temperature of 15 to 25⁰C and relative humidity of 60 ± 5%, control points were 0, 3, 6, 9, 12, 18, 24 months. The study of accelerated stability was conducted at 40 ±2⁰C and relative humidity of 75 ± 5%, control points were 0, 3, 6 months.

Results and discussion

As a result, the study found that during two years of storage in the original packaging at a temperature of 15 to 250C and relative humidity of 60 ± 5% three researched batches of sublingual tablets "Korvalol" showed formulation stability throughout all of the period. Quantitative and qualitative indicators of the quality of the drug are within acceptable norms throughout all of the studied period.

Packaging provides protection from external influence of the drug, microbiological parameters did not change and fully meet the requirements of the specification.

Results of the study of long-term stability demonstrate the rationality of the drug composition, and optimal manufacturing technology. Excipients were chosen according to technological, physico-chemical and functional characteristics.

Conclusions

• Researched long-term and accelerated stability of sublingual tablets "Korvalol"
• Physicochemical and pharmacological studies of sublingual tablets "Korvalol" completed. The research results are included to the specification of the drug.
• Proved stability of the drug in the proposed package for two years storage at a temperature of 15 to 25⁰C and relative humidity of 60 ± 5%.