KR20030020137A - Dry syrup containing ribavirin - Google Patents

Dry syrup containing ribavirin Download PDF

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KR20030020137A
KR20030020137A KR1020010053815A KR20010053815A KR20030020137A KR 20030020137 A KR20030020137 A KR 20030020137A KR 1020010053815 A KR1020010053815 A KR 1020010053815A KR 20010053815 A KR20010053815 A KR 20010053815A KR 20030020137 A KR20030020137 A KR 20030020137A
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ribavirin
dry syrup
oral administration
stability
drug
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이용화
노재일
이주영
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진양제약주식회사
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals

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  • Chemical & Material Sciences (AREA)
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  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • General Health & Medical Sciences (AREA)
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Abstract

PURPOSE: A dried syrup of ribavirin for oral administration is provided. It can be easily dissolved just before its oral administration, rapidly shows its pharmacological efficacy, maintains concentration of ribavirin constant in vivo, and has no bitter taste or bad smell. Therefore, children and old people can easily take it. CONSTITUTION: The dried syrup of ribavirin for oral administration comprises 0.5 to 5.0% of ribavirin, 0.1 to 5.5% of sodium starch glycolate, 0.5 to 5.5% of hydroxypropylmethylcellulose 2910, 0.05 to 0.5% of xanthan gum, 2.0 to 40.0% of D-mannitol, and 40.0 to 90.0% of refined sugar, wherein the dried syrup of ribavirin for oral administration is prepared by using ribavirin, diluents, sweeteners and suspensions.

Description

리바비린 건조시럽제 {Dry syrup containing ribavirin}Ribavirin dry syrup {Dry syrup containing ribavirin}

본 발명은 안정성이 확보되고, 간편한 복용, 용량조절의 수월성, 생체이용률(20 ∼ 50%)의 향상을 기대할 수 있고, 포진바이러스 뿐만 아니라 소아의 호흡기질환, 소아나 성인의 인플루엔자 A(influenza A)에도 효과가 있는 리바비린(Ribavirin)의 새로운 경구용 건조시럽제에 관한 것이다.The present invention is stable, easy to take, easy to adjust the dose, can be expected to improve the bioavailability (20 to 50%), respiratory diseases of children, influenza A (influenza A) of children and adults as well as herpes virus It relates to a new oral dry syrup of Ribavirin that is also effective.

리바비린은 다음의 구조식 (I)로 표시되는 공지물질로 항바이러스 효능을 가지는 물질이다.Ribavirin is a known substance represented by the following structural formula (I) and is a substance having antiviral efficacy.

(I) (I)

리바비린은 인체 세포내(in vitro)에 기생하는 RNA 바이러스와 DNA 바이러스의 분열, 증식 또는 잠복감염을 효과적으로 억제하고 치료하는 약물이다. 가장 흔한 감염성 질환의 하나로서 포진바이러스(Herpesviruses)종류에 속하는 Herpes simplex virus(HSV)에 의해 발생하는 음부포진의 경우, 주로 남녀 성기부위에 발생하는 성병중의 하나로 임질보다 약 10배정도 더 많은 것으로 보고되어 있으며 국내의 환자수도 증가추세에 있으며, HSV외에 아이들과 폐경후 여성들의 질내에 염증을 일으키는 질염(Vaginitis)의 하나인 Cytomegalovirus도 보고 되고 있다.Ribavirin is a drug that effectively inhibits and treats the division, proliferation or latent infection of RNA viruses and DNA viruses that are parasitic in human cells in vitro. Genital herpes caused by Herpes simplex virus (HSV), a type of herpesviruses, is one of the most common sexually transmitted diseases of the genital area of men and women, and is reported to be about 10 times more than gonorrhea. The number of patients in Korea is also increasing, and besides HSV, Cytomegalovirus, a vaginitis that causes inflammation in the vagina of children and postmenopausal women, has been reported.

호흡기 질환(Respiratory Syncytial Virus)은 소아에 있어 폐렴을 일으키기 쉬우므로 소아에게 매우 치명적이다. 포진바이러스뿐만 아니라 이러한 유아의 호흡기 질환에 매우 효과적인 항바이러스 치료제 리바비린은 DNA뿐만 아니라 RNA 바이러스를 억제시킨다.Respiratory Syncytial Virus is very deadly in children because it is easy to cause pneumonia in children. As well as herpes viruses, the antiviral drug ribavirin, which is very effective in respiratory diseases in infants, inhibits RNA as well as DNA.

