Technology for Triple Fortification of Salt with Folic Acid, Iron, and Iodine.

As many of the maternal and child health complications result from folic acid, iron, and iodine deficiencies; it makes sense to combat these simultaneously. We have developed cost-effective technology to deliver these three micronutrients simultaneously through salt. Our goal was to retain at least 70% of the micronutrients during 6 months of storage. The fortified salt was formulated by spraying a solution that contained 2% iodine and 0.5% or 1% folic acid onto salt and adding encapsulated ferrous fumarate. The formulated triple fortified salt contained 1,000 ppm iron, 50 ppm iodine, and 12.5 or 25 ppm folic acid. The spray solution and the salt were stored for 2 and 6 months respectively at 25, 35, and 45 °C 60 to 70% relative humidity. Even at 45 °C, over 70% of both iodine and folic acid were retained in the salt. The best formulation based on the color of the salt and stability of iodine and folic acid contained 12.5 ppm folic acid, 50 ppm iodine, and 1,000 ppm iron. These results indicate that iron, iodine, and folic acid can be simultaneously delivered to a vulnerable population through salt using the technology described. Also, the quality control of the process can be developed around pteroic acid that was detected as a primary degradation product of folic acid. PRACTICAL APPLICATION: The technology developed is already transferred to India for industrial scale up. When fully operational, the technology will simultaneously solve iron, iodine, and folic acid deficiencies in vulnerable populations at a very low cost.

Nanostructured cochleates: a multi-layered platform for cellular transportation of therapeutics.

Among lipid-based nanocarriers, multi-layered cochleates emerge as a novel delivery system because of prevention of oxidation of hydrophobic and hydrophilic drugs, enhancement in permeability, and reduction in dose of drugs. It also improves oral bioavailability and increases the safety of a drug by targeting at a specific site with less side effects. Nanostructured cochleates are used as a carrier for the delivery of water-insoluble or hydrophobic drugs of anticancer, antiviral and anti-inflammatory action. This review article focuses on different methods for preparation of cochleates, mechanism of formation of cochleates, mechanism of action like cochleate undergoes macrophagic endocytosis and release the drug into the systemic circulation by acting on membrane proteins, phospholipids, and receptors. Advanced methods such as calcium-substituted and ß-cyclodextrin-based cochleates, novel techniques include microfluidic and modified trapping method. Cochleates showed enhancement in oral bioavailability of amphotericin B, delivery of factor VII, oral mucosal vaccine adjuvant-delivery system, and delivery of volatile oil. In near future, cochleate will be one of the interesting delivery systems to overcome the stability and encapsulation efficiency issues associated with liposomes. The current limiting factors for commercial preparation of cochleates involve high cost of manufacturing, lack of standardization, and specialized equipments.

Mucuna pruriens for Parkinson's disease: Low-cost preparation method, laboratory measures and pharmacokinetics profile.

BACKGROUND: Parkinson's disease (PD) is a progressive neurological condition. Levodopa (LD) is the gold standard therapy for PD patients. Most PD patients in low-income areas cannot afford long-term daily Levodopa therapy. The aim of our study was to investigate if Mucuna pruriens (MP), a legume with high LD content that grows in tropical regions worldwide, might be potential alternative for poor PD patients. METHODS: We analyzed 25 samples of MP from Africa, Latin America and Asia. We measured the content in LD in various MP preparations (dried, roasted, boiled). LD pharmacokinetics and motor response were recorded in four PD patients, comparing MP vs. LD+Dopa-Decarboxylase Inhibitor (DDCI) formulations. RESULTS: Median LD concentration in dried MP seeds was 5.29%; similar results were obtained in roasted powder samples (5.3%), while boiling reduced LD content up to 70%. Compared to LD+DDCI, MP extract at similar LD dose provided less clinical benefit, with a 3.5-fold lower median AUC. CONCLUSION: Considering the lack of a DDCI, MP therapy may provide clinical benefit only when content of LD is at least 3.5-fold the standard LD+DDCI. If long-term MP proves to be safe and effective in controlled clinical trials, it may be a sustainable alternative therapy for PD in low-income countries.

Budget impact assessment of Aprokam® compared with unlicensed cefuroxime for prophylaxis of post-cataract surgery endophthalmitis.

