Formulation and clinical evaluation of povidone-iodine ophthalmic drop
01 Aug 2003-Iranian Journal of Pharmaceutical Research (IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR))-Vol. 2, Iss: 3, pp 157-160
TL;DR: This study demonstrated that povidone-iodine in concentration of 2.5% is self-preservative against microbial contamination and desirable to use as a prophylactic agent against ophthalmia neonatorum.
Abstract: Ophthalmia neonatorum is generally defined as conjunctivitis occurring within one month of life. The sources of this infection are environmental organisms or the organisms colonized in the birth canal. Untreated infection can cause blindness, especially if the corresponding organisms are Neisseria gonorrhoeae, or Chlamydia trachomatis. Povidone-iodine ophthalmic solution is an effective antibacterial agent with broad antibacterial and antiviral activity to which no bacterial resistance has been known. It is less expensive and less toxic than the agents currently used to prevent neonatal conjunctivitis. It turns the conjunctiva brown for a few minutes, a characteristic that can serve as an indicator of being properly applied. Because this preparation is not available in Iran, its formulation can be valuable. In this study, the povidone-iodine ophthalmic solution was prepared in concentration of 2.5%, and then required control parameters such as pH, self-preservation effect, tonicity, sterility, and chemical stability were studied. In this clinical study, one drop of povidone-iodine ophthalmic solution was instilled in each eye of 475 neonates within 30 minutes of birth. This study demonstrated that povidone-iodine in concentration of 2.5% is self-preservative against microbial contamination. The pH of solution was adjusted about 5 near to the pH of tear using sodium hydroxide 0.1 N and citric acid 0.5%, because in this pH povidone-iodine was more stable. Tonicity was measured according to an in vitro hemolytic method. Povidone-iodine 2.5% solution was packaged in amber color bottles, and after ensuring from its sterility, it was used in clinical study. Among the population studied, eye discharge was observed in 2.94 percent in comparison to the control group in which eye discharge was observed in 10.9 percent. In conclusion because of availability, low cast, and good clinical results, a 2.5% ophthalmic solution of povidone-iodine is desirable to use as a prophylactic agent against ophthalmia neonatorum.
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TL;DR: A 2.5 percent ophthalmic solution of povidone-iodine as prophylaxis against ophthalmia neonatorum is more effective than treatment with silver nitrate or erythromycin, and it is less toxic and costs less.
Abstract: BACKGROUND
Neonatal conjunctivitis (ophthalmia neonatorum) continues to cause blindness because the agents used prophylactically to prevent this condition are not completely effective and are not widely available in many parts of the world. Povidone-iodine ophthalmic solution is an effective antibacterial agent with broad antibacterial and antiviral activity to which no bacteria are known to be resistant, and it is far less expensive and less toxic than the agents currently used to prevent neonatal conjunctivitis.
METHODS
We conducted a masked, prospective trial involving 3117 infants born over a period of 30 months in a hospital in Kenya. Shortly after birth each infant received a 2.5 percent solution of povidone-iodine (n = 1076), a 1 percent solution of silver nitrate (n = 929), or 0.5 percent erythromycin ointment (n = 1112) in both eyes. Randomization was achieved by rotating the three medications after each was used for a week.
RESULTS
Of the neonates treated with povidone-iodine, 13.1 percent had infectious conjunctivitis, as compared with 17.5 percent of those treated with silver nitrate (P < 0.001) and 15.2 percent of those treated with erythromycin (P = 0.01). Povidone-iodine was more effective against Chlamydia trachomatis than was silver nitrate (P < 0.001) or erythromycin (P = 0.008). There were 104 cases of noninfectious conjunctivitis (9.7 percent) in the povidone-iodine group, as compared with 129 in the silver nitrate group (13.9 percent, P < 0.001) and 148 in the erythromycin group (13.3 percent, P = 0.004). Many cases of noninfectious conjunctivitis were probably due to a toxic reaction to the treatment itself. The incidence of Neisseria gonorrhoeae and Staphylococcus aureus infections was similar in the three groups.
CONCLUSIONS
A 2.5 percent ophthalmic solution of povidone-iodine as prophylaxis against ophthalmia neonatorum is more effective than treatment with silver nitrate or erythromycin, and it is less toxic and costs less.
62 citations
TL;DR: A detailed assessment of bacteria and fungi isolated from the eggs of two blow fly species before and after sterilization by disinfectants Chlorhex-C, povidone-iodine, and sodium hypochlorite reports the survival ability and sterility of larvae and their sterility after the cleansing process.