대부분 RNA 바이러스들은 면역계가 방해하거나 백신을 투여하면 막을 수 있지만, 어떤 것들은 DNA 바이러스와 달리 아주 재빨리 적응을 해서 준종(quasispecies)이 되고, 그러면 면역 계로나 백신으로도 막을 수가 없다. 대개 RNA는 DNA에 비해 불안정한데 오히려 이런 점이 바이러스에게는 돌연 변이를 잘 일으켜서 면역계를 피할 수 있는 장점이 될 수 있다. Ribavirin은 유전적 수준에서 작용해서 돌연변이를 일으키고 게놈(genome)을 바꾸어놓아 미묘한 균형을 깨뜨림으로써, 바이러스의 작용을 억제하고 스스로 죽도록 만든다. 그러나 이 약물은 보관 및 투여에 어려움이 많다. 또한 이 약은 흡수율이 낮아 체내에 유효농도를 일정하게 유지시키기가 어려워 용량에 따른 효과를 예측하기도 매우 어렵다.Most RNA viruses can be blocked by the immune system or prevented by vaccines, but some can adapt very quickly to DNA and become quasi-pecies, unlike the immune system or vaccine. Usually, RNA is unstable compared to DNA, but this can be a good mutation for viruses, which can be an advantage of avoiding the immune system. Ribavirin acts at the genetic level, causing mutations and altering the genome, breaking the delicate balance, causing the virus to act and kill itself. However, the drug is difficult to store and administer. It also has a low absorption rate, making it difficult to maintain a constant effective concentration in the body, making it difficult to predict the effects of dose.

보통 성인 1회 100 ∼ 200 mg을 1일 6 ∼ 8시간마다 3 ∼ 4회 투여하고 소아는 1일 10mg/kg을 3 ∼ 4회 분할 경구 투여하는 등 상당히 번거로워 복용하는데 많은 어려움이 있었다. 따라서 간편한 복용, 용량조절의 수월성, 생체 이용률의 향상을 기대할 수 있는 새로운 제제의 개발이 필요하게 되었다.In general, 100 to 200 mg of an adult is administered 3 to 4 times every 6 to 8 hours a day, and children have a lot of difficulty in taking a lot of trouble such as oral administration of 3 to 4 divided doses of 10 mg / kg per day. Therefore, there is a need for the development of a new formulation that can be expected to be easy to take, easy to adjust the dose, and improved bioavailability.

본 발명은 전술한 필요성에 의하여 리바비린의 새로운 제제로서 경구용 건조시럽제에 관한 것이다. 건조시럽제는 투여 직전에 약물을 완전히 녹이거나 일정하게 분산시킨 제형으로, 약물효과가 신속히 나타나길 기대할 수 있고, 개체의 약물 용해도 차이에 의한 생체이용율 차이를 줄여줄 수 있어 기대하는 약효를 일정하게 유지할 수 있는 특징이 있다.The present invention relates to a dry oral syrup for oral use as a new formulation of ribavirin by the aforementioned needs. Dried syrup is a formulation in which the drug is completely dissolved or uniformly dispersed immediately before administration, and the drug effect can be expected to be rapid, and the difference in bioavailability due to the difference in the drug solubility of the individual can be reduced, so that the expected drug efficacy can be kept constant. There is a characteristic.

본 발명자들은 이러한 목표를 달성하기 위하여 경구용 리바비린 건조시럽제 개발을 연구하였고, 안정화 연구를 통하여 안정성이 확보되는 새로운 경구용 Ribavirin 건조시럽제 개발에 성공하였다.The present inventors studied the development of oral ribavirin dry syrup for oral use, and succeeded in developing a new oral Ribavirin dry syrup for securing stability through stabilization studies.

따라서, 본 발명의 목적은 안정성이 확보되고, 간편한 복용, 용량조절의 수월성, 생체 이용율의 향상을 기대할 수 있는 새로운 제제로서 경구용 리바비린 건조시럽제를 제공하는 것이다.Therefore, it is an object of the present invention to provide oral ribavirin dry syrup for oral administration as a new formulation that can ensure stability, ease of taking, easy dosing control, and improved bioavailability.