BACKGROUND: Intracameral cefuroxime is recommended as prophylaxis against postoperative endophthalmitis (POE) following cataract surgery. Aprokam is the only licensed product for prophylaxis of POE, although unlicensed intracameral cefuroxime may be administered using pre-filled syringes (PFS), either prepared in hospital by reconstituting cefuroxime via serial dilution (prepared PFS), or commercially purchased (purchased PFS). This study aimed to estimate the potential budget impact of using Aprokam over unlicensed cefuroxime for intracameral administration. METHODS: A budget impact model (BIM) was developed from UK NHS hospital perspective to estimate the economic impact of adopting Aprokam compared with purchased PFS or prepared PFS for the prophylaxis of POE following cataract surgery over a 5-year time horizon. The BIM incorporated direct costs only, associated with the acquisition, delivery, storage, preparation, and administration of cefuroxime. Resource utilisation costs were also incorporated; resource utilisation was sourced from a panel survey of hospital pharmacists, surgeons, and theatre nurses who are involved in the delivery, storage, preparation, quality assurance, or administration of cefuroxime formulations. Unit costs were sourced from NHS sources; drug acquisition costs were sourced from BNF. The model base case used a hypothetical cohort comprising of 1000 surgeries in the first year and followed a 5.2 % annual increase each year. RESULTS: The model predicts Aprokam is cost saving compared with purchased PFS, with a modest increase compared prepared PFS over 5 years. There are total savings of £ 3490 with Aprokam compared with purchased PFS, driven by savings in staff costs that offset greater drug acquisition costs. Compared with prepared PFS, there are greater drug acquisition costs which drive an increased total cost over 5 years of £ 13,177 with Aprokam, although there are substantial savings in staff costs as well as consumables and equipment costs. CONCLUSIONS: The lower direct costs of using Aprokam compared with purchased PFS presents a strong argument for the adoption of Aprokam where purchased PFS is administered. The additional benefits of Aprokam include increased liability coverage and possible reduction in dilution errors and contaminations; as such, in hospitals where unlicensed prepared PFS is used, modest additional resources should be allocated to adoption of Aprokam.

Encapsulation of Vitamin A palmitate for animal supplementation: Formulation, manufacturing and stability implications.

Two manufacturing methods and numerous formulative approaches have been evaluated to obtain a stable oral pharmaceutical form of Vitamin A palmitate (VAP), a substance very sensitive to light, temperature, humidity and metal ions. The best results were obtained by formulating VAP, stabilized with butylated hydroxytoluene (BHT), in double layer microcapsules constituted by a core of chitosan, Tween 20, CaCl(2) and EDTA surrounded by a first chitosan-alginate membrane and an outer membrane of calcium-alginate. This formulation design enabled the production of beads with high drug loading (42% w/w) and high encapsulation efficiency (94%). The stability of VAP-loaded microcapsules was assessed according to EMEA guidelines. This formulation design showed the best performance in terms of VAP recovery (t(50%) > 360 days) after 1 year of storage at room conditions. This is a very important result considering the poor shelf-life (45 days) of pure VAP stabilized with BHT stored at the same conditions.

[Study on optimization of formulation and preparation process of sinomenine liposomes].

OBJECTIVE: To optimize the formulation and preparation process of sinomenine liposomes. METHOD: Method of aether injection and mixture uniform design were adopted to determine the formulation of sinomenine liposomes is the proportion of phospholipids, cholesterol and Vitamin E with the index of entrapment efficiency. And the single-factor test was used to study the preparation process of the liposomes, including the volume of buffer solution, the preparation temperature and the ultrasonic time. RESULT: The optimized formulation was that the ratio of sinomenine : phospholipids : cholesterol : vitamin E mass ratio was 8.92 : 60.35 : 28.81 : 1.91. The volume of buffer solution was 50 mL x g(-1) membrane, the preparation temperature was 50 degrees C, and the ultrasonic time was 20 min. CONCLUSION: Satisfactory shape and entrapment efficiency of the liposomes can be obtained by the optimized formulation and preparation process.

Cost of implementing Veterans Administration directives for handling antineoplastic agents.

Directives issued by the Veterans Administration central office for the safe handling of antineoplastic agents are described, and the costs associated with implementing these directives are reported. The directives are similar to other recent guidelines, including those issued by the Occupational Safety and Health Administration. Inventory records for a 12-month period were analyzed to determine the total number of doses of antineoplastic agents prepared and the total number of treatments administered at a 704-bed VA facility with a comprehensive cancer treatment program. For 3112 prepared doses and 2345 treatment regimens, the total cost of implementing the directives was $57,115, including $6,670 for the purchase of a vertical laminar-airflow hood. The VA central office directives represent reasonable guidelines for controlling the potential hazards of handling antineoplastic agents. Considerable expense is associated with implementing the directives; the degree of added expense will vary based on the particular hospital setting, the number of doses of antineoplastic agents administered, and the nature of the oncology services already in place.