SOLID ORAL FORM OF A MEDICINAL PREPARATION AND A METHOD FOR THE PRODUCTION THEREOF

Abstract

A solid dosage form of an antibody-based medicinal preparation comprising an effective amount of a carrier treated with a dilution containing at least one antibody to a biologically active molecule.

Claims

1.-9. (canceled)

10. A solid dosage form for administration to a human subject, said dosage form comprising an effective amount of a pharmaceutically neutral carrier treated with a homeopathic dilution of an initial solution containing at least one antibody to a biologically-active molecule.

11. The solid dosage form of claim 10, wherein said initial solution is obtained by i) generating an immune response to said biologically-active molecule in a host external to said human subject thereby generating said antibody in said host, and ii) isolating said generated antibody from said host.

12. The solid dosage form of claim 10, wherein said biologically-active molecule is endogenous to said human subject.

13. The solid dosage form of claim 12, wherein said biologically-active molecule plays a role in regulation of pathological syndrome for said human.

14. The solid dosage form of claim 12, wherein said biologically-active molecule affects formation of pathological syndrome for said human.

15. The solid dosage form of claim 10, wherein said homeopathic dilution is prepared by successive dilutions.

16. The solid dosage form of claim 15, wherein said homeopathic dilution is prepared by combining said successive dilutions with external treatment.

17. The solid dosage form of claim 16, wherein said external treatment is mechanical shaking, ultrasonic treatment, or electromagnetic field treatment.

18. The solid dosage form of claim 10, wherein said carrier is lactose.

19. The solid dosage form of claim 18, which is in the form of a tablet.

20. The solid dosage form of claim 19, wherein said carrier comprises from 30% to 80% by weight with respect to total weight of said dosage form.

21. The solid dosage form of claim 20, further comprising a binder and a lubricant.

22. The solid dosage form of claim 21, wherein said lubricant comprises from 0.8% to 1.2% by weight with respect to total weight of said dosage form.

23. The solid dosage form of claim 21, wherein said binder comprises from 10% to 15% by weight with respect to total weight of said dosage form.

24.-28. (canceled)

29. The solid oral dosage form of claim 11, wherein said isolating step provides an isolate containing said at least one antibody.

30. The solid oral dosage form of claim 29, wherein said initial solution contains 0.05 to 3% of said isolate.

31. (canceled)

Description

EXAMPLE 1

[0043] Patient V., 19 years old. Administers himself with heroin by inhalation at least 3 times a week for 2 months. Based on parental consent, the patient was hospitalized and placed in isolated unit for 24 days. 2 days after admission the patient became irritable and developed sleep disturbance. During conversation, mentioned that he noticed attraction to narcotics. Prescribed: 1 tablet saturated with potentiated antibodieshomeopathic dilution C30 of the -globulin fraction of antiserum to morphine hydrochloride6 times a day. 3 weeks later the patient demonstrated steady mood, satisfactory appetite and sleep. During individual session with psychologist, the patient stated that he experienced no attraction. Recommended to continue taking heroin antibodies on a daily basis at 1 tablet a day. 2 months after discharging from the hospital, according to his mother, the patient does not take any narcotics.

EXAMPLE 2

[0044] Patient K., 57 years old, suffering from rheumatoid arthritis (RA) for 5 years, class III according to functional classification of the American College of Rheumatology, and was hospitalized due to exacerbation of the disease. Upon admission: complaints about fever, considerable increase in morning stiffness and pain in affected joints, their inflammation. Objectively: temperature 37.5 C., pronounced hyperemia and defiguration of wrist, ankle and proximal interphalangeal joints, pain during palpation. In blood test: ESR 35 mm/h, rheumatoid factor++. Due to poor tolerance of non-steroid anti-inflammatory drugs, prescribed: 1 tablet saturated with potentiated antibodiesa mixture of homeopathic dilutions C50, C200 (1:1) of monoclonal antibodies to recombinant human tumor necrosis factor alpha3 times a day. 3 days after the beginning of treatment, the patient observed considerable reduction in pain syndrome, body temperature dropped to normothermia. On the 7.sup.th day of treatment: morning stiffness observed before hospitalization still remains. The patient was discharged on the 14.sup.th day with the clinical-laboratory remission. Recommended prophylactic administration of the drug by taking 1 tablet every other day. 2 months after discharge, the patient's class is changed from III to II according to RA functional classification.

EXAMPLE 3

[0045] Patient S., 51 years old, came to see urologist with complains about decrease in libido, erection abnormality, lower satisfaction from sexual intercourse. Mentioned symptoms intensified over the past 2 years. During the last 3 years also observed occasional depression, grizzle, memory impairment and sleep disturbance, decrease in ability to work, palpitation attacks, fluctuations in arterial blood pressure. Objectively: revealed moderate enlargement of prostate gland. Diagnosis: erectile dysfunction with involutional hormonal changes. Prescribed: 1 tablet saturated with potentiated antibodiesa mixture of homeopathic dilutions of monoclonal antibodies to a fragment of human endothelium NO synthase D6, C30 and C200 (1:1:1)once every 3 days. 2 weeks after the beginning of treatment, the patient demonstrated improvement in erection and increase in libido along with general improvement in health condition: higher overall tonus, better sleep. Recommended taking medicine 1-2 times a week. During follow-up visit 2 months after the beginning of treatment, the patient expressed no previous complaints, observed recovery in libido level, erection and satisfaction from the intercourse.