본 발명의 또다른 목적은 리바비린을 주성분으로 함유하는 경구용 리바비린 건조시럽제의 조성물을 제공하는 것이다.Another object of the present invention is to provide a composition of oral ribavirin dry syrup containing ribavirin as a main component.

도 1은 리바비린(Ribavirin) 건조시럽제에 대한 HPLC이다.1 is HPLC for Ribavirin dry syrup.

본 발명에서는, 건조시럽제 제조에 필요한 용매계의 스크리닝을 통하여 약물의 안정성을 확보할 수 있는 용매 및 보존제 등의 조성을 찾아내는 설계작업을 시행하였다.In the present invention, the design work to find the composition of the solvent and the preservative to ensure the stability of the drug through the screening of the solvent system required for the preparation of the dry syrup was carried out.

이를 위하여 각각 다른 pH 조건과 기본 첨가제가 첨가된 용매계에서 약물의 안정성 경향, 용매계와의 상호작용 및 용해도에 관한 연구를 수행하였다. 이 결과를 이용하여 경구용 리바비린의 건조시럽제에 적합한 제제를 설계하였다.To this end, studies were conducted on the stability trends of the drugs, interactions with the solvent systems, and solubility in solvent systems to which different pH conditions and basic additives were added. This result was used to design a formulation suitable for dry syrup of oral ribavirin.

기본적인 액제의 처방을 확정하고, 이 처방중에서의 안정성이 확인된 처방을 이용하여 약물의 안정성을 향상시킬수 있는 처방 변경을 시도하였다. 얻어진 처방에 감미와 방향성을 목적으로 감미제와 방향성 첨가제를 여러 가지 가하여 가장 적합한 물질을 선택하였다. 이상의 실험을 통하여 리바비린, 부형제, 감미제 및 현탁화제로 이루어진 통상의 방법으로 리바비린 건조시럽제를 제조하였으며, 건조시럽제의 조성은 리바비린 0.5 ∼ 5.0%, 글리콜산전분나트륨 0.1 ∼ 5.5%, 히드록시프로필메칠셀룰로오스 2910 0.5 ∼ 5.5%, 잔탄검 0.05 ∼ 0.5%, D-만니톨 2.0 ∼ 40.0% 및 백당 40.0 ∼ 90.0%로 이루어지고, 여기에 안정화제, 방향제 및 착색제 등을 첨가하였다. 실시예 및 결과를 표 1에 나타내었다. 그러나, 다음의 실시예가 본 발명을 한정하는 것은 아니다.The prescription of basic liquid formulation was confirmed, and the prescription which confirmed the stability in this prescription was used, and the prescription change which can improve the stability of drug was tried. Various sweeteners and fragrance additives were added to the obtained formulations for the purpose of sweetening and fragrance to select the most suitable substance. Through the above experiments, the ribavirin dry syrup was prepared by a conventional method consisting of ribavirin, excipients, sweeteners and suspending agents. 2910 0.5 to 5.5%, xanthan gum 0.05 to 0.5%, D-mannitol 2.0 to 40.0%, and 40.0 to 90.0% per bag, to which stabilizers, fragrances and coloring agents were added. Examples and results are shown in Table 1. However, the following examples do not limit the present invention.