Abstract: Maggot debridement therapy (MDT) is an application of sterile laboratory-reared blow fly larvae to remove necrotic tissue and disinfect wounds for medical conditions. For effective application, the blow fly larvae used in the wound treatment are required to be in aseptic condition. Here, we report the results of a detailed assessment of bacteria and fungi isolated from the eggs of two blow fly species, Chrysomya megacephala (F.) and Lucilia cuprina (Wiedemann) before and after sterilization by disinfectants Chlorhex-C, povidone-iodine, and sodium hypochlorite. We also assess the survival ability of larvae and their sterility after the cleansing process. The results indicate that the isolated microorganisms from the control group of both the species consisted of 10 species of gram-positive bacteria, 21 species of gram-negative bacteria, and 4 species of yeast. As for sterility testing, the eggs and the larvae of C. megacephala were found to have been completely sterilized after being subjected to thioglycollate medium for 5 days, leading to aseptic larvae. By contrast, some microorganisms from the bacterial culture were still detected in the L. cuprina larvae treated with Chlorhex-C and povidone-iodine. The survival ability of the larvae in both the species was not significantly different between the treated and the control groups. Due to its high disinfection efficacy in destroying microorganisms in both the blow fly eggs, sodium hypochlorite is recommended for preparing sterile larvae before using MDT.
12 citations
TL;DR: In this article, the authors focus on the use of various acids such as citric, acetic, hyaluronic, and hypochlorous acids as topical agents in diabetic foot infections.
Abstract: Management of diabetic foot ulcers is the biggest challenge to the clinician, as conventional antibiotic therapies and local wound care have their own limitations. They are not effective for control of infections and promotion of healing because of cytotoxic effects. In view of cytotoxicity of routinely used topical antiseptic agents, this article focuses on the search of an ideal topical antiseptic agent that is safe and effective in controlling infectious agents and also in promoting the healing process. This review focuses on the use of various acids such as citric, acetic, hyaluronic, and hypochlorous acids as topical agents in diabetic foot infections. This article also focuses on the different roles of acids in the treatment of diabetic foot infections.
5 citations
Patent•
29 Dec 2008
TL;DR: The present invention relates to compositions that contain iodine intended primarily for tissue antisepsis, particularly skin antisepsis as mentioned in this paper, and is related to the present invention of as mentioned in this paper.
Abstract: The present invention relates to compositions that contain iodine intended primarily for tissue antisepsis, particularly skin antisepsis.
4 citations
Journal Article•
TL;DR: There is a statistically significant difference between using HOCL and H2O2 and Povidine iodine as a washing therapy in reducing bacterial count, wound pain, odor, discharge and improve wound healing in diabetic foot ulcer.
Abstract: Introduction: Wound cleansing remains a corner stone in the management of diabetic foot ulcer. Hydrogen Peroxide (H 2 O 2 ) and Povidone Iodine are topical antimicrobial agents but known to be toxic to cells involved in the wound healing cascade. The biggest challenge for the physicians and nurses is searching for a safe, non-cytotoxic and effective wound cleansing as Hypochlorous acid (HOCL). This study aimed to compare the efficacy of HOCL versus H 2 O 2 followed by Povidine Iodine as a wound care agent in treating infected diabetic foot ulcers. Patients and methods: Design: used a randomized clinical trial design to compare the efficacy of HOCL versus H2O2 followed by Povidine Iodine as a wound care agent in treating infected diabetic foot ulcers. Setting: This study was carried out in outpatient plastic and vascular surgery clinic at Assiut university Hospital. Subjects: A random selection was performed on 60 patients with infected diabetic foot ulcers divided equally to control and study group. Methods: HOCL was used for the study group, as irrigate the wound with HOCL in a concentration; sterile Nacl 0.9% to HOCL 50.5% at ratio 8:2 and leave for 5 minutes, before covered the wound with sterile dressing. While H 2 O 2 followed by Povidine Iodine used for the control group and the results were compared. Bacterial cultures were obtained before start washing, after five days thin each five days to the end of the study for the two groups. Results: HOCL was able to be effective against Candida, Proteus, Klebsella, Psudomonas, and Methicillin resistant staphylococcus aureus (MARSA) compare to H2O2 and Povidine iodine. There is a statistically significant difference between using HOCL and H2O2 and Povidine iodine as a washing therapy in reducing bacterial count, wound pain, odor, discharge and improve wound healing in diabetic foot ulcer. Conclusion: Hypochlorous acid is a potent antimicrobial cleanser against a wide range of microorganisms. Hypochlorous Acid is safe, low cost, painless, easy to perform, and improve wound healing or rapidly prepared diabetic foot ulcer for skin flap or graft. Recommendation: The study recommended use of HOCL as a virtuous diabetic wound care cleanser. Further research is needed on a larger scale to validate the effectiveness of Hypochlorous acid as a wound care agent in septic diabetic foot ulcers. Keywords: Hypochlorous Acid, Hydrogen Peroxide, Infected diabetic foot ulcer, Povidine Iodine.
3 citations
References
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Book•
15 Dec 2000
TL;DR: Remington: The Science and Practice of Pharmacy now includes six months free online access to Facts and Comparisons's DrugfactsPlus, the leading source of drug information and pharmacist tools on the Internet.