경구용 리바비린 건조시럽제 제형설계 실험 및 평가Experimental Design and Evaluation of Oral Ribavirin Dry Syrup Formulation 성분 실시예(100g/150ml)Ingredient Example (100 g / 150 ml) 1One 22 33 44 55 66 77 RibavirinRibavirin 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5 SSGSSG 0.50.5 0.50.5 0.50.5 0.50.5 AvicelAvicel 0.50.5 0.50.5 HPMC2910HPMC2910 2.02.0 2.02.0 1.51.5 1.51.5 1.51.5 1.51.5 1.51.5 Xanthan gumXanthan gum 0.30.3 0.30.3 0.150.15 0.150.15 0.150.15 0.150.15 0.150.15 D-mannitolD-mannitol 21.9921.99 19.9919.99 25.3425.34 25.3425.34 25.1925.19 25.1425.14 24.9424.94 SucroseSucrose 72.072.0 54.054.0 70.070.0 70.070.0 70.070.0 70.070.0 70.070.0 DextrinDextrin 20.020.0 Citric acidCitric acid 0.20.2 0.20.2 0.150.15 0.150.15 Sod. ChlorideSod. Chloride 0.50.5 0.50.5 Sodium citrateSodium citrate 0.200.20 0.250.25 Sod. Lauryl Sul.Sod. Lauryl Sul. 0.50.5 Yellow 203Yellow 203 0.010.01 0.010.01 0.010.01 0.010.01 0.010.01 0.010.01 0.010.01 Orange coatonOrange coaton 1.01.0 1.01.0 1.01.0 1.01.0 1.01.0 1.01.0 1.01.0 TotalTotal 100.0100.0 100.0100.0 100.0100.0 100.0100.0 100.0100.0 100.0100.0 100.0100.0 결과 및 평가Results and rating 점도가큼High viscosity 점도가크고,맛이 산뜻하지 못함Viscosity is large, taste is not refreshing 점도양호거품발생Viscosity good foam generation 농도양호분리pH 4.1Concentration Good Separation pH 4.1 점도양호pH 3.1Good viscosity 3.1 점도양호pH 6.3Good viscosity pH 6.3 점도양호pH 4.5Good viscosity pH 4.5

상기의 실시예중에서 실시예 7이 점도, pH, 맛, 균일정도 등에서 가장 안정적인 결과를 얻었다. 따라서 실시예 7의 리바비린 건조시럽제를 일주일 간격으로 각각 제조하여 가혹조건에서 안정성을 평가하기 위해 온도 40도, 습도 75%에서 2, 4, 6개월간 가속시험을 통하여 물리화학적 성상, pH 및 리바비린 함량을 측정하였다. 위의 실험결과를 표 2에 나타내었다.Of the above examples, Example 7 obtained the most stable results in viscosity, pH, taste, uniformity, and the like. Therefore, the ribavirin dry syrup of Example 7 was prepared at weekly intervals to evaluate the stability under severe conditions. Measured. The above experimental results are shown in Table 2.

시험항목Test Items 기준standard 제조번호Manufacturing number 제조일자Date of Manufacture 시험결과Test result 조제시Preparation 2개월2 months 4개월4 months 6개월6 months 성상Constellation 미황색 가루Light yellow powder RB001RB001 00. 10. 1100. 10. 11 적합fitness 적합fitness 적합fitness 적합fitness RB002RB002 00. 10. 1800. 10. 18 적합fitness 적합fitness 적합fitness 적합fitness RB003RB003 00. 10. 2500. 10. 25 적합fitness 적합fitness 적합fitness 적합fitness 확인Confirm 표준액과동일한 Rf값과색상의 반점을 나타냄Rf value and same color spot as standard solution RB001RB001 00. 10. 1100. 10. 11 적합fitness 적합fitness 적합fitness 적합fitness RB002RB002 00. 10. 1800. 10. 18 적합fitness 적합fitness 적합fitness 적합fitness RB003RB003 00. 10. 2500. 10. 25 적합fitness 적합fitness 적합fitness 적합fitness pHpH 3.3 - 5.53.3-5.5 RB001RB001 00. 10. 1100. 10. 11 4.54.5 4.44.4 4.54.5 4.34.3 RB002RB002 00. 10. 1800. 10. 18 4.44.4 4.44.4 4.54.5 4.34.3 RB003RB003 00. 10. 2500. 10. 25 4.54.5 4.34.3 4.34.3 4.44.4 리바비린Ribavirin 95.0 - 105.0%95.0-105.0% RB001RB001 00. 10. 1100. 10. 11 99.2599.25 99.8899.88 99.5699.56 98.9298.92 RB002RB002 00. 10. 1800. 10. 18 99.9799.97 100.01100.01 99.5699.56 99.1199.11 RB003RB003 00. 10. 2500. 10. 25 100.04100.04 99.7499.74 98.9198.91 99.3199.31

* pH(3.5 - 5.5) : 100g을 물에 현탁시켜 150ml로 하여 pH 측정.* pH (3.5-5.5): 100g suspended in water to 150ml to measure the pH.

온도변화에 따른 리바비린의 함량변화Change in Ribavirin Content with Temperature 항목Item 정량법Assay 규격standard 시험조건Exam conditions 제조번호Manufacturing number 6개월보존6 months storage 판정Judgment RibavirinRibavirin HPLCHPLC 95.0- 105.0%95.0-105.0% -20℃-20 ℃ RB001RB001 100.03100.03 안정stability RB002RB002 98.9498.94 안정stability RB003RB003 99.6599.65 안정stability 5℃5 ℃ RB001RB001 99.4799.47 안정stability RB002RB002 98.7398.73 안정stability RB003RB003 100.34100.34 안정stability 20℃20 ℃ RB001RB001 98.9698.96 안정stability RB002RB002 99.8299.82 안정stability RB003RB003 99.2199.21 안정stability

HPLC 조건 : (Column : Spherisorb ODS 25cm, Detector : UV 207nm, Mobile Phase : MeOH·H2O (1:1), Injection volume : 10㎕, Flow rate : 1.0ml/min, )HPLC condition: (Column: Spherisorb ODS 25cm, Detector: UV 207nm, Mobile Phase: MeOHH 2 O (1: 1), Injection volume: 10µl, Flow rate: 1.0ml / min,)

본 발명은 복용하기가 어렵고 생체 농도를 적절히 유지하는데 어려움이 있었던 항바이러스 약물인 리바비린을 건조시럽제로 만들어, 쉽게 용해 현탁되고, 약물효과가 신속히 나타날 수 있고, 정제 투여시 개체의 약물 용해도 차이에 의해 야기될 수 있는 생체이용율 차이도 줄여줄 수 있어 약효가 일정하게 유지될 수 있다. 또한, 경구투여시 약물에 대한 불쾌감이 전혀 없어 환자들의 약에 대한 순응도가 높아져 소아나 노인들에게도 쉽게 투여할 수 있을 것으로 기대된다.The present invention provides a dry syrup of an antiviral drug, ribavirin, which is difficult to take and difficult to maintain a proper bioconcentration, can be easily dissolved and suspended, and the drug effect can be manifested quickly. The difference in bioavailability that can be caused can also be reduced so that the drug efficacy can be kept constant. In addition, oral administration is expected to be easily administered to children and the elderly as there is no discomfort for the drug and the patient's compliance with the drug is increased.

Claims (2)

리바비린, 부형제, 감미제 및 현탁화제로 통상의 약제학적인 방법으로 제조된 리바비린 건조시럽제.Ribavirin dry syrup prepared by conventional pharmaceutical methods of ribavirin, excipients, sweetening agents and suspending agents. 제 1항에 있어서, 리바비린 0.5 ∼ 5.0%, 글리콜산전분나트륨 0.1 ∼ 5.5%, 히드록시프로필메칠셀룰로오스 2910 0.5 ∼ 5.5%, 잔탄검 0.05 ∼ 0.5%, D-만니톨 2.0 ∼ 40.0% 및 백당 40.0 ∼ 90.0%를 함유하는 리바비린 건조시럽제 조성물.The method according to claim 1, wherein 0.5 to 5.0% of ribavirin, 0.1 to 5.5% of sodium starch glycolate, 0.5 to 5.5% of hydroxypropylmethylcellulose, 0.05 to 0.5% of xanthan gum, 2.0 to 40.0% of D-mannitol, and 40.0 to white sugar A ribavirin dry syrup composition containing 90.0%.
KR1020010053815A 2001-09-03 2001-09-03 Dry syrup containing ribavirin KR20030020137A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5535047A (en) * 1978-09-06 1980-03-11 Asahi Chem Ind Co Ltd Dry syrup
US5767097A (en) * 1996-01-23 1998-06-16 Icn Pharmaceuticals, Inc. Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes
WO1999032128A1 (en) * 1997-12-22 1999-07-01 Schering Corporation Orally administrable solid ribavirin dosage forms and process for making them

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5535047A (en) * 1978-09-06 1980-03-11 Asahi Chem Ind Co Ltd Dry syrup
US5767097A (en) * 1996-01-23 1998-06-16 Icn Pharmaceuticals, Inc. Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes
WO1999032128A1 (en) * 1997-12-22 1999-07-01 Schering Corporation Orally administrable solid ribavirin dosage forms and process for making them
US6051252A (en) * 1997-12-22 2000-04-18 Schering Corporation Orally administrable solid dosage form

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