Abstract: Remington: The Science and Practice of Pharmacy now includes six months free online access to Facts and Comparisons's DrugfactsPlus , the leading source of drug information and pharmacist tools on the Internet. Purchasers of the text will have full online access to A to Z Drug Facts , an alphabetical reference on more than 4,500 medications; Guide to Popular Natural Products , a quick reference on 125 popular medicinal herbs and natural products; Med Facts , a tool that creates patient information handouts on drugs; Drug Identifier , the most complete tool for identifying pills; and a list of over 2,000 drug manufacturers
11,101 citations
TL;DR: In this article, a masked, prospective trial involving 3117 infants born over a period of 30 months in a hospital in Kenya was conducted, where each infant received a 2.5 percent solution of povidone-iodine (n = 1076), a 1 percent Solution of silver nitrate (N = 929), or 0.5 Percent erythromycin ointment (N= 1112) in both eyes.
Abstract: Background Neonatal conjunctivitis (ophthalmia neonatorum) continues to cause blindness, because the agents used prophylactically to prevent this condition are not completely effective and are not widely available in many parts of the world. Povidone–iodine ophthalmic solution is an effective antibacterial agent with broad antibacterial and antiviral activity to which no bacteria are known to be resistant, and it is far less expensive and less toxic than the agents currently used to prevent neonatal conjunctivitis. Methods We conducted a masked, prospective trial involving 3117 infants born over a period of 30 months in a hospital in Kenya. Shortly after birth each infant received a 2.5 percent solution of povidone–iodine (n = 1076), a 1 percent solution of silver nitrate (n = 929), or 0.5 percent erythromycin ointment (n = 1112) in both eyes. Randomization was achieved by rotating the three medications after each was used for a week. Results Of the neonates treated with povidone–iodine, 13.1 percent had ...
147 citations
98 citations
Journal Article•
01 Mar 1985-Journal of parenteral science and technology : a publication of the Parenteral Drug Association
TL;DR: Two in vitro methods are presented which enable the evaluation of virtually any solution for the production of lysis in intramuscular and intravenous administration and the effects of vehicle components on the absorbance or solubility of hemoglobin are virtually eliminated.
Abstract: Two in vitro methods are presented which enable the evaluation of virtually any solution for the production of lysis in intramuscular and intravenous administration. These methods differ from the standard hemolytic method in that the RBCs and ghosts, which remain after mixing test solution with RBCs, are washed with normal saline. The intact RBCs are then lysed with water. Since the final measurement is always made in pure water, the effects of vehicle components on the absorbance or solubility of hemoglobin are virtually eliminated. These methods were used to evaluate propylene glycol (PG), dimethyl sulfoxide (DMSO), ethanol (EtOH), polyethylene glycol 400 (PEG 400), dimethyl acetamide (DMA), and dimethyl isosorbide (DMI) for hemolytic potential in comparison to a reference of 10% EtOH, 40% PG, and 50% water. Measured LD 50 values for lysis of RBCs are expressed as total volume percent of cosolvent in whole blood. These values are: 39.5% DMI, 37.0% DMA, 30.0% PEG 400, 21.2% EtOH, 10.3% reference, 5.7% PG, and 5.1% DMSO.
64 citations
TL;DR: A 2.5 percent ophthalmic solution of povidone-iodine as prophylaxis against ophthalmia neonatorum is more effective than treatment with silver nitrate or erythromycin, and it is less toxic and costs less.
Abstract: BACKGROUND
Neonatal conjunctivitis (ophthalmia neonatorum) continues to cause blindness because the agents used prophylactically to prevent this condition are not completely effective and are not widely available in many parts of the world. Povidone-iodine ophthalmic solution is an effective antibacterial agent with broad antibacterial and antiviral activity to which no bacteria are known to be resistant, and it is far less expensive and less toxic than the agents currently used to prevent neonatal conjunctivitis.
METHODS
We conducted a masked, prospective trial involving 3117 infants born over a period of 30 months in a hospital in Kenya. Shortly after birth each infant received a 2.5 percent solution of povidone-iodine (n = 1076), a 1 percent solution of silver nitrate (n = 929), or 0.5 percent erythromycin ointment (n = 1112) in both eyes. Randomization was achieved by rotating the three medications after each was used for a week.
RESULTS
Of the neonates treated with povidone-iodine, 13.1 percent had infectious conjunctivitis, as compared with 17.5 percent of those treated with silver nitrate (P < 0.001) and 15.2 percent of those treated with erythromycin (P = 0.01). Povidone-iodine was more effective against Chlamydia trachomatis than was silver nitrate (P < 0.001) or erythromycin (P = 0.008). There were 104 cases of noninfectious conjunctivitis (9.7 percent) in the povidone-iodine group, as compared with 129 in the silver nitrate group (13.9 percent, P < 0.001) and 148 in the erythromycin group (13.3 percent, P = 0.004). Many cases of noninfectious conjunctivitis were probably due to a toxic reaction to the treatment itself. The incidence of Neisseria gonorrhoeae and Staphylococcus aureus infections was similar in the three groups.
CONCLUSIONS
A 2.5 percent ophthalmic solution of povidone-iodine as prophylaxis against ophthalmia neonatorum is more effective than treatment with silver nitrate or erythromycin, and it is less toxic and costs less.
62 citations